Links to 846 Entry-Level Biotechnology & Life Science Jobs

Responsibilities include :Build web applications and APIs aimed at scientific researchers. Improve access to data and metadata throughout the company. Develop data visualizations. Secure customer data and protect customer privacy. Set up reliable, automated infrastructure in AWS. Deliver quality Python and Typescript code.

The successful candidate will have the opportunity to be involved with numerous 3M manufacturing processes, equipment and techniques, in numerous locations throughout the United States and the world. Responsibilities include: Manage project timelines and budgets for assigned projects. Successfully interact with multiple discipline teams including 3M plant personnel, consultants and suppliers. Specify equipment performance and design criteria. Estimate capital equipment and installation costs. Oversee plant equipment layout and design.

We’re looking for enthusiastic and self-motivated individuals to bring their talents to a fast-paced environment. Responsibilities include: Processing next-generation sequencing data, such as RNA sequencing. Developing and applying algorithms such as clustering, principal component analysis and others to biological data such as gene expression information and immune repertoire data. Working with Amazon Web Services to process data. Working with a team of consultants, data scientists, and computational biologists

In this role, you will provide technical expertise and tactical coordination for successful implementation of components, processes and equipment for product development and/or production. Responsibilities include: Design and implementation of manufacturing processes from the laboratory and concept stage through pilot plant and manufacturing scale-up. Responsible for identifying and implementing improvements to both day to day operations and high-level systematic changes associated with ensuring all processes and functions come together to achieve throughput and quality goals. Interfaces with various departments to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Acts as advisor and/or supervises subordinates in solving technical problems. Frequently interacts with departments, peers management and scientists.

Main Responsibilities include: Experimental procedures: Conducts experiments, accomplishes established milestones and summarizes data. Recommends options for other experiments. Presents data within team. Expertise and Problem Solving: Troubleshoots instrumentation or experiments; recognizes and assists with technical problems. Project Planning: Participates in planning project tasks; providing input to accomplish assigned tasks. Lab Safety: Participates in routine maintenance and lab safety. Documentation: Appropriately documents experimental procedures and results according to established guidelines. Quality: Responsible for implementing and maintaining the effectiveness of the quality system.

Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. Core responsibilities include: Identifies and controls Manufacturing process defects (scrap, nonconforming material, custom complaints)by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for querying & bounding data to support implementation of complex & documenting release criteria.; Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. May be responsible for creating risk analyses and FMEAs.;

Responsibilities as an R&D Engineer include: providing engineering support in the creation and development of new medical device products. Main responsibilities include: research, develop, and designs mechanica/electromechanical materials, components, assemblies, and processes. Conducts feasibility studies to verify capability and functionality. Developes new concepts from initial designs, etc.

Candidate will undertake the role of technician quality with some supervision. Daily responsibilities include: CAPA -Provides inputs to facilitate CAPA investigations as required. Investigates standard complaints. Identifies and prioritizes medical and reportable complaints. Monitor performance of manufacturing processes and implement required improvement activities. Manage Product and Process Improvements - Participate in Project and Process improvement activities. Quality/Compliance -Support manufacturing and testing operations as required; adhering to Good Manufacturing Practices and Good Laboratory Practices. etc.

The ideal candidate will have a strong background quantitative laboratory methods and mammalian cell culture. The position will require ability to generate precise, reliable and reproducible data in a timely manner. Demonstrate strong data interpretation skills, ability to troubleshoot experiments and instrumentation, ability to learn and understand new experimental techniques and be able to place data in proper scientific context by consulting and citing relevant literature.

The position is primarily responsible for the screening and characterization of monoclonal antibodies. The successful candidate will play a hands-on role in the company’s use of a wide variety of analytical assays such as ELISA, flow cytometry, Octet, and HTRF. He or she will partner closely with other team members within the group, assisting with every step of antibody development. The candidate will make observations, analyze data, and interpret results with full supervision.

The project coordinator will join a dynamic team within a rapidly growing organization and will be responsible for supporting custom antibody development projects, driving them toward major milestones and successful completion. This position will be an important addition to the US Custom Services team within our Burlingame office. The role will support project management functions including the sourcing of reagents, scheduling immunizations, supporting customer interactions, populating work reports and product datasheets. In addition, the appointed person will assist with the receipt and shipment of critical reagents and data entry.

We are seeking a motivated individual for a research associate/senior research associate position that will specialize in antibody/protein engineering, gene sequencing, mammalian cell culture, and antibody expression/purification. This person will have good opportunity to experience many different areas in therapeutic antibody discovery, molecular biology and cell biology as an integral part of our Antibody Discovery and Engineering team. Responsibilities include: Sequence antibody variable (VH/VL) regions. Construct and validate gene and plasmid constructs. Express antibody/protein genes in mammalian cell systems. Purification of antibodies/proteins

The Product Development Technician is responsible for assisting in various Product Development projects. Duties include: maintaining, modifying and repairing H-Series and Radixact Radiation Delivery Systems; maintaining and repairing test and lab equipment; performing tests, measurements, and analysis; assisting Engineers with various Product Development tasks; selecting and purchasing supplies, components, and assemblies for maintaining and testing. Duties include: Maintain, test, troubleshoot and repair radiation delivery systems and associated bunker support instrumentation, in accordance with quality system requirements and associated manufacturing and service procedures. Manage inventory of spare and alternate parts necessary to maintain and reconfigure radiation delivery systems; procure replacement/new parts through supply chain, manufacturing, and/or service as-needed. Obtain required data sets; assist in analyzing and presenting findings.

Employee will carry out manufacturing practices in a cGMP biotechnical facility. The job involves the manual processing of porcine urinary bladders, which includes all aspects from collection of raw materials to packaging of the final product. Following training, work will be expected to be performed independently to a high degree of standard in biomaterial handling.

The position will design and coordinate experiments which leverage Adaptive’s unique platform to realize the company’s strategic objectives in hematology, immunology and oncology. Responsibilities include: Develop new assays for immune system profiling by next generation sequencing in collaboration with a team of other researchers. Develop new methods and technologies for project advancement including novel molecular biology methods, streamlined protocols, and automating tasks. Transfer developed methods and/or assays into SOPs for the development laboratory and/or production laboratory . Responsible for analyzing data and reporting findings to their supervisor

This position is responsible for supporting the Quality Management System (QMS) by working with production staff to ensure compliance with regulatory and internal process requirements. The position is accountable for the applications of industry quality requirements, standards, and tools to continually improve the quality systems established at Adaptive Biotechnologies. The position requires the ability to manage priorities from multiple projects and tasks while utilizing effective written and oral communication skills. This position will develop quality systems knowledge, and apply that knowledge through reasoning and judgment, to ensure an appropriate balance of quality, compliance, and business needs.

Reporting to Senior R&D Scientists, the Research Associate will be a part of our growing lab group that is responsible for generating and characterizing test materials to support manufacture process development and preclinical studies required to rapidly advance Affigen’s patient-specific monoclonal antibody therapeutics into the clinical-phase. In this role, the Research Associate is expected to take ownership of specific processes, assays or instrumentation (listed below) and act as the in-house subject matter expert in these functional areas. In addition, the Research Associate will be required to perform miscellaneous laboratory duties that may broadly traverse aspects of upstream, downstream, and analytical development and general research support. A successful candidate for this position will be performance-focused, detail-oriented, and capable of filling a multidisciplinary supporting role across multiple research and development activities through excellent communication, documentation and teamwork skills.

The Manufacturing Associate performs GMP manufacturing operations safely, reliably and in compliance with stated processes. PRINCIPAL RESPONSIBILTIES: Execute unit operations described in standard operating procedures and batch records. Perform bioprocess operations such as filtration, purification, cell culture or recovery. Perform review of GMP documentation. Clean, assemble/disassemble, sterilize and operate primary process equipment.

AGTC is seeking a highly motivated individual to support our drug development activities. They will be responsible for discovery research, implementing a scientific plan, and working independently in the lab with minimal supervision. Duties include: Target validation of candidate capsids, promoters, gene constructs, etc. Develop and qualify new assay methods. Execute routine assays and procedures. Collect, analyze, record, and summarize data. etc

Formulation Technician I will be responsible for performing formulation of pharmaceutical and ophthalmic product solutions for lyophilized products. Assures proper documenting procedures and transfer of solutions to appropriate areas. Supports the development of products or processes, quality control, and proper maintenance of environmental standards. Duties include: Formulation of product solutions as well as cleaning/sanitizing solutions. Set up / Post use cleaning of formulation equipment. Transfer of product and non-product related solutions to filling areas. Following Standard Operating Procedures and Batch Record processes. Assuring proper documentation of all duties performed and material usages.

You will beresponsible for developing applications and products for Opal Multiplex Fluorescent IHC Reagents which are designed specifically for Akoya’s cutting-edge Mantra and Vectra Polaris multispectral imaging systems.The desired skillset for laboratory work includes the ability to perform immunohistochemistry (IHC) procedures to support theproductdevelopment. Your work will involve manual laboratory work and the use of automated stainersystems for monoplex and multiplex fluorescence tissue staining.

To conduct formulation preparation or analytical test in direct support of the drug development team, including writing documents and reports. Responsible for the maintenance of lab instrumentation and general lab duties. Prepare drug formulations according to established procedures. Analyze test data, recognize results that are abnormal or deviate from those expected. Recognize equipment malfunction and factors affecting measurements and testing. Evaluate and solve problems related to sample preparation, variation and processing

Our Quality Control Analysts are responsible for performing testing and sampling of our products in a laboratory environment. Responsibilities include; Perform all established assays as well as routine and non-routine laboratory testing. Act as primary analyst for production projects and complete appropriate documentation. Perform testing and sampling to support manufacturing, validation, and process development

Responsibilities include: Conduct research on various drug/device interactions as part of the drug delivery and device development process. Analyze and interpret data from various product development experiments. Exercise technical discretion in the design, execution and interpretation of experiments that contribute to project objectives. Contribute to stability studies. Ensure reproducible and reliable results for protocols related to development of drug delivery systems.

The role will use in vivostudies to primarily assess CNS mechanisms through rodent behavioral, histological and biochemical techniques. The role is critical in assisting the scientific team in advancing our therapeutic understandings. This person will be involved in establishing, validating, and implementing methodologies in Alkahest’s laboratories and is thus pivotal to the company’s mission. The studies performed will involve cutting edge science and require innovative concepts and strategies. The role requires dedication to drive science, flexibility, excellent communication and organization, and will interact with a team of scientists and research associates to drive multiple projects in parallel.

Under the supervision of Regulatory Compliance management, the Regulatory Compliance Auditor/Analyst will support all aspects of the Regulatory Compliance processes which include but not limited to the activities listed below. Complies with FDA, ISO, AATB, and all other applicable international and state regulatory requirements, best industry practices and internal processes. Compile Quality metrics for QSMR, Tier board etc. and identify and bring issues to management when a compliance gap or quality issue is identified. Supports LifeCell’s internal audit program and performs assigned internal audits under the guidance of lead auditor in accordance with internal procedures and relevant standards/regulations.

The Lab Ops Associate is based in Irvine, CA and will support Allergan R&D by ensuring optimal operation efficiency of the laboratories. Primary area supported is Research and External Scientific Innovation, and includes multi-disciplinary interaction with EH&S, Managed Lab Services, Facilities & Corporate Engineering, and Pharmaceutical Development with emphasis on planning, coordinating and executing logistical lab operations. Responsibilities include: Scheduling technician visits and escorting the technicians into restricted lab spaces. Tracking research lab equipment including inactive, new, movement, and repair or calibration schedules.

The successful candidate will help to synthesize and purify oligonucleotides for research studies. Additionally, they will evaluate new chemical modifications for their use in the RNAi pathway via synthesis, purification, and characterization of synthetic oligonucleotides. Other responsibilities include: Utilize analytical instrumentation such as UV-Vis spectroscopy, HPLC, and/or LC-MS for the analysis of both crude and purified synthetic products. Effectively troubleshoot synthetic/process issues and independently find solutions. Improve upon and/or develop new methods and automation for the downstream processing of synthetic oligonucleotides and their subsequent analysis/purification and annealing into siRNA duplexes.

The Research Associate I is responsible for assisting senior ATG Lab staff to design and perform research diagnostic assays spanning a wide range of PCR and Next-Generation sequencing technologies. Perform research experiments, such as primer design and preparation, PCR, electrophoresis, gel imaging and analysis, Sanger Sequencing, Next-Gen sequencing library preparation, and sequencing analysis. Aid in the design and development of diagnostic assays for use in a CLIA/CAP regulated setting. Participate in drafting Standard Operating Procedures for new assays.

You will be working in a team that is handling one or two applications. You will be getting requirements from a QA manager and will be with the QA development team. You are responsible for the documentation, development and execution of basic manual test cases. You will also be working with the application development team for creating data sets for testing, debugging issues, and improving products. Your end users are mostly internal and need to be able to support them when necessary.

Responsibilities include: Draw and design parts, fixtures, tooling and test equipment. Write programs for CNC machines and support the tool room in the manufacture of designs. Update all modifications to part prints and 3D data. Measure and determine proper machine function for finial sizing of components. Create new designs for products, production machinery, injection molds, and mold shop tooling and fixturing. etc

The successful candidate will be responsible for support of the development, characterization, scale-up and support of upstream and downstream processes to enable clinical advancement of Amgen programs. The successful candidate will design and execute experiments at the bench scale, spanning the end-to-end drug substance process, including both cell culture and purification operations. The candidate will apply established platform approaches and utilize problem-solving skills to rapidly solve day-to-day experimental challenges. Additionally, the candidate will utilize out-of-the-box thinking to contribute to technology development.

Under general supervision, Associate Manufacturing will perform operations in the Manufacturing area, specifically Purification processes. Operations will be performed according to Standard Operating Procedures (SOPs). Associate will perform and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports. Associate will also perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent the Purification group. Associate may also have the responsibility of owning NC/CAPA’s and Change Control records. In addition, Associate may identify, recommend, and implement improvements related to routine functions.

This position will be responsible for the transfection or transduction of gene therapy-related constructs for the characterization of protein expression efficiency and protein product characteristics across a wide range of therapeutic targets. Duties include: Maintenance of the appropriate cell systems for evaluation of protein expression. Transfection or transduction of transgene constructs into an appropriate cell system to evaluate protein expression and characteristics. Measurement of protein expression level and quality. Tracking progress of multiple protein expression projects and prioritization of parallel projects to ensure timely delivery.

To monitor and ensure all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. To monitor and ensure all phases of drug manufacturing are in compliance with established specifications. To receive, inspect, release and control of labels and outserts. To ensure quality compliance before, during and after each packaging run. Perform Inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures. Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab. Inspection and test of packaging components utilizing various measuring devices such as scales, micrometers and height gauges to determine conformance to specifications. Maintaining detailed records of sampling, inspections and testing activities. Assigning and verification of expiry date and retest date for all the GMP raw materials through vendor COA and in-house COA. Collection of packaged product samples for annual stability.

The IT Support Associate will support team members by providing prompt response to members' problems and requests while managing and maintaining the closing of tickets within Servicedesk Plus ticketing system. As a team member, he/she will function as the primary interface for the Corporate IT Team providing a positive experience for Amneal's team members through tailored IT solutions. He/she will be responsible for team members' computer and account management provisioning and de-provisioning as well as inventory management of equipment. Installation, configuration, and support of network resources including printers, VOIP phone system and other peripheral devices among many other tasks will be a part of daily duties. IT Support Associate will work on all aspects of problem resolution for team members; this includes but is not limited to driving the resolution from IT Support teams, cross-functional organizations, and external vendors. Using your expertise, you will identify opportunities for continuous process improvements and if needed, partner with other Amneal technology teams to design, plan and implement a resolution.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Performs test preparation and setup, and runs required tests for pharmaceutical raw material and finished products, such as bioburden, sterility and endotoxin tests. Performs a variety of tests which directly or indirectly affect product release, and test for the sterile quality of products manufactured by performing the following duties. Analyzes test data collected from experiments using laboratory equipment and chemicals to determine the sterile quality of products produced. Interpret EM plates and RCS strips. Identify isolates recovered from EM plates/strips and bioburden tests. Writes test results and submits reports including required calculations and statistical verifications.

Prepare, collect, and test plant purified water, manufacturing raw materials, product in-process, and finished product, and perform environmental monitoring. With limited supervision, learn and perform critical laboratory techniques and complete original work. Author problem reports and participate in investigations. This description is inclusive of EM and testing duties: actual percentages of time spent on each duty may vary based on business needs.

The Research Scientist I/II is an integral part of the AMRI team, contributing to our success by the synthesis, purification and identification of intermediates and target compounds. Responsibilities include: Synthesize compounds efficiently using literature or in-house notebook procedures. Purify synthesized chemicals to an appropriate degree. The scientist will be able to use the full range of chromatographic, crystallization, and distillation techniques. Analyze and identify compounds using a good range of modern separation and spectroscopic techniques. This will include interpretation of TLC, HPLC, polarimetry, IR, and NMR spectra of moderate complexity.

The Chemist I is responsible for support of the manufacturing department and external customers. The routine functions of the laboratory are testing of raw materials, in-process, end product, and stability samples. The Chemist I will also performs particulate testing and tests plant water for production. The chemistry department is responsible for the successful transfer of new customer products and method testing. Perform routine laboratory testing tasks using equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, Total Organic Carbon analyzer. Have the potential and willingness to train on new techniques

Prepare, collect, and test plant purified water, manufacturing raw materials, product in-process, and finished product, and perform environmental monitoring. With limited supervision, learn and perform critical laboratory techniques and complete original work. Author problem reports and participate in investigations. This description is inclusive of EM and testing duties: actual percentages of time spent on each duty may vary based on business needs.

Position Responsibilities: Assists in material handling, equipment set-up and breakdowns, documents process according to Master Production Records, and works with trained operators at assigned work centers to learn all aspects of the position, including batch record documentation, equipment set-up, operation and clean up.

As a Quality Engineer I, you will learn and develop skills to support medical device quality through design controls, process validations and documentation as part of a cross-functional team. Responsibilities include: Conduct experiments to prove hypotheses. Create and validate test methods for design verification and manufacturing inspection testing by using measurement system analysis, gauge R&R and other relevant techniques. Design engineering test protocols and use a data-driven approach to collect, analyze and summarize data into engineering reports. Perform root cause investigations for design and manufacturing

As a Product Quality Engineer, you will be responsible for working within the framework of a team and performing the following activities: Evaluate the performance of products returned by the customer. Perform device analysis in accordance with model-specific procedures and protocols. Perform root cause analysis to investigate alleged product deficiencies. Propose corrective/preventive actions as required. Compose detailed reports describing results from investigations.

As a Quality Engineer I, you will learn and develop skills to support medical device quality through design controls, process validations and documentation as part of a cross-functional team. Responsibilities include: Conduct experiments to prove hypotheses. Create and validate test methods for design verification and manufacturing inspection testing by using measurement system analysis, gauge R&R and other relevant techniques. Implement statistical techniques to determine sample sizes and levels of confidence. Design engineering test protocols and use a data-driven approach to collect, analyze and summarize data into engineering reports

Duties include: Write, revise and review SOPs. Track and control document flow. Achieve manufacturing and quality records. Ensure auditing and manufacturing documentation is kept up to date. Maintenance of Quality Assurance documentation. Train Production staff training on quality procedures, protocols, and documentation

The Microbiology Technician supports Injectable manufacturing at Congers. The Technician performs duties as needed related to environmental monitoring in the pump manufacturing facility and assists in the technical and quality efforts in the lab. Responsibilities include: Perform microbiology & particulate testing of product and processes (clean room, WFI loop) by accurately following all testing as specified by the appropriate quality documentation. Perform environmental monitoring in manufacturing areas, including tracking & trending test results and performing bioburden sampling in controlled areas. Assist in investigations related to Lab OOS (Out of Specification) and support Production OOS investigations.

On the Software Engineering Infrastructure team, you will apply your expertise in Python and large scale distributed systems, building data processing pipelines and interactive tools.

Associate level position for manufacturing medical devices in accordance with controlled procedures (SOPs) in compliance with Good Manufacturing Practice (GMP) regulations and current GMP (cGMP) guidelines. Manufactures solutions, labels and fills containers, labels and assembles kits. Compiles auditable electronic or paper records of manufacturing, maintains equipment logs and monitors supplies. ​Manufacture product as specified in controlled manufacturing procedures, and in compliance with cGMP regulations and guidelines. Accurately complete documentation in cGMP manufacturing batch records, using Good Documentation Practices

The job requires the application of creative problem-solving approaches to the execution of new biochemical and cell-based assays. The successful candidate will have excellent practical laboratory skills, coupled with aptitude and enthusiasm for automated laboratory assay techniques. Responsibilities include, but are not limited to: Transient and stable mammalian cell protein expression. Execution of new biochemical and cell-based assays. Practical laboratory work, managing day to day tasks and ensuring timely delivery of high-quality results. Utilizing liquid handling systems and laboratory robotics to implement in vitro assays.

The successful candidate will have strong organizational skills and attention to detail, coupled with excellent practical laboratory skills, and aptitude and enthusiasm for automated laboratory assay techniques. Responsibilities include, but are not limited to: Mammalian cell culture. Biological sample banking. Biology and tissue culture lab management, safety program support. Execution of new biochemical and cell-based assays. Practical laboratory work, managing day to day tasks and ensuring timely delivery of high-quality results. Utilizing liquid handling systems and laboratory robotics to implement in vitro assays.

ARKRAY is currently seeking a Laboratory Assistant to perform laboratory testing, data entry, support evaluation studies for quality testing, complaint investigations, and support ARKRAY products. Responsibilities include: Performs laboratory testing and assists in clinical studies to meet QS specifications and to support Operations and D&S activities. Prepares samples for product evaluation including blood, urine, and saliva. Maintains documentation in compliance with applicable regulatory programs. Perform computer entry of data.

We are seeking a highly motivated Cell Culture Biologist with excellent organizational, problem solving, and communication skills to join our Structural Biology group located in Boulder, Colorado. This scientist will be responsible for maintaining and scaling up (≥5L) insect cell and E. coli cultures in suspension for recombinant protein expressions. The individual will also be involved in molecular cloning and construct design. A track record of excellent aseptic techniques and experience in molecular biology and protein expression are essential for this role.

This is an ideal position for an individual with an organic or biological chemistry background who has an interest in projects related to novel technology in synthesis and purification of oligonucleotides and bioconjugates. The successful candidate will be expected to: Perform solid-phase synthesis and purification of oligonucleotide drug candidates. Analyze small-molecule and macromolecular targets using standard methods, such as HPLC, UV-Vis spectrophotometry, mass spectrometry, NMR, etc. Track progress against project timelines, generate regular status updates, and communicate progress and issues to management, including presentation of findings at team meetings

We are actively seeking an Automation Engineer I to provide automation and equipment development and support expertise to the Final Device Assembly and Packaging engineering group. This engineer will be a resource for all activities required to build, program, install, debug, and implement automated equipment. The successful candidate will have strong communication and analytical skills, knowledge of manufacturing process and a Bachelor’s degree in Engineering or Engineering Technology.

Responsibilities as a testing engineer include; Performs mechanical tests according to recognized standards and internal policies and procedures. Compiles, critically analyzes and interprets test data. Prepares clear, complete and accurate technical engineering documentation. Assists with the calibration, safety, maintenance, and efficient utilization of testing equipment. Designs and oversees fabrication of test fixtures as needed. Provides technical support to other department (e.g., R&D, Regulatory, Marketing, Sales). Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

In this position, a successful candidate will apply her/his skills in biology and flow cytometry to Atreca’s Immune Repertoire Capture™ technology. The RA will isolate peripheral blood mononuclear cells (PBMCs), isolate various B and T cells and sort them into microplates in a biosafety level 2 (BSL2) environment. The RA will work in a collaborative environment in the team. Responsibilities include: Isolate peripheral blood mononuclear cells from human blood. Freeze/thaw and stain PBMCs or primary tissues. Sort cells into microplates through Fluorescent-Activated Cell Sorting (FACS). Follow laboratory safety guidelines and practices.

The Associate Manufacturing Engineer is responsible for the development, qualification, verification and validation of manufacturing processes. The Associate Manufacturing Engineer will contribute in creative and collaborative ways to achieve the company’s goals of producing market leading products through positive patient outcomes. Responsibilities include: Review of component designs and identification of Design for Manufacturing opportunities. Work with outside suppliers to define, document, analyze and qualify their manufacturing processes. Able to define, communicate, and develop fixture concepts using internal and external resources.Able to incorporate the capabilities of typical production association into these concepts

Avedro is seeking a highly motivated and versatile individual to join our R+D team as an Associate Formulation Scientist. In this role you will be responsible for assisting with the formulation development and testing efforts within our ocular drug development program. Located primarily at our labs in Burlington, MA and interfacing with other group members in our Waltham, MA offices, you will join a growing dynamic team of interdisciplinary scientists at a world leading company on the forefront of corneal crosslinking science.

We are currently hiring a field-based Specialty Pharmaceutical Sales Representative who will be able to drive branded prescription sales in their assigned territory. The Specialty Pharmaceutical Sales Representative will promote our growing portfolio of innovative, branded prescription pharmaceutical and dietary supplement products in Women’s Health, Hematology, Dermatology, and related specialties. The primary call point will be OB-GYN’s offices in their territory, calling on assigned healthcare providers, informing those providers on the features and benefits of our products to effectively grow our market share.

Must be bilingual (English and Spanish). Responsibilites include: Provide technical support to Manufacturing, Engineering and Quality areas. Improve manufacturing processes. Participate on the evaluation of customer complaints and provide suggestions for process/product improvements. Generate validation protocols and reports for the qualification of process equipments or process changes. Develop and update standard operating procedures for new and existing processes and equipment.

Conduct microbiological analysis on raw materials, solution, and water samples following approved Standard Operating Procedures in an accurate and timely manner. Essential Duties and Responsibilities include: Operate lab equipment such as laminar flow hoods, autoclave, incubators, and other equipment. Read plates and enter test results and other data into LIMS. Initiate paperwork for microbial out of limit investigations and provide needed information to Investigators. Perform monthly safety audits

This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs. Responsibilities include: Review individual complaints and associated service data to determine risk level and complete investigation into the “as “determined” problem code and cause codes for each complaints. Analyze data from various quality inputs (including but not limited to : Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues. Prepare and issue reports based on information analysis. Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.

Responsibilities as Engineer II include: With supervision, perform standard engineering assignments which are typically a significant portion of a larger project. Lead small project teams through the planning, execution, and completion of smaller projects or defined pieces of larger projects. With supervision, lead projects within Baxter’s change control management process, from initiation through closure. Change Owners assign and prepare impact assessments, develop change plans, write and execute engineering studies, while working closely with manufacturing plants, quality, regulatory, purchasing, and various scientific/technical groups.

The position will allow someone who has completed advanced studies in a science or engineering field or a physician to work closely with the radiologists, engineers and physicists at Bayer and take on a project that supports the use of contrast enhanced imaging and associated informatics software. They will be able to understand what the scientists and physicians do in Radiology at Bayer through an in-depth project. A specific project that fits their background and training will be assigned. Projects typically involve the investigation of improvements to imaging in radiology. They involve programming, data analysis and innovative thinking. They may also help develop scientific materials for presentations and help answer scientific questions internally and externally with collaborators or customers.

Responsible for coordinating and providing engineering support throughout the manufacturing facility in areas such as process improvements, technological advancements, cost improvements, facility maintenance, safety, and environmental regulation. Coordinate and participate in plant CIP and process improvement programs as required.Support, or lead as required, activities such as failure investigation, design of experiments, process capability studies, qualifications, and validations of processes and equipment. Coordinate tactical plans geared towards timely completion of line extensions and major equipment installations, modifications, or enhancements.

This position is responsible for coordinating and providing engineering support throughout the manufacturing facility in areas such as process improvements, technological advancements, cost improvements, facility maintenance, safety, and environmental regulation. Essential job functions include: Coordinate and participate in plant CIP and process improvement programs as required. Support, or lead as required, activities such as failure investigation, design of experiments, process capability studies, qualifications, and validations of processes and equipment. Coordinate tactical plans geared towards timely completion of line extensions and major equipment installations, modifications, or enhancements.

The responsibilities of this position are production, bottling, and packaging of methylcellulose-containing and other cell culture media. Perform QC testing of methylcellulose-containing cell culture media. Perform cell culture of multiple cell lines. Production of components for additional stem cell, and non-stem cell kits. Skills used include cell culture, high attention to detail, strong communication and organizational skills. Perform additional duties as assigned. This will be a Sun through Thurs work schedule.

The responsibilities of this position are to characterize monoclonal and polyclonal antibodies on natural samples using Western blot and Simple Western. Screen multiple sera or hybridoma culture supernates to select potential products. Validate purified antibodies using natural samples. The person will develop problem solving and decision-making skills, while maintaining appropriate contact and communication with the supervisor. Maintain and treat cell lines for needed lysates. Refer to pertinent literature, databases and competitor product information on specific antibody targets. Maintain clear notebook, enter data in PDPT and perform calculations.

As a Production Assistant 1, you will be responsible for the processing of raw biological material for use in product manufacturing. You will also perform maintenance and cleaning of production equipment and containers to ensure safety and compliance, as well as completing required paperwork.

Bio-Technical Resources is seeking an Assistant Research Scientist to work with supervision as an analytical research assistant supporting teamsdeveloping fermentation and biotransformation processes for the production of antibiotics, enzymes, proteins, chemicals, and metabolites. The position involvesimplementation of HPLC, chromatography, enzyme assays, and gel-basedanalytical methods.Common tasks include analytical separations and quantitative analyses

We are currently looking for an enthusiastic research associate to join our R&D team. This position will entail developing novel assays kits and performing service projects. This candidate may also be involved in manufacturing or providing technical support to customers.

The Sales Associate will be responsible for processing orders, preparing shipping documents, and keeping detail records. The individual will have to communicate with our customers by phone, fax and e-mail. The position will also involve packaging products for shipment.

The Clinical Research Coordinator I (CRC I) is responsible for managing clinical trial performance and ensuring the conduct of their clinical trials is congruent with the philosophy and mission of the company. The CRC I plans, coordinates, evaluates, and manages the care of both the participants and the data for their assigned research projects. The CRC I follows study-specific protocol guidelines and communicates and interacts with Investigators, clinic staff, sponsoring agencies, and others to effectively perform clinical research and to coordinate research activities. All duties carried out by the CRC I are done so in accordance with company policies and SOPs, as well as all applicable local, state, and federal regulations. Professionals in this role actively participate in outstanding customer service and accept responsibility for developing and maintaining mutually respectful relationships.

Ensures software applications are accurate, complete and conform to all user, company and regulatory requirements by: Tracking all software versions, features, bugs and validation efforts for all software created and/or modified by the Development teams. Creating and executing manual test scrips which includes testing software applications for quality and functionality using defined validation protocol and testing techniques. Working with application developers in resolving issues and retesting applications. Partnering with technical and business teams to achieve understanding of current and future functionality.

The Laboratory Assistant must demonstrate knowledge of specimen collection and processing and handling requirements as relevant to Bioclinica Research and must have a thorough knowledge of lab procedures and practices. Responsibilities include: Perform blood draws, specimen collection, take vital signs, perform EKG testing and able to record accordingly. Timely specimen preparation for processing and shipping. Effectively and professionally interact with patients, visitors, peers and other healthcare professionals

Medical Assistant works in a clinic setting and handles basic clinical task and performs administrative/office duties. Interacts with patients and assist physician to ensure operations run smoothly and efficiently. Answer incoming calls, take messages and/or respond to all calls within 24 hours. Schedule patient appointments. Perform clinical task including but not limited to vital signs and height/weight; document medical history in patient charts. Prepare patient for examination. Ensure examination room is clean, well-equipped, and ready at all times

Biodesix is accepting resumes for a Laboratory Technician to process molecular and proteomic Laboratory Developed Tests (LDT’s) from blood based specimens. Laboratory Technicians must have the technical training and experience required to perform regulated clinical laboratory testing, including sample accessioning and processing using standard in-vitro laboratory techniques which include DNA and RNA extraction from whole blood, ddPCR (digital droplet PCR), Mass Spectrometry for proteomic testing and to operate a proprietary LIMS.

The primary functions of this position include culturing, setting up, feeding, maintaining, and harvesting of bioreactors with hybridoma cells, finding, testing, and developing new procedures to increase the quality and efficiency of our product and processes, and maintenance of regularly used equipment. This position offers a varied work load and will enable you to gain solid experience that will allow you to grow and increase your skill set within a fast-growing and stable biotech company. This position will also allow you to gain experience in all areas of tissue culture and cross training on a variety of other supporting tasks such as downstream processing, ELISA assays, qPCR, mycoplasma detection, and NOVA BioProfile 400 use and maintenance.

The Manufacturing Associate will be an integral member of a team that ensures the highest quality of our finalized antibody products. This position offers the opportunity to gain experience with different types of conjugation chemistries and different chromatography methods to purify antibodies and offers the opportunity to work in small scale to large scale product projects and to learn to utilize the (Enterprise Resource Planning) ERP database to track production schedules and deadlines and to enter production results. This position will also perform scale ups and perform troubleshooting of problematic products, including continuous improvement methodologies for efficiency.

BioLegend has an immediate opening for an ELISA Research Associate who will become an active member of our team who develop high quality ELISA products including proteins, antibodies and assay kits. The Research Associate will participate in all stages of the produce development process from product design, material sourcing, optimization, validation and product launch.

This position is responsible for developing recombinant protein research products in the Molecular Cellular Immunology group by using cutting-edge synthetic biological technology. The duties include preparing buffer solutions and cell culture media, performing bacterial, insect, and mammalian cell expression, purifying recombinant proteins with chromatography, and performing molecular cloning, PCR, and DNA purification according to standard operating procedures. This position offers a significant opportunity for learning protein production techniques and career growth in biotechnology industry.

We are looking for highly motivated and hardworking Research Associate I/II for molecular biology and AAV production to coordinate and perform activities required to generate early stage material for the therapeutic programs at discovery stage. Responsibilities include: Operations of bench-scale bioreactor, Cell culture for insect and mammalian cell lines, Molecular cloning and PCR based quantitation

The Research Associate will be part of a stablished team of scientists and RAs working to develop and optimize AAV vectors production processes and assists team members in molecular biology and cell culturetasks including:Nucleic acid/plasmid purification. Cell propagation and plasmid transfection.Clone screening and selection. DNA analysis by agarose electrophoresis. PCR. DNA quantification by qPCR or ddPCR. etc

This technician works within a project team under the leadership of a more experienced individual such as a team lead, project lead, or project manager. The technician is expected to perform various types of technical activities including design, development, testing, verification, and documentation. This technician is expected to work and communicate well with other members and leadership of the team in order to meet the goals of the project.

We are looking for someone to confirm/correct our drug pipeline data on a contract basis. You should have some knowledge of drug indications and clinical phases of drug development. If interested, send us a message via our contact form. Must be able to accept payment via PayPal

This position will provide support for clinical research functions of project teams by supporting all aspects of project initiation through project closure. This will include performing administrative functions, maintaining general and study site files, data entry and interfacing with site coordinators, field clinical staff and other company representatives, as well as other project-specific duties.

The Chemist conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products using HPLC, GC, Dissolution, AA, UV-Vis, Wet Chemical Analysis and Method Development. Responsibilitiesi include: Prepares and analyzes products to determine chemical and physical properties. Follows all safety rules and regulations and conducts periodic safety audits. Under close supervision confers with chemists and other client personnel regarding research, procedures performed, related results and prepares reports. Performs routine data generation and problem solving with a minimal rework.

The Rhythmia Specialist will provide expert clinical product and technical assistance and training to physicians, EP Lab Staff, and sales representatives on the effective and safe use of the Rhythmia System during case procedures within an assigned geography, and in a manner that leads to meeting and exceeding business goals. Serves as primary resource for clinical support in the areas of case coverage, basic troubleshooting, system/software development for Rhythmia System and catheters. Educates customers and internal BSC employees on the merits and proper clinical usage of Rhythmia by giving presentations and demonstrations using a wide variety of formats and platforms (e.g., slides, transparencies, manuals) to keep all abreast of the latest product and technology developments for Rhythmia system.

The Research Scientist II will support execution of neuromodulation research projects (computational, preclinical, and exploratory clinical studies). The successful candidate will primarily focus in the area of deep brain stimulation, supporting future technologies and participating in the definition and execution of multiple projects that address strategic, scientific, and technological needs for the organization.

The Manufacturing Investigator I in this role will be part of a cohesive team responsible for Deviations and CAPAs for all phases of manufacturing. The Manufacturing Investigator I uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness. The incumbent will also support investigations and improvement initiatives within the manufacturing operations. Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

(Overnight Position) The QC Associate I will work in the QC cGMP compliant Laboratories to develop, qualify, and conduct microbiological assays that support quality control of biopharmaceutical products being developed and manufactured at Brammer Bio under contract. Normal working hours will be 7:00 pm - 7:00 am on a shift rotation. Occasional off-shift work/holiday work will be required to support business needs. Duties include performing routine microbiological assays and testing including but not limited to environmental monitoring, bioburden and endotoxin testing. The QC Associate I will also troubleshoot and optimize assays under the supervision of QC Microbiology management . Functions also involve raw data review and document management, maintenance (routine and preventive operation) of equipment, and supporting routine laboratory operations (cleaning the laboroatory, inventory control, etc)

As API Process Engineer, you will work as part of a cross-functional matrix team to ensure successful manufacture of active pharmaceutical ingredients, chemical intermediates and specialty materials to support development of R&D pipeline products. Provide process engineering expertise within process planning workflows and document reviews for internal and external manufacturing implementation including: tech transfer documentation, data/process knowledge collection, equipment setup, process modeling, process flow diagrams, compatibility assessments, risk management, etc. Perform engineering analysis of process execution, recommends opportunities for improvement with plant efficiency and risk mitigation as goals, and captures analysis in campaign summary documents

Support the operation of GMP / Non GMP manufacturing systems (Systems include Process Automation Systems, Manufacturing Execution Systems, Process Development, Technology Transfer, Laboratory, Manufacturing Operations) in the associated facilities. Provide Troubleshooting support and guidance of systems in support of manufacturing, process development, and/or Lab operations within a collaborative team. Collaborate in investigations of proprietary automation software/hardware, manufacturing operations, process development, along with vendors when necessary. Documentation of data and results, data verification, interpretation of small scale and at scale data supporting the manufacturing processes and preparation of final reports to summarize the findings.

Responsible for design/development, modification, and evaluation of primarily mechanical systems, equipment and packages. May contribute to total systems engineering, including other eng. disciplines. Conducts feasibility studies and tests new and modified designs. Is involved in all phases of development from initial concept to manufacturing. Directs support personnel in the preparation of detailed design, design testing and prototype fabrication. Provides design information to drafting for packaging documentation. Depending on level may function as a project engineer/leader with the resident responsibilities of proposals/project plan, schedules, work assignments, prime contact, technical presentations, cross functional issue resolution, etc.

As a Manufacturing Quality Engineer, you will be the primary quality interface for new and existing products. You will design, develop, and execute quality assurance and control systems. Use your expertise and judgment in implementing a wide variety of quality concepts, practices, and procedures. You will contribute to product and manufacturing process design, as well as the methods for verification and validation of product to ensure adherence to company and customer requirements. You will work toward the prevention and/or resolution of product and manufacturing process non-conformance. You are well versed in working with Contract Manufacturers (CM) and Component Suppliers. You will lead teams to ensure products are designed and built to Bruker’s high standards of quality and performance. You will evaluate the product designs and create the processes, tools and procedures behind Bruker’s world leading Handheld X-Ray Fluorescence (XRF) products. You will collaborate with Commodity Managers and Design Engineers to determine Bruker’s manufacturing and product specifications

As an Analytical Scientist in our Quality Control unit, you will perform release and stability testing of materials for manufacturing of drug substances and drug products including raw materials, starting materials, intermediates, excipients and cleaning samples. You will operate HPLC, Dissolution, GC, KF, FTIR, and other laboratory equipment in a cGMP environment. Additionally, you may write standard operating procedures (SOPs), stability protocols and reports.

The Assembly Technician I will be expected to perform basic functions to complete day-to-day production activity. The position requires a highly motivated, positive individual that can work both independently and in a “team” environment. Assembly Technician I level employees will be expected to perform all job duties in the areas they are assigned under basic supervision. They will stay on task and complete quality work with accurate documentation. He/she will be a valuable and trustworthy asset to their work area through quality work of trained processes. This individual must be dedicated to the success of CSI and its quest to continually improve its operations, as well as perform duties to manufacture CSI products, meeting FDA, OSHA, GMP/MDD and ISO compliance requirements.

The position will be responsible for downstream purification of recombinant viruses and will be a key member of the team developing expression and purification strategies for novel gene editing/gene therapy vectors. Responsibilities include: Contribute to a smart, integrated development approach for definition of scalable viral vector processes and suitable control strategies. Plan and perform experiments to develop purification process steps including chromatography (affinity, IEX, HIC, SEC, etc.) and filtration (depth filtration, UFDF, and sterile filtration). Perform experiments to develop robust downstream unit operations, using DoE, multivariate analysis, and other statistical tools.

The individual should possess strong core competencies in cell biology, molecular biology, assay development. Responsibilities include; Cell culture and cell line development using retro- and lenti-virus, CRISPR and downstream analysis of autophagy and signaling. Perform western blotting, FACS and imaging analysis to analyze autophagy and specific target activity in primary cells and cell lines. Aid in conducting genome-wide CRISPR screens for novel target ID. Use mouse tissue to both aid in the development of novel biomarkers and analyze key targets by protein and gene expression.

The Laboratory Technician will support the needs in the laboratory for the Product Development department, including raw material sampling/ordering, maintaining inventory of supplies in the lab, preparing dissolution & HPLC media, maintaining equipment in a qualified/calibrating state, contacting vendors for equipment maintenance, working with the scientist to assist with daily lab experiments and helping to prepare samples, lead lab waste management initiatives and act as a safety officer for the lab, etc.

The Associate I, cGMP Biomanufacturing is responsible for current Good Manufacturing Practices (cGMP) production activities, including Master/Working Cell Bank production, Upstream cell culture, Downstream protein/mRNA purification, and/or Fill/Finish. This position is a Sunday - Wednesday, 6:00 am – 4:30 pm shift. Responsibilities include: Performs aseptic techniques within in a clean room environment. Executes and properly documents cGMP Biomanufacturing activities. Operates cGMP Biomanufacturing equipment, including pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and analytical equipment as applicable.

As a Biomanufacturing Upstream, Associate Two you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) Biomanufacturing activities. Operates cGMP Biomanufacturing equipment, including pH/conductivity, meters, mix tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH). Perform basic cell culture work, including but not limited to working inside of a biosafety cabinet, cell counting (automated and manual), performing manipulations of required cell cultures in an ISO 5 environment, and analysis of cell culture samples using applicable analyzers.

The Associate Quality Assurance Systems, Document Control is responsible for managing the flow of document review, making documents effective and distribution according to standard operating procedure (SOP). The Associate Quality Assurance Systems, Document Control will correspond with customers to obtain document approval. Responsible for the process of document control, including managing drafts, editing, approval, change control, distribution and archiving, of all controlled documents (e.g. Standard Operating Procedures (SOPs), Batch Production Records, Stability Protocols, Qualification Protocols, Specifications, Equipment Records, etc). Edits Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and reports independently and accurately.

Performs tasks from detailed instructions and established procedures. After conducting basic analysis, interpretation and evaluation of results, work is reviewed for soundness of judgement and adherence to procedure. Execute laboratory work plan / schedule developed by supervisor or senior team member. Edits technical documents, such as test methods, with direct guidance from a supervisor or senior level scientist.

Responsibilities include: Write and review statistical analysis plan. Write and review the statistical and related sections of clinical protocols. Provide statistical guidance and input to authors of clinical study reports, development plans, and other regulatory documents to ensure accuracy and quality. Interacts with sponsors, investigators, and other consultants to determine the best clinical trial design. Performs the design, development, modification, and evaluation of technical infrastructure to expedite conduct and evaluation of clinical trials and basic research

Responsibilities as a clinical data programer include: Provide data programming support to project teams for reporting and analysis of clinical data in early clinical studies. Develop, maintain and process SAS programs for standard studies that create case report forms (CRFs), edit checks (clinical), data listings, analysis data sets and electronic data transfers.

Manufacture human blood derived cell therapies per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment of a multi-product clinical facility under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.

We are seeking a Research Associate to join our Validation Systems Core (VSC) team within our Product Development organization. The VSC serves as a centralized resource for innovation in the culture, treatment, lysis, and storage of cell lines. The Research Associate is responsible for providing well-characterized, high quality cells and lysates to the organization to support Product Development efforts focused primarily on affinity research reagents such as primary antibodies, in addition to other product types such as assay kits, conjugates, and ELISA pairs.

The position will be working in a chemical lab that manufactures liquid reagents in bulk quantities. Responsible for the overall operation of the bulk lab throughout the shift and ensure that all activities are compliant with the company’s Quality, Safety and departmental policies and standards. Essential functions include: Formulate bulk liquid reagents following standard operating procedures. Work safely with hazardous chemicals and follow all Safety policies to ensure zero incidents in the lab. Recommend or suggest improvement ideas in the lab that will positively affect production efficiency, Quality and Safety compliance

The Manufacturing Lab Technician I will work directly with Viral seed culture and Virus propagation techniques, prepare buffer/media solutions and equipment preparations, and inactivation methods following aseptic technique and cGMP procedures. Operators will be in a full gowned environment and will be need to use strict aseptic techniques.

Support in vivo oncology studies in mice as a member of Necropsy Services. Allocate animals to study. Assist with gross necropsies (dissection, tissue trimming/collection/preservation, sample collection). Perform preparation activities, including container and tube labeling and room set-up. Collect, process and maintain blood and tissue samples. Assist with the tracking and shipment of samples to sponsors and diagnostic laboratories.

Provide chemistry and formulation support for vivo oncology studies. Collect and document pertinent data, including lot information, COA, and MSDS, for the receipt, distribution, preparation and disposition of test compounds, reagents, and carriers/vehicles in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines. Prepare and dispose of test materials, vehicles, and reagents according to study protocols and SOPs. Monitor test materials and help maintain facilities for cleanliness, safety, and regulatory compliance. This includes glassware and waste processing.

Performs technical laboratory activities in support of client studies or procedures. Performs analysis of data for quality and completeness and determines if results are as expected. Records data in compliance with company and regulatory policies and standards to meet quality and accuracy requirements. Perform within the Bacteriology laboratory process internal and external rodent samples by for microbiological identification. Reconcile customer paperwork with submission documentation to ensure accuracy. Make detailed observations and maintain documentation of all laboratory work. Comply with all Standard Operating rocedures (SOPs) and operating equipment and hazardous and non-hazardous chemicals and biological material according to laboratory safety policy

The following are responsibilities related to the Quality Assurance Auditor 1: A Quality Assurance (QA) Auditor I is responsible for performing audits of basic records and reports and inspections of routine processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures.

The Technician I will perform routine animal husbandry and other production duties, and maintain supplies and environment of environmentally-controlled work area(s). Other essential duties and responsibilities include: Perform routine animal husbandry duties and monitor daily health and welfare to maintain quality and health of animals. Handle, transfer, and distribute animals, supplies and waste as needed to and from work area(s). Perform physical environment housekeeping duties and production operations according to Good Manufacturing Practices (cGMPs) and/or Standard Operating Procedures (SOPs). Maintain recordkeeping pertaining to equipment operation, animal or supply area inventories.

This position will be responsible for handling and processing samples, and performing accurate data collection and reporting. Basic methods will be used to perform laboratory tasks with minimal supervision in the performance of studies.

This position will be involved in all aspects of studies supporting the bioanalysis of drug molecules in multiple matrices.  The position is hands-on, working in close cooperation with and under the guidance of more senior staff members in a fast-paced environment where a commitment to teamwork, quality data and speed is essential.

A Research Technician is responsible for: administering substances to animals, performing husbandry duties, including cleaning/transporting caging and providing food and water; performing clinical observations of animals to determine morbidity/mortality; collecting and handling data and specimens; euthanizing animals and assisting veterinarians, management, and other company personnel with animal care, study-related tasks, and process improvement initiatives.A Research Technician is responsible for: administering substances to animals, performing husbandry duties, including cleaning/transporting caging and providing food and water; performing clinical observations of animals to determine morbidity/mortality; collecting and handling data and specimens; euthanizing animals and assisting veterinarians, management, and other company personnel with animal care, study-related tasks, and process improvement initiatives.A Research Technician is responsible for: administering substances to animals, performing husbandry duties, including cleaning/transporting caging and providing food and water; performing clinical observations of animals to determine morbidity/mortality; collecting and handling data and specimens; euthanizing animals and assisting veterinarians, management, and other company personnel with animal care, study-related tasks, and process improvement initiatives.

The Research Technician will collect and record data with minimal supervision in the performance of studies.  During a typical day, you can expect to perform clinical observations, sample collection, monitoring of food consumption, animal husbandry, and accurate data collection and reporting, along with the handling and restraint of animals.  Additionally, you will also administer test substances by various basic methods, perform study preparation activities, read basic study protocols and extract pertinent information, review documentation of performed functions, maintain a clean work area, receive animals of all species (general health observation, sexing and identification), and perform all job functions using Good Laboratory Practices (GLPs), Standard Operating Procedures (SOPs), processes, and company policies.

Perform multi-step organic synthesis in solution and/or solid support: Optimize conditions to achieve desired yield; perform and interpret data analysis such as LC/MS and NMR; perform purification steps such as extraction, recrystallization, silica gel column chromatography and LC/MS purification; perform cGMP synthesis of pharmaceutical ingredients; and perform process development and scale-up for kilogram quantities; and clearly record and communicate results and challenges to coworkers/supervisor. Equipments and tolls used included NMR, UV, MS and IR, Reactor (from 50ml to 221 to 10000l), vacuum pump, water aspirator, condenser, rotavap, voltage transformer, chromatography columns, TLC monitor, lyophilizer, separation funnel and addition funnel.

Assist in managing all aspects of clinical trials to ensure that studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. Assist with the management of key study parameters (e.g. start-up activities, enrollment, site management, data collection, data reviews, site feasibility, database lock, etc.) and proactively identify solutions within the clinical team when issues arise. Develop and review informed consent forms, case report forms, study manuals, and other clinical trial materials. Assist in the evaluation and management of CROs and other vendors and systems. Negotiate and manage contracts/budgets with CROs and other vendors.

In order to support cochlear implant clinics and recipients, we are recruiting for an Insurance Verification Specialist. To be successful in this role, you will facilitate all pre-claim activity for reimbursement orders while providing exceptional service to internal and external customers. You will act with a sense of urgency to address inquiries while demonstrating a high degree of knowledge, integrity, and empathy in all aspects of team performance and operations.

We are looking for an entry level Research Assistant interested in analytical method development and protein biochemistry. Successful candidates will be part of an interdisciplinary, dynamic and enthusiastic protein engineering team responsible for implementing Codexis’ core technologies and delivering commercially-relevant and highly-evolved proteins. Responsibilities include; Assist in developing relevant enzyme assays in HTP format. Grow cultures, express proteins, and test enzyme activity in high throughput and in larger scales. Analyze HTP samples in HPLC, UV-Vis Spectrophotometry, GC, LC-MS, or GC-MS to identify and quantify small-molecule products.

The Laboratory Technician ensures the quality of products by developing, validating and documenting analytical methods and performing physical and chemical analyses of raw materials, in-process and finished products in support of the manufacturing process. Perform test sample extractions or dilutions and execute instrumental analysis using high performance liquid chromatography (HPLC). Perform other laboratory testing as required, including but not limited to, GC, LOD, Ash, and particle size analysis (sieve method). etc.

As a QA Chemist, you will be is responsible for performing inspections and tests on raw materials, in-process products, bulk products, finished goods and stability samples to ensure conformance to established specifications. Perform in-process inspections and determine any adjustments required. Perform bulk and finished product inspections, testing and analyses. Confirm samples meet established standards and specifications and release items as appropriate. Develop and validate analytical methods based on USP requirements and local needs and available instrumentation. Record test data and results using standard laboratory data calculations. Verify notebook entries and calculations for lab staff. Assure equipment is calibrated prior to use and complete preventative maintenance. etc.

The successful candidate will be responsible for developing and executing standard work procedures on a wide range of molecular biology techniques related to Next Generation Sequencing. Execute on and assist in the development of process instructions that ensure accuracy, throughput, and quality. Operate and monitor laboratory automation and instrumentation. Communicate issues and failures as necessary to the appropriate parties. General lab duties, such as restocking supplies and maintaining inventory.

This position is responsible for operation of Pre/Post machining from start to finish for hip stem and hip acetabular Cups. Responsibilities include: Printing DHR’s for production release of hip stem and acetabular cup . Programming of acetabular cup and hip stem . CNC operation of acetabular cup and hip stem . Comply with all company policies and procedures including safety regulations, personal protective equipment requirements, Standard Operating Procedures, Work Instructions and Good Manufacturing Procedures

Purpose: Produce parts that meet requirements using a variety of manual and/or automated equipment through established procedures. Accurately perform basic metrology tasks utilizing basic measurement devices such as calipers, micrometers, etc. Set-up and operate various manual and automated production machines where set-up is well defined and operate simple CNC type machines that are already set-up for production. Must be willing and able to continually rotate through a variety of manufacturing processes and duties, performing all types of tasks in a cell/team environment.

The Quality Engineer at Cook Medical is responsible for executing and/or monitoring key processes in support of the Quality Management System: auditing; complaint investigation; corrective and preventive action (CAPA); control of non-conformances; document, data, and change control; process control; risk management and supplier quality management. The Quality Engineer fulfills the role of Independent Reviewer of many key process outputs

The Regulatory Engineer provides technical support to Regulatory Affairs for the development of regulatory documentation for compliance with FDA and international regulatory requirements. Develop new, and refine existing, systems that provide the necessary information for successful submission to global regulatory bodies . Assist various Regulatory Affairs staff with technical assessment and writing of regulatory submissions and responses to regulatory agencies. Prepare regulatory submissions for new products, product changes, and re-registrations, as required. etc

Position Overview: Perform work station assembly operations including sewing and packaging of heart valves in a clean room. Inspect incomplete and finished components for conformance to written specification with the aid of a microscope, and follow standard work methods and practice safe work habits to ensure production is as efficient and safe as possible.

The incumbent will be a shop floor employee in the manufacturing organization. The incumbent will provide (be trained in) the technical skill-sets necessary to manufacture high quality biologicals or sterile injectables safely in a compliant, efficient, and cost effective manner. Responsibilities include; Becomes trained on basic processes and equipment and serves as a hands-on resource in Production. Cleaning, preparing, and sterilizing production equipment. Assembly, set-up, and disassembly of production equipment. Handling biologically and chemically hazardous goods

Key responsibilities include: Participates in gathering requirements (user requirements, business process requirements) from business users using appropriate mechanisms and following CSL standards. Responsible for identifying the design of approved changes and updating/creating the required system design documentation (design details, diagrams and charts, functional and configuration specifications) to ensure the visualization of the technical implementation. Contributes to the compilation of validation testing. Responsible for the ongoing operation and maintenance of applications for the assigned IT functional areas. This includes providing 2nd or 3rd level incident support, change management, and maintaining the upkeep of technical records and documentation.

The incumbent will be a shop floor employee in the manufacturing organization. The incumbent will provide (or be trained in) the technical skill-sets necessary to manufacture high quality biologicals safely in a compliant, efficient, and cost effective manner. Responsibilities include: Ability to learn basic processes and equipment and serves as a hands-on resource in Production. Cleaning, preparing, and sterilizing production equipment. Assembly, set-up, and disassembly of production equipment. Interfacing with process automation systems and electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP, LiveLink)

The main responsibility of the Manufacturing Sciences technician is to support the manufacturing team as a technical advisor and operator. Manufacturing Sciences technicians adapt processes demonstrated at the R&D scale to final manufacturing scale. Secondary roles include driving/contributing to continual improvement initiatives and providing input to production scheduling

This position will report to the Principal Investigator – Biological Sciences in the Lawrence, KS research facility. Key responsibilities include: Perform primary screening of small molecules utilizing cell-based assays. Primary responsibility will be in the area of screening small molecule kinase inhibitors. Perform routine mammalian cell culture. Together with supervisor, responsible for validating new biochemical or molecular biology-based assays and trouble-shooting when needed to establish reliable screening platforms.

This position will report to the Sr. Manager, Regulatory Affairs and be located in the Waltham, MA office. Responsibilities include: Under supervision, the Regulatory Affairs Associate will work with cross functional colleagues in providing support for clinical and CMC regulatory filings, creation of internal regulatory documents, and assist with ensuring internal compliance with GXP regulations and policies. Define contributions for submissions, communicate to functional contributors and track delivery according to agreed timelines. Identify and compile all materials required in U.S., EU, and other ex-US regulatory submissions, this includes annual reports, DSURs for INDs, CTAs, IND/NDA/MAA applications, etc. as necessary

Collaborates with various departments on the design, documentation, testing and implementation of clinical data studies. Develops systems for organizing data to analyze, identify and report trends. Analyzes the interrelationships of data and defines logical aspects of data sets. Prepares reports of clinical trial studies for internal validation and cross validation studies. May evaluate and resolve issues regarding contents of reports.

Under the direction of the Operations Mechanical Engineering Manager, the Mechanical Engineer provides technical support for the projects, functions, and strategic objectives of the Operations Mechanical Engineering department, focusing on: engineering support for new product development; development of fixtures and equipment as standalone and in support of automated systems; failure mode analysis and corrective action of process equipment and instruments; sustaining engineering for the legacy and newly deployed manufacturing systems; engineering and quality documentation development.

Responsibilities to include: Performing key assays to support drug discovery using biochemistry, cell biology and/or biophysics. Generating high-quality, reproducible data by leveraging liquid handling, laboratory robotics and advanced data analysis tools. Identifying and developing new assays as the project requires. Communicating experimental results to project teams.

Dicerna Pharmaceuticals is looking for a BS/MS scientist to help in its drug discovery efforts. This is a hands-on research position that requires strong expertise in molecular and cellular methodologies. Key responsibilities include: siRNA drug candidate screening, hit identification, and lead optimization. In vivo drug candidate testing (e.g. mouse dosing; sample analysis)

Utilizes a developing to full understanding of operational processes and procedures to perform an assortment of assembly activities of moderate scope on a mixture of products, components, assemblies or sub assemblies. Follows methods, and sequence of operations according to specifications, blue prints and bills of materials. Ensures quality and product conformance. Sets up assembly for production. Performs various tasks which may include but is not limited to: wiring, component installation, hand soldering, cable harnessing, welding, painting, milling, filling, sewing, templating and fitting on assembly units. Performs maintenance responsibilities as needed and keeps surrounding area clean, safe and organized. Develops and recommends new methods to improve processes. Follows and complies with Company policies, standards and practices.

The technologist assistant assists the technologist with patient care by transporting patients between the facility and scanner; sanitizing and cleaning patient care and staff areas; changing table linens; entering exam and patient information electronically or on paper; and answering the telephone. The technologist assistant demonstrates the knowledge and skills necessary to provide care appropriate to the age of the patients served. The individual demonstrates knowledge of the principles of growth and development over the life span. He/she is able to identify and categorize each patient’s age-specific grouping of needs, such as those for infant, pediatric, adolescent, adult or geriatric patients.

Under the direct supervision of the site physician, performs various professional and administrative duties related to nuclear medicine stress testing including but not limited to: patient preparation-including IV start and EKG lead placement interpretation, administration of exercise and pharmacological stress tests, and application of ACLS measures to patients when directed. Activities not performed at the physician site are supervised by the Area Supervisors and Business Directors.

Job duties include: Estimate, plan, and coordinate testing activities. Develop test plan, test cases, test scenarios based on Users Stories and product’s design description to meet business requirements and technical specifications. Perform ad hoc, functional, integration, and regression testing. Identify software defects and submit problem reports via bug-tracking system. Perform regression testing on fixed issues.

Editas is seeking a highly motivated Research Associate I/II to join our Screening Team. In this role, you will contribute to the pre-clinal development of gene-edited cell products. An ideal candidate should have a strong background in cell and molecular biology. Demonstrated culture experience with both IPSC or primary cell lines and a strong interest in genome editing. Experience and interest with lab automation and liquid handling robots, Biomek Fx / I7 or similar, is a plus.

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.

Applies knowledge of technical principles and Edwards systems/procedures to tptimize manufacturing processes. Responsibilities include: Improve manufacturing processes using engineering methods for concinous process improvement. Develop basic experiements and tests to qualify and validate manfactruing process, etc.

Supports all phases of clinical study activities including: TMF review, assist with filing and archiving project documentation in theTMF within a 20 day timeframe. Assist with creating, updating and maintaining project trackers in EPIC. Provides support for document preparation. Attend internal study team meetings, and prepare and distribute study team agendas and minutes. etc.

Multiple positions. Position titles include but are not limited to Plant Engineer, Process Engineer, Project Engineer, Development Engineer, Automation and/or Control Engineer, and are available in manufacturing and development areas supporting: Bulk processing (Animal health products), facilities/utilities engineering, process development.

Verifies and keeps records on outgoing shipments and prepares items for shipment. Receives product and inspects items to ensure conformance to specifications. Duties include: Confirming shipped/received products/packages.

We have an opening for a talented Associate Scientist to join the ImmunoOncology platform at EMD Serono, Billerica, MA. The successful candidate will support the discovery of novel cancer immunotherapies. In his/her role, the candidate is expected to develop and conduct cellular immune assays to characterize small molecules or biologics that modulate the tumor immune environment and enhance the anti-tumor immune response.

Execute tasks per cGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing qualification block training program. Actively incorporate the Core Values set out by Emergent BioSolutions while performing day to day activities. Maintain state of facility environmental control including: preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing surfaces and equipment per Standard Operating Procedures. etc.

The Analyst I position will design and prepare all protocols and reports related to novel and diverse validation activities. The candidate will focus on Equipment, Utilities, and Software Validation. Responsibilities include: Write and execute validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of new and existing processes, equipment, systems, etc. Write summary reports, following good documentation practices. Use Kaye Validator, DataTrace dataloggers, and/or Veriteq dataloggers to perform mapping studies. Analyze statistical data to verify acceptable criteria. etc.

Responsibilities as an assistant manufacturing associate include: Execute tasks per cGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing qualification block training program. Actively incorporate the Core Values set out by Emergent BioSolutions while performing day to day activities.

The Analyst II, QC Microbiology position supports the Quality Control group at Emergent BioSolutions Camden Campus to maintain process optimization and manufacturing activities. The Microbiologist is responsible for performing activities in support of the Microbiology, Environmental Monitoring, and Utility testing programs, which includes microbiological product testing, monitoring of the manufacturing production space, and supporting quality initiatives. The individual routinely conducts monitoring, testing, and SOP generation and revision.

The right candidate must be organized and calm under pressure. Excellent communication skills are essential for this role for external interactions. This position requires a professional demeanor and a high level of discretion in regards to handling of confidential company information. Must enjoy a “start-up” atmosphere and be flexible, show initiative, good judgment and be willing to take on additional tasks and responsibilities as needed to achieve goals and deliverables. Must have strong knowledge of Microsoft Office (Outlook, Excel, Word, PowerPoint)

The Manufacturing Associate I – Fermentation works in a hands-on capacity in the cGMP fermentation and production support areas to manufacture Collagenase Clostridium Histolyticum (CCH) bulk drug substance (BDS). This role is responsible for supporting necessary fermentation and production activities, including validation and development work as needed.

Responsible for all aspects of validation, sample analysis and data preparation in support of pre-clinical and clinical studies. Ensure all work is conducted in accordance to GLP/GCP regulations. Conduct validation and sample analysis as per study method, in life study plan and or analytical/validation plans and SOPs in accordance to GLP/GCP. Promptly prepare and submit results after analysis. Work as a team and as directed by Study Managers and Lab Managers. Provide status reports on projects and accountable for meeting agreed timelines and performance quality. etc.

Several shifts avalible. The Medical Technologist will perform qualitative and quantitative tests and examinations using various analyzers and/or manual methods on specimen sources such as blood, urine, and other body fluids using established procedures. They will also be responsible for performing established quality assurance procedures (quality control testing, instrument function checks and calibrations). Maintains appropriate documentation and reports irregularities.

Duties include: performing routine biopharmaceutical characterization studies including UV/Vis, size exclusion, cation exchange chromatography. Support other methods such as mass spec, or immuno-based assays. Conduct experiments and record/interpretate data.

The Associate Scientist I position is an intermediate-level professional position involved in somewhat complex day-to-day activities in a laboratory setting under prescribed processes (protocols, standard operating procedures, methods, etc.). Responsibilities include completing work for research and development under CGMP and/or GLP guidelines for studies, documentation, etc. Assisting in conducting, monitoring and reporting studies to ensure data accuracy and report quality. Providing somewhat complex analytical work on projects and studies using a range of analytical techniques and instruments. Working with increasing independence on studies and assignments.

Responsibilities include: Execute experiements utilizing analytical methods to support preclinical pharamceutical product development. Use techniques/instrumentations such as HPLC and spectroscopy. Prepare test solutions, compounds, and reagents. Maintain lab instruments. etc.

2nd shift. Responsibilities include: manage all aspects of stability studies assigned by clients. Take responsibilities for quality and TAT of assigned studies. etc.

The purpose of this position is to perform laboratory processing of client orders; the majority of which will involve manual weighing and liquid handling of compounds. The position requires a highly motivated individual, able to work independently and as part of a team to ensure successful project support. This role will be expected to have increased understanding of Compound Management workflows, set forth SOPs, etc. Tasks will include, but are not limited to, performing the day to day laboratory work and direct communication with local and remote lab colleagues in a cross-functional environment.

The Risk Analyst will provide appropriate business risk assessments, identify areas of risk of loss, quantify the impact, develop and evaluate policies and provide guidance to the Company’s decision makers. The Risk Analyst is important role within the organization to minimize the impact of operational and financial risk to the enterprise.

Primary role is to perform all forms assembly activities including equipment setup and tear down where required as well as in-process verifications. In addition, this position includes several cross-functional responsibilities comprising Shipping, Receiving, Job Picking, Warehousing and Plant Cleaning and some Maintenance activities. This position also has responsibilities associated with Servicing returned products (disassembly and reassembly, diagnosis and report writing).

Candidates should love laboratory science and should enjoy technology innovation. You will work with a group of creative inventive scientists on developing novel state-of-the-art methods that are the basis for important new products to improve medical outcomes for patients with serious infections. Responsibilities include: developing experimental designs, preforming microbiological/molecular biological experiments, and other lab-related work.

Responsibilities as a research associate include: serving as a key member for testing, analyzing, and developing microfluidic devices. Integrate biochemical reactions in microfluidics. etc.

Responsibilities as a test engineer at Fluke iclude: plan/implement test systes for new product introductions. Support/maintain/improve test systems throughout factory. Advise design engineering of existing production capabilities. etc.

Duties include: develop and implement all quality-related processes and documentation. Direct manufacturing process development to meet quality metrics. Monitor faility performance and associated metrics. Etc.

Reports to manager, QC chemistry technical services. Responsibilities include: Method transfers/method verification/Co-Validations of compendial and non-compendial analytical methods utilized across Fresenius Kabi according to written procedures. Testing of routine and non-routine samples where specialized training is essential. etc.

Ensures that opportunities introduced are a strategic fit to the Lead Center. Coordinates costing activities with the Project Management Team. Ensures that all cost assumptions and cost drivers are optimized and technically feasible. Understands cost assumptions and challenges cost drivers where appropriate. Develops pricing and submits final quotes to the sales team. Establishes acceptable pricing for new business opportunities by optimizing minimum margin requirements and target pricing from the Business Development team. Leads quote meetings within the lead center and acts as the single point of contact at the Lead Center for the Commercial Team specific to the support of new business opportunities. Ensures that all quotations consider Lead Center resources, capabilities, profitability, strategic plan, and product liability and insurance concerns. Utilizes Salesforce.com as the single CRM (customer relationship management) tool for inputs and outputs to the quoting process. Measured by accuracy, clarity, and timeliness of quotation.

The Downstream Manufacturing Technician I will work directly with viral purification (either whole particle or split particle), continuous flow centrifuge operation, and sucrose gradient separation, techniques for filtration and chromatographic separation (i.e. column chromatography and HPLC) and viral inactivation.

Responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment; maintaining areas in high state of inspection preparedness, and utilizing business systems for inventory and process management. Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas:

HemoSonics, LLC is seeking an Associate Research Engineer who will be responsible for the support of concept phase activities, including ideation, feasibility testing, and early development of new product concepts; and the support of development activities. Key responsibilities include: Design and execute feasibility tests, Test, analyze, and interpret data and development situations/events requiring evaluation of identifiable factors, Apply standard principles, theories and concepts in the field and have working knowledge of other related disciplines, etc.

Applicants should have demonstrated team management skills as well as working knowledge of IATA sample shipment processes, CLIA-waivered laboratory processes, and ability to fully manage external vendors for our clinical trial testing needs. This position ensures the full reconciliation of all specimens submitted to outside client and vendors in a manner fully compliant to Good Clinical Practice under FDA guidelines. Responsibilities include: Completes all study procedures as per FDA regulations, GCP guidelines and protocol requirements, Assists with and performs laboratory procedures including sample check-in, preparation, centrifugation, storage and shipment, Assists with temperature monitoring and control of laboratory sample environments, etc.

Assist in conduct of clinical studies. Provides licensed nursing coverage for studies and performs procedures as allowed by training and delegation. Duties include: Assist in the conduct of clinical studies while providing licensed coverage. Performs all job responsibilities in accordance with standards of Good Clinical Practice (GCP), clinic standard operating procedures (SOP’s), and OSHA guidelines. Perform tasks such as EKG’s, vital signs, phlebotomy, insertion and maintenance of IV catheters. Communicates in a timely manner with physicians regarding patient safety concerns, adverse events, protocol deviations, and any study conduct issues.

Using company guidelines, the Filling Operator I is responsible for the full spectrum of duties in controlled filling and ancillary rooms. This may include but is not limited to: set-up, operation, sanitization, equipment cleaning, PM activities, airlock and ancillary room cleaning, etc. Assists with or performs preventive maintenance tasks on filling equipment, such as inspection and cleaning of machine parts, as may be required.

Perform functions within the Microbiology Laboratory and/or conduct critical microbiological analysis on test articles from all stages of the manufacturing process from incoming raw materials to finished goods. The duties also include equipment maintenance and LIMS management. Other responsibilities includes: Use sophisticated laboratory instruments and computer systems to collect and record data. Perform advanced laboratory assays requiring precise analytical and aseptic technique skills. Work on special projects and protocol testing that involves new methods and instrumentation. Complete all special projects and protocol testing in a timely and appropriate manner.

Perform functions within the Microbiology Laboratory and/or conduct critical microbiological analysis on test articles from all stages of the manufacturing process from incoming raw materials to finished goods. The duties also include equipment maintenance and LIMS management. Other responsibilities includes: Use sophisticated laboratory instruments and computer systems to collect and record data. Perform advanced laboratory assays requiring precise analytical and aseptic technique skills. Work on special projects and protocol testing that involves new methods and instrumentation. Complete all special projects and protocol testing in a timely and appropriate manner.

We are currently seeking an Operations Test Associate responsible for generating accurate and reliable data for biologic products or medical devices on stability. Responsibilities include: Performs routine stability testing using GMP/GLPpractices. Performs data analysis and results interpretationscomparing to stability protocol defined specifications, validity criteria, and alertlimits. Responsible for the maintenance and cleanliness ofthe laboratory, stocking shelves/drawers with testing materials. Prepares documents for storage in our documentmanagement system and manages original data files.

Responsible for the creation and transfer of manufacturing processes from R&D to Manufacturing and continuous improvement of existing processes.Essential Duties and Responsibilities The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Maintains the Pilot Plant laboratory under cGMP conditions. Produces development, pilot and production materials per written instructions, Completes ERP transactions, Stocks and maintains the laboratory supplies, Keeps accurate records and documentation, Completes laboratory work and associated paperwork by assigned completion dates, etc.

The Research Associate 2/3 will perform basic and advanced culture techniques, including microbiology, tissue culture and virus culture in support of assay development activities as well as product support activities. This includes sterile aerobic as well as anaerobic work technique and involves handling of infectious materials. Performs moderately complex experiments with input from supervisor. Understands experimental goal and exhibits critical thinking skillswhen evaluating data. Interprets experimental results in context of overall experimental goal, etc.

Responsible for the manufacture of GMP oligonucleotides; the continuous improvement of these existing oligo processes; and the development/transfer of new oligo processes.  Provides oligo process support to Operations group through instrument/oligo process troubleshooting and completion of NCR investigations.  Responsible for research, development and production manufacturing activities associated with oligos. Responsibilities include: Independently produces notebook, dev, pilot and production materials per written directions, Analyzes in-process and final oligos using state of the art analytical techniques, Troubleshoots simple manufacturing process problems, etc.

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Responsible for picking, packaging, and preparing product for shipment. Assists in loading trucks and running end-of -day reports for carriers. Works with other members of the Distribution Team to ensure all orders are prepared and shipped daily. Runs packing lists and prepares finished goods for shipment. etc.The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Responsible for picking, packaging, and preparing product for shipment. Assists in loading trucks and running end-of -day reports for carriers. Works with other members of the Distribution Team to ensure all orders are prepared and shipped daily. Runs packing lists and prepares finished goods for shipment. etc.The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Responsible for picking, packaging, and preparing product for shipment. Assists in loading trucks and running end-of -day reports for carriers. Works with other members of the Distribution Team to ensure all orders are prepared and shipped daily. Runs packing lists and prepares finished goods for shipment. etc.

We are currently seeking an Operations Test Associate responsible for generating accurate and reliable data for biologic products or medical devices on stability. Responsibilities include: Performs data analysis and results interpretations comparing to stability protocol defined specifications, validity criteria, and alert limits. Responsible for the maintenance and cleanliness of the laboratory, stocking shelves/drawers with testing materials. Responsible for the maintenance and cleanliness of equipment, calibrating or submitting items for calibration as needed. etc.

Homology Medicines is seeking a Research Associate to aid in operational support for methods to characterize AAV vector products. The individual in this role will be a talented and motivated technician who will focus on the analysis of research/development-grade vector samples using multiple AAV-specific analytical methods. This is a largely laboratory-based position with a focus on providing analytical support for characterizing research-grade vectors. Plans and executes AAV-specific characterization assays, including vector genome quantification by qPCR and ddPCR, viral capsid quantification by ELISA, protein analysis by SDS-Page gels, endotoxin testing and additional assays as needed

The Quality Control Analyst ensures all Quality Control (QC) activities at Hovione LLC are carried out in compliance with Corporate Operating Procedures (COP), Standard Operating Procedures (SOP), Internal Operating Procedures (IOP), and Federal Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Occupational Safety and Health Administration (OSHA), and Environmental Protection Agency (EPA) requirements. Responsibilities include: Perform analytical testing (i.e. raw materials, intermediates, API, stability, cleaning, method validation and cleaning) in a timely manner to meet deadlines; Execute qualification tests contained in protocols for equipment qualification; Perform instrument calibrations on Balances, High Pressure Liquid Chromatography (HPLC) and Gas Chromatography (GC); Carries out routine tasks, routine housekeeping related to the laboratory, and maintenance of analytical equipment.

The Process Engineer will ensure that the use of the best process engineering knowledge will be applied in scaling up chemical and spray drying projects to maximize customer satisfaction and Hovione’s interests and in compliance with all Federal, State, Local and internal policies. Main responsibilities include; Plan and design manufacturing processes based on chemical procedures to run safely and effectively in a pilot plant/kilo lab in accordance with the best known practices ensuring cGMP compliance. Contributes to the Process Hazard Analysis (PHA) of all processes under his/her responsibility and assures that all identified hazards are addressed prior to performing any activities within operations. Prepares Mass balance sheet, instructions for unit operations, production batch records, Bill of Materials and other GMP related documentation for all processes run in operations. etc.

The successful candidate will have responsibilities for reviewing and updating lab quality control processes, reviewing and analyzing results of tests to improve product quality level and maintaining product inventory. Tasks will include preparing product for internal and external customers and operation, maintenance and calibration of laboratory equipment. They will utilize standard procedures to formulate, test, fill and assemble product. Operates and maintains automated laboratory equipment, such as pipettors, scales, incubators, PCR/qPCR instruments and nucleic acid sequencers. Assembles reagents, kit orders, and other products for shipment to customers in accordance with standard protocols. Formulate reagents and solutions utilizing Standard Operating Procedures (SOP’s) and approved Work Instructions (WI’s). etc.

A Equipment Operator I is responsible for the safe and efficient operation of simple automated assembly machines. This individual will ensure the continued operation of assembly machines through interpretation of and appropriate response to machine faults and through infrequent alignment of stations and fixtures. This individual will perform simple, repetitive tasks associated with machine operation and will operate machines that require a low level of attentiveness. The operator is also responsible for ensuring that medical devices are assembled with the highest quality possible.

Technician will assist Manufacturing team in production of medical devices. Successful candidate will work within a high-energy, small, focused team environment and maintain a strong sense of shared responsibility and shared reward to make work fun and interesting. Work with Medical Device Production team in a moderate-volume commercial laboratory to fabricate polymeric films, perform and assist in daily laboratory tasks and work flow, maintain and edit standard operating procedures and work instructions, record data, write reports and communicate results. Ensure quality control of materials and end products of the company in a consistent manner.

As a Research Associate, you will be responsible for performing a variety of standard molecular biology techniques such as the extraction, isolation, and identification of biological molecules that are relevant to the generation of important clinical information using molecular methodologies such as polymerase chain reactions, real-time PCR, sequencing technologies, and standard or novel methodologies for protein detection.

As a Solid Phase Technician, you are responsible for performing manufacturing operations according to department procedures, specifications or work instructions and completing tasks within procedure/work-instruction-defined time frames. Specific duties include: Preparing reagents as bulk and for use in Manufacturing processes, Following appropriate control measures to prevent mixing of dissimilar solid phase components or products, Following applicable laboratory OSHA safety regulations with respect to chemical hazards, blood-borne pathogens, etc.

We are seeking a Laboratory Assistant for our Contract Research Laboratory who will perform immunology testing of client specimens collected from both pre-clinical and clinical studies using the following test methods: ELISPOT, ELISA, flow cytometry, etc. You will help support our quality improvement projects in conjunction with QA, support our quality system by data quality control, communicate with fellow laboratory personnel, maintain laboratory equipment, write reports, etc. All work is performed according to general laboratory safety standards, internal standard operating procedures (SOPs), client protocols, and applicable international, federal and state regulations.

The Clinical Specialist must provide the healthcare professional with the most current information pertaining to Indivior products and their approved indications in a manner which will ensure the appropriate use of these products and achieve the business potential of the territory. Responsibilities include: Invest the time and the effort to achieve the established goals for the territory such as sales, market share, doctor calls, appropriate program planning, etc. Plan and organize daily sales call activities to optimize the use of time and maximize the achievement of sales objectives.

The Clinical Specialist must provide the healthcare professional with the most current information pertaining to Indivior products and their approved indications in a manner which will ensure the appropriate use of these products and achieve the business potential of the territory. Responsibilities include: Invest the time and the effort to achieve the established goals for the territory such as sales, market share, doctor calls, appropriate program planning, etc. Plan and organize daily sales call activities to optimize the use of time and maximize the achievement of sales objectives.

This is an entry level position responsible for performing the QC functions for release of intermediate and finished products, including conducting stability studies, according to standard operating procedures. This position will assist in maintaining the work environment in state of compliance for GMP, OSHA and other applicable regulatory requirements. Performs QC testing/inspection of intermediate and finished products according to established house specifications accurately and on time. Inspects labels and finished components and kits to ensure compliance to all requirements before distribution. Assists with the maintenance and proper organization of the QC patient samples to ensure availability of the samples at all times and ease of retrieval.

The primary purpose of this position is to perform work which involves conventional engineering practice. Ensures Integer's internal and external customer expectations are met or exceeded. Accountabilities & Responsibilities: Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.

The primary purpose of this position is to develop competency in and performance basic assembly and/or inspection operations at Integer. The incumbent is expected to follow written procedures to meet production and quality requirements. Sets up equipment needed for assembly/inspection as per Manufacturing Process Instructions (MPI's) and Quality Work Instructions (QWI's). Understands own tasks and how they relate to others on their team. Works under close Supervision where duties are clearly defined. Will follow Standard Work where applicable. Assembles component parts as per print. Utilizes both manual and automatic machine operation.

Primary Purpose: To develop competency in and perform basic assembly and/or inspection operations at Integer. The incumbent is expected to follow written procedures to meet production and quality requirements. Responsibilities include: Set up equipment needed for assembly/inspection as per Manufacturing Process Instructions (MPI's) and Quality Work Instructions (QWI's). Assembles component parts as per print. Utilizes both manual and automatic machine operation. Visually and/or dimensionally inspects parts and/or completed assemblies for conformance to specifications. Identifies and escalates quality non-conformances.

The individual will be responsible for all material handling on 1st and 2nd shifts as well as aspects of receiving, shipping, inventory control and inventory movement. Other responsibilities include processing returned materials. Transact receipts, shipments, movements and work orders in a MRP system. Use department databases to track and manage Finished Goods and Raw Material Inventories. Effectively follow SOPs, policies and ISO/QSR requirements. etc.

We seek a Research Associate I, who will work with a dedicated group of scientists on the development and commercialization of biomedical technologies. Conduct laboratory research and support general R&D efforts for customer-based biomedical research. Projects may involve cell culture, virology, DNA preparation, and liquid-handling automation. Perform cell-based assays (Western blot, ELISA, immunofluorescence, flow cytometry)

The Production Scientist I synthesizes, purifies, formulates and ensures the quality of custom oligonucleotides according to the customer’s order and internal specifications. This generally includes, synthesis, cleavage, deprotection, purification, desalting, QC sampling, QC analysis and final packaging and formulation of the oligos and chemical reagents being made.

Job duties as a research associate include: Assemble study designs, perform laboratory experiments, organize data, and analyze results under minimal supervision. Set up and perform HPLC, as well as other assays, to characterize protein and peptide molecules. Analyzes, records, and reports the results and conclusions for laboratory experiments. Summarizes and interprets data. The candidate should also be open to learn new laboratory techniques and work under the guidance of experienced researchers.

Primary Function of Position: Install and support the Intuitive Surgical products and ensure service agreements and warranty obligations are fulfilled. Exceed customer expectations and maintain customer satisfaction to the highest possible level. Responsibilities includes: Pre site verifications to prepare site for system installation. Assist in coordination of system delivery (e.g. confirming site readiness) Troubleshoot and repair Intuitive Surgical products and associated equipment failures as required. etc.

The open associate scientist position is one that will support all in vivo, small animal medical imaging studies. These studies include nuclear medicine (PET/SPECT), computed tomography (CT), and magnetic resonance imaging (MRI). The Associate Scientist will maintain the animal and imaging facility, provide study support in mouse and rat disease models ranging from basic injections to surgical procedures, and assist in image acquisition procedures. This position will be an immersive cross-functional opportunity where an ideal candidate will identify areas in which to excel and focus a career in research. A qualified applicant is enthusiastic about biomedical research, able and willing to rapidly learn new skills and begin applying them immediately.

The Histology Laboratory Technician/Technologist will interface directly with laboratory personnel to drive the utmost quality and throughput of Invitae’s offering. Responsibilities include: Must perform clinical patient testing, assay validation testing and quality control testing along with applicable assay documentation according to all laboratory procedures under the direct supervision of a General and/or Technical Supervisor unless they too qualify for that position. Collaborate with research and development personnel in the development and optimization of new histology protocols and clinical assays. Responsible for following laboratory procedures and schedules for specimen handling and processing, test performance, analyses, and reporting and maintaining records of patient test results as well as all safety and compliance regulations

Under general supervision, provide hands on support to local end-users, to restore service and / or identify and correct core problem. Responsibilities include: Recreate user problems to resolve operating difficulties and recommend system modifications to reduce user problems. Escalate more complex problems to appropriate level of management and provide information on problems that are severe in nature or that are exceeding target dates. Adhere to established IT policies, procedures and standards and ensure conformance with information systems, goals and procedures. Provide creative, effective solutions and recommend procedures and resources to enhance efficiency, productivity, and end user satisfaction. etc.

Under the supervision of Manager medical lab, this role will be Perform gross trimming of tissues and organs systems, processing, paraffin embedding, and sectioning for pathological analysis in our pathology laboratory. According to policies and procedures, perform routine and non-routine activities involved in the preparation of slides, for microscopic evaluation by pathologist(s). Secure the slice sample on a slide and use specialized dyes to stain it, bringing out cellular structures and allowing pathologists, or research scientists to identify abnormal cells and monitor cell function.

This role will primarily focus on outbound initiatives including research and evaluation of various health care systems, identifying key medical and administrative contacts, competitive intelligence gathering, and appointment setting. A successful Sales Associate will enjoy making outbound calls to educate medical professionals about iRhythm products and services.

Essential functions include: Thoroughly assess any problems with the process equipment, identifies the problems, makes necessary repairs and completes all associated GMP documentation required to appropriately record the work performed in order to minimize equipment downtime. Participates in cross functional teams to identify assignable root causes for any product or equipment related deviations or anomalies, establish and implement necessary corrective and preventive actions needed to ensure the incident or anomaly is prevented in the future. Coordinates routine and non-routine maintenance within the master production schedule, work closely with manufacturing personnel to obtain information needed to assess equipment problems in a courteous professional demeanor, as well as working with other Maintenance Technicians.

We are looking for a someone to join a fast-paced, collaborative, and multidisciplinary team to provide QC analysis of raw material, in-process and drug substance testing in support of our GMP operations. The successful candidate will have some experience in analytical chemistry. Experience with chromatography and ELISA techniques is a plus. The ideal candidate has a high attention to detail, is organized in their work and works well independently and in teams. Perform QC analytical testing in support of the GMP manufacturing schedule and drug substance release

This is a position in the Downstream Process Development group involving the planning and execution of purification pilot/scale up and lab-scale confirmation runs for biological therapeutics using chromatography, precipitation, and filtration methods. Duties include: Use of AKTA chromatography systems with Unicorn 7 software. Use of pumps for normal and tangential flow filtration operations. Use of pH and conductivity meters. Assist in the evaluation, development and implementation of new downstream. technologies leading to process improvements and efficiency of operation. etc.

Responsible for quality computer system administration, providing technical/end user support for quality computer system, and maintaining close communication with management to keep stakeholders apprised of quality computer system incidents/ resolutions, project validation status, and other relevant issues. The role requires leading and/or assisting in quality computer system validation efforts and ensuring all work is carried out in compliance with cGMPs, company policies and procedures, 21 CFR Part 11, EU Annex 11, ICH guidelines, and other applicable industry regulations.

Perform data review for contract services projects, including analytical and formulations programs for monoclonal antibodies, recombinant proteins, peptides, and small molecules in a variety of dosage form such as liquids and lyophilized powders and suspensions for injection, topical gels, and other novel delivery systems. Perform timely review of cGMP data from HPLC, ELISA, CE, etc. with a high focus on data quality and integrity to ensure accuracy, completeness, and compliance.

Responsible for executing and managing method transfer, method development, and/or qualification of test methods to be used for process characterization testing. Responsible for executing assays in support of process characterization studies. Responsible performing elementary data analysis and reporting of results to corresponding internal departments. Familiar with protein characterization technologies such as: HPLC, ELISA, and UV-Vis. Familiarity with automated analysis technologies such as TECAN, BioTek, or similar automated liquid handling platforms.Responsible for executing and managing method transfer, method development, and/or qualification of test methods to be used for process characterization testing. Responsible for executing assays in support of process characterization studies. Responsible performing elementary data analysis and reporting of results to corresponding internal departments. Familiar with protein characterization technologies such as: HPLC, ELISA, and UV-Vis. Familiarity with automated analysis technologies such as TECAN, BioTek, or similar automated liquid handling platforms.

Essential job duties include: Assist in designing experiments to develop and manufacture custom specialty products. Set up and conduct chemical experiments, tests, and analyses using techniques such as spectroscopy, chromatography, physical and chemical extractions, dynamic and quasi-electric light scattering and microscopy. Compile and interpret results of tests and analyses Prepare graphs and charts to document experimental results for presentation to management.

The successful applicant will use their cell and molecular biology understanding to support the development of autologous T cell transfer therapies. Responsibilities include: Perform supervisor-guided cell and molecular biology experiments in the lab. Contribute to the development and characterization of genetically engineered cancer cell lines, and primary immune cells. Support process development efforts for KSQ’s autologous T cell transfer therapy programs. Document, and communicate experimental design and data

The QC Data Review Specialist will be responsible for GMP review and comment on laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GMP standards

Operators are responsible for operating special purpose machines or industrial equipment to specifications on production basis in typical oral solid dose pharmaceutical manufacturing. Processes include dispensing and weighing of materials, using automatic and semi-automatic equipment for tablet manufacturing, combining materials to make blends and solutions, and packaging of finished product.

Responsibilities include: Performs all paperwork, technical, and non-technical procedures required to process and submit specimens. Assigns specific computer generated identification numbers, checks for accuracy, and records all items processed. Forwards accessioned specimens to designated laboratory location(s); and locating and correcting any discrepancies. Learns and keeps familiar with lab procedures and location of stored specimens.

Job Duties/Responsibilities: Prepare laboratory specimens for analysis and testing. Unpack and route specimens to their respective staging areas. Accurately Identify and label specimens. Pack and ship specimens to proper testing facilities. Meet department activity and production goals.

Performs all technical duties related to the production of histo-pathological slides including embedding, microtomy, special stains, and IHC staining. 2nd shift.

Performs a variety of laboratory tests and assays in accordance with established policies, procedures and regulations in a designated technical department. nterprets results, subject to verification by Technologist/Supervisor, and providing allowance by State regulations.

PST meets minimum requirements and experience for client office and roving (with limited locations) positions, and patient service centers offering minimal services. Skill and comprehension level required for this category: Phlebotomy certification (where required) from an accredited agency, completion of an approved phlebotomy training course, or a minimum of one year verifiable phlebotomy experience. Exhibit proficiency in blood collection by venipuncture and capillary technique from patients of all age groups, and urine drug screen collections. Able to grasp a firm understanding of the importance of compliance and safety as outlined during new hire orientation and annual training.

Responsibilities include but are not limited to: Routine work in a BSC. Working knowledge and use of micropipettes. Exposure to HPLC a plus. Exposure to IEF. Familiar with SDS page. Etc.

The objective of this position is to perform operations within the Finishing Operations Team to support the manufacture of radioactive products in a timely and compliant manner based on business needs. Incumbent ensures that the integrity and quality of the products produced comply with the associated operating procedures to meet all cGMP, regulatory, and safety requirements. This position may require mandatory overtime, as needed, supporting finishing operations on holidays, weekends, and/or late and early production shifts.

LATITUDE is seeking a Research Associate to carry out individual drug formulation development projects for our clients. LATITUDE utilizes its extensive experience and proprietary technologies to solve issues of insolubility, instability, poor absorption and other formulation challenges over a range of dosage forms for both external clients and internal programs. A successful candidate will possess proficiency in a variety of analytical chemistry techniques including HPLC. This is a salaried, full-time position at our San Diego location.

This position requires an individual with strong problem solving skills, good laboratory technique, and the ability to execute complex experiments. The successful candidate will have a desire to learn and the strong attention to detail. This position will entail running of automated oligonucleotide synthesizers as well as synthetic chemistry and/or molecular biology laboratory work to support new product development.

The Regulatory Affairs and Product Support Associate will proactively support, along with other members of the organization, projects and regulatory submissions for Lifecore customers and their products. They will assist with or lead preparation and maintenance of required regulatory submissions, such as Drug Master Files (DMF), Device Master Files (MAF), design dossiers, change notifications, technical files, etc.; assist with maintenance of Master File database; provide regulatory support to Lifecore customers as necessary; assist or lead complaint handling and MDR/vigilance activities; review and approve change orders and CATSweb actions; review internal change requests to ensure regulatory compliance and good quality assurance practices; assist in compiling, formatting and maintaining documentation for domestic and international product registrations, including making copies and filing; participate in FDA, ISO and Client Audits.

LifeMine is seeking a motivated Research Associate to be an integral member of the Biochemistry team responsible for discovering and developing fungal derived drugs to targets of exceptional therapeutic value. Responsibilities include: Perform enzymatic and protein-protein interaction assays for multiple targets. Execute routine screening assays. Present results at group and/or project meetings. Maintain and track an inventory of biochemical reagents.

The Corporate Development Associate reports to the Senior Director, Corporate Development and Investor Relations and supports all aspects of Ligand’s corporate development (M&A) and general strategy functions with significant exposure to senior corporate leadership. Responsibilities include: mergers & acquisitions (Perform financial valuation and other qualitative analysis on target acquisition candidates, Assist and creation of presentation materials for senior management and Board of Directors review, Monitor market conditions, evaluate companies and/or assets and maintain potential deal list, etc.)

The candidate will be a key member of an entry level, interactive technical service team that acts as the front line of communications between customers and our technical service specialists.  This team is focused on providing best-in-class customer support via telephone, email and internet.  The candidate is responsible for fielding basic technical inquiries on MilliporeSigma's products and navigating more advanced technical inquiries to the appropriate specialist within the organization. Our customer base includes Pharmaceutical and Biotech companies, Universities, Hospitals and Government agencies.  Professional communication and schedule flexibility are imperative.

Under close supervision, the Production Associate participates in entry-level production duties such as filling, labeling, packaging, shipping and other duties as assigned in a laboratory/manufacturing environment. Essential duties include: filling, labeling, packaging, etc.

The Protein Science / Buffer-media prep and QC group is a core function of the Protein and Cell Sciences (PCS) department that supports both early and late stage discovery projects and seeking a QC Research Associate. Responsible for small to large scale media and buffer production, as well as QC analytics supporting GLP tox drug substance production. Responsible for media / buffer preparation, equipment maintenance and calibration, data analysis, electronic lab notebook and batch record documentation. Responsible for media and buffer preparation to meet GLP tox protein production and reference run schedules, which includes raw material and chemical procurement and inventory control.

Essential job functions include: Performs IHC, ELISA, and any other relevant tests as needed to conduct product development testing. Assists with establishing, maintaining, and updating the Design History Files (DHF) for new and/or existing products. Performs published literature reviews. Identifies and documents published clones, published protocols, etc as required.Provides technical support on developing new and improving existing IHC reagent processes and products. Conducts organized development testing to generate support data for new potential products or changes to current products.

Evaluate stable isotope products according to established protocols, provide technical support to others and perform operations in support of the group and department. Essential job functions include: Perform multi-disciplined, established assays and/or unit operations, involving stable isotope compounds. Ensure all applicable log books have been filled out completely as required by current procedures. Perform routine troubleshooting and miscellaneous duties or tasks as necessary. In compliance with change control procedures, improve processes through application of scientific knowledge, experience, and principles.

(Two openings) These positions are responsible for participating as team members in a laboratory environment for finished product/or development programs focused on the goal of testing and releasing the immunoassays found in Micropoint's in-vitro diagnostic products for point-of-care (POC) testing. Responsibilities include: Work with QA/QC manager to test, characterize and release quantitative immunoassays to meet both FDA and EU regulatory requirements for diagnostic IVD applications, Assist the R&D team in the POC product development including feasibility, verification and validation, manufacturing transfer and commercialization

This 24-month rotational program is designed to train new Engineers on various aspects of MicroVention - Terumo technology, procedures, and processes.  All candidates will be assigned a Mentor, as well as an Advisor to oversee their program succession, and will be provided with additional classroom training.  Successful candidates will have three (3) eight-month rotations.  These rotations include one (1) required rotation and two (2) optional rotation. The Engineer I (EIT) supports development of medical device products with work including writing or verifying specifications, designing new products, fixtures, test processes, equipment and specifying raw materials to ensure the concepts and/or prototypes meet their requirements. Typical job duties might include: Developing new product concepts and products. Engineering design and process development. Generating intellectual property and writing invention disclosures.This 24-month rotational program is designed to train new Engineers on various aspects of MicroVention - Terumo technology, procedures, and processes.  All candidates will be assigned a Mentor, as well as an Advisor to oversee their program succession, and will be provided with additional classroom training.  Successful candidates will have three (3) eight-month rotations.  These rotations include one (1) required rotation and two (2) optional rotation. The Engineer I (EIT) supports development of medical device products with work including writing or verifying specifications, designing new products, fixtures, test processes, equipment and specifying raw materials to ensure the concepts and/or prototypes meet their requirements. Typical job duties might inc

The Regulatory Affairs Associate/Regulatory Affairs Specialist is in a high-visibility, high-recognition role and will be responsible for obtaining regulatory approvals, and ensures compliance to China-specific regulatory agency requirements. Job duties: Executes regulatory requirements for China. Reviews and files worldwide regulatory submissions (dossiers/ technical files / STED) to ensure MicroVention devices are commercially available in international markets based on the organization’s objectives. Reviews and files China submissions (JV & MV). Communicates with regulatory agencies on administrative and routine matters.

The Associate I (ASI) will perform safety testing required to manufacture clinical and commercial products. The ASI is required to make scientific observations, maintain detailed workbooks/documentation and ensure all documentation fulfills generally accepted professional/industry standards. Additionally, they are required to maintain a thorough understanding of BioReliance services, technical principles and applications.

Manufacture or evaluate products according to established protocols, provide technical support to others and perform operations in support of the group and department. Essential functions include: ensure quality through process, perform routine assays/processes and/or unit operations, complete work volume, stay in compliance with change control procedures, improve processes, etc.

The unique duties of this position will primarily consist of manufacturing primary human cells including activities that involve graft engineering for cellular therapies as well as supporting the development of scalable cell culture processes. Furthermore, you will be responsible for completing successful qualifications and ongoing support procedures for clean room operations and assisting in the development, writing, and review of SOPs, material specifications, standard manufacturing procedures, batch records and other GMP documentation.

Provide support managing the Samples and Marketing Materials for the Mission salesforce teams. Assist with coordinating shipment orders with the Distribution Centers on a weekly basis. Coordinate and maintain items in Sales force Ordering system on daily basis. Maintain the Sales Incentive reward program for the sales force. Provide sales reports for samples and marketing materials to the marketing teams and Outside Marketing Resources, when requested, usually monthly. Provide Sales Reports to Department Supervisor when necessary. Maintain inventory of samples and training materials for the new hire training. On a quarterly basis, pack and ship new hire training materials to and from the training location, as required.

The individual in this role will perform cGMP QC testing for QC Chemistry, release and stability.   Also, this individual may support special projects as assigned. The shift for this role will be a 4 days a week for 10 hours a day (4X10) on either Sunday-Wednesday or Wednesday -Saturday.

Essential duties and responsibilities include: Purification of a wide variety of cardiac muscle proteins using various chromatographic techniques, Carry out multiple experiments in parallel and keep detailed, meticulous notes, Analyze and report experimental results, both in daily updates, regular database inputs, and in final reports, Execute all methods and techniques required to purify soluble and secreted proteins including the ӒKTA PURE FPLC platform, SDS-PAGE, TFF, microfluidizer, plate-based assays, spectrophotometry, and HPLC

The Manufacturing Research Associate I is responsible for supporting the production of reagents used in nCounter Analysis Systems. The role requires learning and performing both manual and automated production processes for the manufacture of raw, intermediate, and final reagents needed for the multiplexed detection and quantification of many different types of target molecules from biological samples. This individual learns to use professional concepts and apply company policies and procedures to resolve routine issues, in addition to acquiring the skills to use equipment, perform SOPs, use Document Control systems, ERP systems, etc.

Weekend and On-Call Position. Responsibilities and duties include: Process and key-in prescriptions with accuracy, attention to detail, and efficiency. Correctly input sensitive prescription information into computer system, dispense correct medication, and verify information before releasing prescriptions. Demonstrate knowledge of Third Party insurances and billing procedures. Proactively partner with the Pharmacy, Operations and Engineering teams to address issues and achieve high quality and throughput in fast-growing, technology-empowered pharmacy.

The individual in this position will support product development and lead test-related activities related to the development of NxStage Medical’s equipment and disposable products. Responsibilities include: Work closely with all engineering disciplines, including Systems, Electrical, Mechanical, Disposables, and Software Engineering, as well as Project Management and Quality personnel, to verify and validate product designs. Participate in the planning and lead the execution of Validation & Verification (V&V) testing activities in support of regulatory filings for Class II medical devices. Specify, design, and develop test systems (hardware & software); ensure that all test systems and equipment are appropriately validated and controlled. Manage V&V documentation, including derivation of Test Procedures from System and Sub-System Specifications, validation of Test Procedures and Test Fixtures, and generation of test reports.

This position will assist production related activities in the cGMP Manufacturing Core according to established procedures at the Medical Counter Measures (MCMs) Advanced Development and Manufacturing Facility in Alachua (Florida). Responsibilities include: Perform and/or assist with upstream related activities including Cell culture at small and large scale, Cell transfection, Media and buffer preparation, Bioreactor and Fermentor based production. Draft Standard Operation Procedures, Change Control, Deviations. Write raw material specifications, research, source and order material and lab wares. Perform activities to support production campaign such as preparation of tubing assemblies, autoclave, material request and transfer into production room.

As a Mechanical Engineer II on the Engineering Services team, you will be empowered and inspired to do your best work. You will contribute to our mission by helping to support new product introduction and improve existing and new XRF and XRD products that help make the world a safer place. In your role, you will help to improve efficiencies on the production floor by working with Production Engineering in the design and documentation of production fixtures and tooling. In a typical day, you will: Design production fixtures and tooling. Translate concepts to final designs and documentation complete with Bills of Material. Resolve product/process problems, support development of new products/processes, initiate technical investigations, and prepare design specifications, analyses, and make recommendations for presentation and approval.

The Production Test Technician II will perform the set-up, calibration, testing and troubleshooting of circuits, components, instruments and mechanical assemblies. Follow methods and procedures from drawings, diagrams and test plans. May complete rework on assemblies and / or systems as a result of testing. Job duties include: Adhere to policy and procedures to maintain a safe and clean work environment. Apply acquired job skills, company policies and procedures to complete assigned tasks and adherence to production plan schedules while producing high quality products to standards. Advise management of adverse manufacturing and/or equipment conditions and issues that are affecting production and /or safety.

This role works closely and collaborates with the field sales and internal team members to provide the best patient experience possible. This role is responsible for communicating insurance benefit guidelines and cost share information with patients and assists them with their decisions regarding insulin pump therapy. Promote and sell Insulet’s products to prospective customers. Responsible for making outbound calls to patients who have expressed interest in the OmniPod System. Responsible for handling inbound calls from patients generated through physicians’ offices or marketing programs.

Responsibilities include: Involves multiple de novo R/D projects for antibodyand assay products development.Performsvalidation tests on variant sera or antibody samples. Participates other duties such as antibody production, purification and conjugation. Records experiment procedure and results in notebooks and computer accurately. etc

Entry level engineering position responsible for supporting projects lead by more senior engineers. Responsibilities include: developing CAD models/drawings, authoring test protocols and reports, performs product testing, etc.

The Analytical Chemist is responsible for testing of raw materials, in-process materials, and finished products to support release and stability programs. Perform laboratory tests such as sample extractions, set up and execution of chromatographic methods (HPLC and GC), and dissolution testing. Develops and executes UV, IR and PSD measurements and wet techniques as applied in the Pharmaceutical Analysis/Testing of products and excipients. Executes components of method validation and method transfer projects.

The purpose of this position is to assist in the scale up of manufacturing processes for new DepoFOAM formulations and the development of analytical methods to characterize materials for those efforts. Responsibilities include: Provide technical and analytical assistance to support new product development and process scale-up. Perform hands on work to set-up and execute experiments on bench-top, lab, and pilot scale manufacturing equipment. Support the technology-transfer of processes to the pilot and commercial scales to produce material for pre-clinical evaluation and clinical trials. Execute analytical methods for in-process and product material characterization, performing physical and chemical stability studies as needed. Maintain good working knowledge of the use, maintenance and repair of laboratory and manufacturing equipment.

The Quality Associate II, Document Control follows the applicable Document Control SOPs and requirements in order to maintain a controlled environment within Document Control. This role, which is customer service oriented, works with various departments to either retrieve completed documents or generate new documents. Works in more complex areas of Document Control including APR documents, the Electronic Document Management System (EDMS), and management of documents during regulatory inspections. Provides guidance to the Document Control staff. Trains Quality Associate I, Document Control. Works with the team in maintaining a collaborative environment.

This role is responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing to support Phase I/II/III and Commercial GMP manufacturing. Key responsibilities include but are not limited to: Perform Environmental Monitoring of Grade B-D Cleanrooms, including sampling of viable surfaces, viable air and non-viable particulates in a Phase I/II/III/Commercial GMP Manufacturing facility. Conducts routine sampling and testing of Clean Utilities such as USP water (WFI) and clean steam. Conducts bioburden testing on prepared buffers/solutions, equipment cleaning samples, in-process and release drug product samples. Ability to isolate and sub-culture microorganisms for identification.

The Drug Safety Specialist will provide technical and process-related support to drug safety management (clinical trials) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). Daily tasks include: Triage incoming reports for completeness, legibility and validity. Electronic documentation and quality control of drug safety information. Data entry of case reports into safety database / tracking system.

The main functions of a Process Engineer are focused around two key activities of the production area: identifying and mitigating packaging issues for existing business through strong engineering and process improvement methods, and designing and supporting packaging processes for new business. Both activities are focused around technical and operational support to the production, maintenance, and support staffs in the areas of process improvement, equipment modification and optimization, safety and quality improvement, and increasing throughput. This is achieved through individual effort and facilitation of teams, tracking and analysis metrics, strong understanding and utilization of good engineering practices, project management, and the use of Lean Six Sigma techniques.

As a Quality Engineer at Penumbra, you will participate in all aspects of product development, supplier development and manufacturing in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. Responsibilities include: Represent Quality Engineering on New Product Development (NPD) cross-functional teams, interfacing among multiple departments and teams such as Manufacturing, QC, R&D, Regulatory Affairs, Operations/Planning, and Marketing. Troubleshoot, update, and improve difficult manufacturing processes for assigned product lines.

Responsibilities include: microbiology (aerobic plate counts, probable number analysis, isolating/identifying bacterial cultures, ELISA, PCR, etc.) and routine lab functions (data entry, maintaining bacterial control cultures, instrument maintenance, etc.)

We are looking for a team-oriented Laboratory Assistant to join our operations team. The ideal individual must have the ability to think on their feet and troubleshoot issues. Responsibilities include: Adhere to the laboratory's quality control policies. Participate in laboratory support work as required by the team needs and at the direction of laboratory management. Following the laboratory’s procedures for specimen handling, receipt and data entry into the lab information management system (LIMS). Maintain lab equipment. Etc.

The qualified individual will be responsible for becoming proficient in a breadth of analytical methodologies including real-time PCR, HPLC, cell-based assays, and other relevant biochemical analysis methods.  The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team.  The candidate must thrive in a fast-paced, matrixed environment.  Attention to detail, strong organizational skills, and effective interpersonal and communication skills are required. Ability to document analytical results in regulated systems and technical reports is also required.

The Clinical Project Assistant (CPA) provides support to the clinical study teams in the execution of clinical trials.  Under the direction of the Clinical Project Associate, CTM or Study Lead, the CPA’s primary responsibilities include maintaining Trial Master File (TMF) and Clinical Trial Management System (CTMS) in an inspection-ready state, assisting with site management, initiating collection of and reviewing and tracking essential documents throughout the life of the trial. This role contributes to the production and distribution of study materials and site/study communications.

Physical Sciences Inc., with offices located in Andover and Wilmington, is looking for an entry level Scientist to support advanced Lithium ion battery research and development programs at its Wilmington facility. The individual will be involved in day-to-day hands-on laboratory experimentation, data collection, and analysis. The responsibilities for this position include: battery scientist, assist in the development of advanced anode, cathode, separator and electrolyte components for next generation Li-ion batteries, perform routine lab operations including preparing electrode slurries and building cells for electrochemical evaluation, collect, analyze and present data and findings in informal and formal reports, follow safety procedures and prepare standard operating procedures for new processes developed.

We make platelets. We have developed and patented a microfluidic bioreactor and shown that functional platelets can be generated from human induced pluripotent stem cell cultures. We are now scaling platelet production for human clinical trials and leveraging our platelet platform for cell-based drug delivery. The successful Research Associate will join our Designer Platelet Team, working directly on optimizing and characterizing our drug delivery platform, and providing support for ongoing and emerging research projects. The ideal candidate has experience with platelets, pluripotent stem cells, genetic engineering and enjoys working with a team of scientists in a fast-paced and highly matrix environment. etc.

PMI Biopharma Solutions is looking for an Analytical Development team member that is passionate and driven regarding his/her work. PMI Biopharma Solutions desires a team member eager to work in an environment where people are motivated to do their best for the company and its clients. The Chemist I position, reporting to the Director, Analytical Development, will operate under moderate supervision to perform chemical analyses of samples according to standardized procedures to determine the identity, content, purity, stability, and other characteristics of the samples analyzed. He/she may perform method development activities related to the development of methods for testing of raw materials and clinical drug product as well as formulation development. etc.

PMI Biopharma Solutions is looking for an Analytical Development team member that is passionate and driven regarding his/her work. PMI Biopharma Solutions desires a team member eager to work in an environment where people are motivated to do their best for the company and its clients. Reporting to the Microbiology Supervisor, the Microbiologist I will be responsible for performing environmental monitoring sampling of ISO class environments and assisting with preparation, characterization, and identification of environmental isolates. He/she will perform raw material and drug product method development and cGMP testing. etc.

PolarityTE is seeking a motivated, responsible, and self-sufficient individual to help support the everyday tasks of the Clinical Trials department. Responsibilities will span multiple trials and indications. Key responsibilities include: Manage the organization of trial files and critical documents. Support clinical trials team with shipments, equipment tracking and management, and supply inventory. Maintain clinical trial metrics and patient enrollment activities for weekly and monthly meetings. etc.

The Temporary Clinical Data Manager will support the Data Management group from study start-up through database lock and clinical study report. The successful candidate will deliver high quality data, on time and on budget. In this role, the candidate will be expected to lead and provide oversight for the execution of data management activities for more than one compound in a therapeutic area. This role will report to the Associate Director, Clinical Data Management. Works collaboratively with Clinical Programmers, Statistical Programmers, Biostatisticians, Clinical Research, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for moderately complex clinical data acquisition, quality checking and reporting. etc.

The Development Associate will be a key member of a dynamic team that develops and implements characterization strategies to support and enable process and clinical development of gene-engineered cell products. This is a lab-based position that will involve hands-on development of clinical manufacturing processes for selecting, gene-modifying and growing T cell subsets. This position will interface with our Research and Development team as well as with outside Contract Manufacturing Organizations. The ideal candidate will be skilled in T cell culture techniques, flow cytometry and have experience working in or supporting cGMP manufacturing projects. The candidate will have good oral and written communication skills, and will work with minimal supervision to design experiments, manage projects, collect data, and prepare reports.

As an Associate Scientist, you will use state-of-the-art technologies to perform high-quality sample testing for key pharmaceutical clients across the industry. Your sample preparation and sample analysis serves as an integral piece in helping PPD accomplish our goal of helping bring life-changing therapies to market. In this position you will perform a variety of validated or experimental analytical procedures such as ELISA. You love science and have keen observation skills. You are a self-directed learner with excellent attention to detail. You have an inherent scientific curiosity and enjoy working with instrumentation. etc.

We are seeking a passionate, highly organized, sharp individual seeking to begin a career in Operations in a lab setting. As an Associate Scientist/Lab Ops Tech you will perform a variety of tasks such as arranging supplies and supporting the Immunohistochemistry, Pathology and Histology in the Translational Medicine group. Your role will strictly be laboratory operations, and not include any bench work. You, as the Associate Scientist will assist scientists through tasks such as shipping and receiving, reagent and supply ordering, inventorying and stocking, lab cleanliness, safety, setting up equipment service & maintenance and record keeping for the labs. etc.

As associate QC reviewer you will be responsible for: Ensures the quality of laboratory data and reports. Reviews chromatographic data and related notebooks as specified by Standard Operating Procedures (SOPs). Evaluates data to ensure compliance with analytical methods, client criteria, Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)

Responsibilities include: Audits laboratory data for compliance with methods and standard operating procedures and report findings. Audits sample result tables and analytical reports for completeness and accurate representation of the data and report findings. Assists in the preparation of audit findings and/or other related information. Serves as a resource to operational departments on audit or quality assurance subject matter

Responsibilities as an Assistnat Scientist - HPLC include: Possesses an understanding of laboratory procedures and under general supervision can conduct complex analysis. Performs a variety of routine sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing. Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory guidelines.

The Medical Technologist independently and without technical supervision performs low, moderate, and high complexity clinical laboratory testing as a generalist, with assignment in some or all of the following disciplines: urinalysis, coagulation, hematology, chemistry, special chemistry, and immunology. The Med Tech also troubleshoots laboratory equipment and methods and provides technical supervision of others as required.

Responsibilities include: Provdies regulatory expertise/guidance for development and submission of US labeling components. Controls consistency of US labeling content through alignmnet with the core documents across product families and with all applicable best practicies. Must have a basic understanding of the drug development process and knowledge of the pertaining regulations

As a clinical trials specialist, you are the primary point of contact/liaison for the sites. Sponsor internal stakeholders during study life cycle. Preform investigative site recruitment/feasibility, essential document collection and review, maintenance and close-out in-house site management activities in accordance with the Sponsor and/or PRA protocol. In addition, you will create and distribute meeting agendas and take meeting minutes during internal and sponsor calls, roll out training plans to team members and provide access to project systems.

The Lab Associate is part of the operational team within the sample preparation alb. The Lab Associate ensure the appropriate collection, processing, storage and shipment of samples. Daily tasks may inolve maintenance of equipment, processing and shipment of samples. The Lab Associate is part of the study team that is responsible for the execution of the study. \

Precision BioSciences is seeking a detail oriented molecular biologist with recent laboratory experience for a Research Assistant position. The position will be responsible for routine cloning, DNA preparation and manipulation of bacterial and mammalian cells. The candidate must be a fast learner, meticulous and have a track record of successful bench work. The position is working closely with a large, friendly team in a fast-paced, collaborative environment. As a member of the Core Technology team, the Research Assistant will be responsible for: cloning a variety of constructs into plasmid DNA, plasmid DNA purification, genomic DNA purification, PCR, generation of electrocompotent bacteria. etc.

The Research Associate, Cell Therapy Bioanalytics works within the Cell Therapy Development Team and participates in providing bioanalytical support for Cell Therapy Process Development projects. The position will contribute to Bioanalytics development efforts for CART-cell projects by providing sample preparation and analysis in a timely manner. This position is lab-based and will share facilities and resources with the Cell Therapy teams. Daily responsibilities include: Execute bioanalytical methods for in-process sample analysis and cell product testing, Analyze generated data according to established SOPs and report results of analysis to Cell Therapy Team Leaders in a timely manner, Coordinate with Scientists, Research Assistants, and Research Associates to plan and carry out experiments for developing T Cell Therapies.

As the primary “storyteller” for your assigned brands, the copywriter partners with senior writers as well as creative leaders to properly understand, articulate and develop copy. Working in a wide variety of mediums, including but not limited to print, collateral, video, digital, etc., you will ensure our content is consistent with the established strategy, brand guidelines, and industry standards. You’ll: Participating in the creation of the brand narrative, from the ground-up. Presenting creative to clients and core constituents. Engaging in productive dialogue as it pertains to brand strategy, narrative arch, and copy to ensure alignment; real-time as necessary with both internal and client teams. Participate in all concepting sessions; taking a standard creative brief to create a varied and deep set of creative entry points. etc.

We form teams of Medical Writers across varying levels of experience to deliver a range of medical services, including researching, developing, and writing content. You will write medical content for our clients who are developing groundbreaking medicines and treatments. Join us to make a difference in making medicines accessible and affordable. Are you an experienced writer in the medical or pharmaceutical communications industry? Do you get excited working with a respected team that ensures the highest writing quality in the work crafted for top pharma clients? If so, this is where you come in. What Your Day-To-Day Will Look Like: Writing high-quality, medically accurate print or digital documents. Acting as a subject matter authority on the supported therapeutic areas. Procuring, organizing, and handling reference materials from a various sources including peer-reviewed scientific journals, government and medical society publications, and reputable websites. etc.

We are excited to invite motivated Research Scientists to consider a career with us. You will provide evidence based-research to life sciences and healthcare companies to shape strategy and inform key healthcare decisions. Successful candidates will have excellent problem solving and analytical skills; a commitment to teamwork and collaboration; an ability to communicate complex concepts to non-technical audiences; and a willingness to deliver high quality results under tight deadlines. What you can expect day-to-day: Using statistical methods and data visualizations to analyze real-world healthcare data. Creating slide decks, reports, and manuscripts that summarize the results of quantitative analyses. Helping develop simulation models for disease burden, comparative effectiveness, or cost-effectiveness studies. Collaborating across a broad portfolio of sophisticated health economic and health policy research projects. etc.

The Associate Research Economist is responsible for collaborating across a broad portfolio of sophisticated health economic and health policy research projects as a member of a project team. The Associate Research Economist will have a familiarity with the application of research methods (e.g. literature review, modeling, observational research, statistical programming) and the ability to utilize specific discipline knowledge gained through academic and/or work experience (e.g. economics, etc.). This position will perform a wide range of activities including: literature review; analysis; preparing reports, slide decks and meeting notes; quality assurance/review; and other activities, under the direction and supervision of a project leader. etc.

As an Associate Research Scientist, you will responsible for collaborating across a broad portfolio of sophisticated health economic and health policy research projects as a member of a project team. You will have a basic familiarity with the application of research methods (e.g. literature review, modeling, observational research, statistical programming) and will execute a wide range of activities including: project management; literature review; analysis; preparing reports, slide decks and meeting notes; quality assurance/review; and other activities, under the direction and supervision of a project leader. etc.

As an Associate Research Statistician you will develop and implement advanced research across a broad portfolio of evidence synthesis and decision modeling research projects. Associate Research Statisticians collaborate with project teams to execute analytical work, as well as contribute to the development of the department as a whole. Essential duties include but are not limited to: conducting meta-analyses and network meta-analyses, conduct statistical analyses to support projects, draft interim and final project deliverables for clients. etc.

As the primary “storyteller” for your assigned brands, the copywriter partners with senior writers as well as creative leaders to properly understand, articulate and develop copy. Working in a wide variety of mediums, including but not limited to print, collateral, video, digital, etc., you will ensure our content is consistent with the established strategy, brand guidelines, and industry standards. You’ll: participate in the creation of the brand narrative, from the ground-up, present creative to clients and core constituents, engage in productive dialogue as it pertains to brand strategy, narrative arch, and copy to ensure alignment. etc.

You will collaborate across a broad portfolio of sophisticated health economic and health policy research projects. You will perform a wide range of activities including: literature reviews; analysis; preparing reports, slide decks and meeting notes; quality assurance/review; and other activities, under the direction and supervision of a project leader.

As an Associate Research Scientist/Research Scientist, you will responsible for collaborating across a broad portfolio of sophisticated health economic and health policy research projects as a member of a project team. You will have a basic familiarity with the application of research methods (e.g. literature review, modeling, observational research, statistical programming) and will execute a wide range of activities including: project management; literature review; analysis; preparing reports, slide decks and meeting notes; quality assurance/review; and other activities, under the direction and supervision of a project leader.

Day to day tasks as a technologist include: Performing simple and complex processing of blood and body fluids (routine and non-routine procedures). Setting up instrumentation and running calibration samples. Running quality control samples, clinical samples and generating data. Work with QA to perform good documentation and ensure the lab is operating under CLIA, GLP and GCP standards.

The Medical Billing Trainee works within the Billing and Reimbursement department to understand the revenue cycle and provide strategic insight. This person is dedicated to career growth and is looking to learn more about the functions of a business and how each department works together. Responsibilities: receives training and performs duties focused on improving the revenue cycle, learns various staff functions, including operations, management viewpoints, and company policies and practices affecting each phase of business, meets performance goals and objectives set by upper management and determined upon accepting position. etc.

Research associates will be expected to apply focused expertise to projects supporting the development of screening assays, and to the discovery and evaluation of compounds active in the various screens. Candidates should have demonstrated proficiency in molecular biology or biochemistry and be willing to contribute to the company product and intellectual property development as exemplified by scientific articles, patents, and internal publications. Research associates are, in addition, expected to present their data in company settings and, if appropriate, at external meetings and in the literature.

What you'll do... Build automated reports to support internal and external data requests. Build interactive dashboards in Cognos or PowerBI to increase both operational effectiveness and senior management decisions across functions supported by BI: patient care services, provider relations, claims management, network contracting, pharmacy, sales, account management, legal and marketing. You will need to understand the business’ goals, know how to find the data measuring the effort put into meeting those goals, and analyze the information to find trends. etc.

ESSENTIAL DUTIES: 1. Manufacture a variety of Genetic Identity products so as to meet product specifications. Follow production schedules to assure on-time delivery of product. Understand basic laboratory concepts and perform basic lab techniques. 2. Perform assays to assure that products meet existing requirements for purity, activity and functionality. 3. Follow the quality requirements that relate to area. Demonstrates good documentation practices and consistently produces quality products and documentation. Follow existing policies for data recording and record keeping. 4. Understands and complies with ethical, legal and regulatory requirements applicable to our business. etc.

Core Responsibilities: Reviews, processes, and tracks study related documents (e.g. CVs, FDA 1572s, lab certifications, IRB approvals, contracts etc.) obtained directly and/or through vendors. Sets-up and maintains the Trial Master File (TMF). Maintains and disseminates basic study tracking information including, but not limited to: Visit Reports, Regulatory Documents, Site and Team Contact Lists. Prepares, ships and manages inventory of study related supplies. Gathers investigator and site information (addresses, contact numbers, fax numbers, personnel names and email addresses, etc.) Assists in preparing materials for investigator and team meetings, study manuals etc. Core Responsibilities: Reviews, processes, and tracks study related documents (e.g. CVs, FDA 1572s, lab certifications, IRB approvals, contracts etc.) obtained directly and/or through vendors. Sets-up and maintains the Trial Master File (TMF). Maintains and disseminates basic study tracking information including, but not limited to: Visit Reports, Regulatory Documents, Site and Team Contact Lists. Prepares, ships and manages inventory of study related supplies. Gathers investigator and site information (addresses, contact numbers, fax numbers, personnel names and email addresses, etc.) Assists in preparing materials for investigator and team meetings, study manuals etc. Core Responsibilities: Reviews, processes, and tracks study related documents (e.g. CVs, FDA 1572s, lab certifications, IRB approvals, contracts etc.) obtained directly and/or through vendors. Sets-up and maintains the Trial Master File (TMF). Maintains and disseminates basic study tracking information including, but not limited to: Visit Reports, Regulatory Documents, Site and Team Contact Lists. Prepares, ships and manages inventory of study related supplies. Gathers investigator and site information (addresses, contact numbers, fax numbers, personnel names and email addresses, etc.) Assists in preparing materials for investigator and team meetings, study manuals etc.

This position is for the production of a Bio-Techne product line. Duties include; Aseptic technique for the manufacture of sterile buffers. Extraction, centrifugation and dialysis of product from various materials. Sterile fill and finish in a clean room environment. Labeling and Inventory control of products. Daily and weekly maintenance of the clean room environment. Future GMP production and additional duties as assigned. Key Responsibilities: Aseptic technique, Dialysis, Buffer preparation, GMP Production. etc.

B-MoGen Biotechnologies is currently seeking to fill the role of a Research Associate (Cellular Therapies) to expand our genome engineering team. This position would focus on completing customer projects, who are interested in transitioning to clinical therapies and or using cells for research and development. Applicants should have a solid understanding of, molecular and cellular biology and will have an emphasis on human pluripotent stem cells. Key Responsibilities: Participate in unique fee-for-service projects for the development, optimization, and manufacture of genetically modified cell lines, primary cells, mouse embryonic stem cells, and human pluripotent stem cells. Create and run flow cytometry panels. etc.

This position is responsible for preparing conjugated proteins, antibodies, enzymes and microparticles for both manufacturing and research. In addition, this position will be responsible for the preparation and testing of other chemistry related reagents for company personnel. Key Responsibilities: Prepares conjugated proteins, antibodies, enzymes and microparticles for both manufacturing and research according to written and non written procedures. Prepares and tests other chemistry related reagents for company personnel according to written and non written procedures. etc.

This is a great opportunity to get started with a quickly growing biotech company in Minneapolis! The responsibilities of this position are to answer sales and customer inquiries for availability and order status, pricing, and other order-related questions. ESSENTIAL FUNCTIONS: Enter emailed orders into ERP System. Primary point-of-contact to customer questions related to their order. Ensure customer’s needs and expectations regarding their order are met. Follow through with requests to completion or escalate to Customer Care Specialist when appropriate. etc.

We are seeking recent graduates and experienced candidates with strong synthetic backgrounds, excellent scientific and communication skills and who have the ability to assume a wide range of responsibilities including program leadership roles.

We are looking for an Entry-Level Computer System Validation Engineer to support our client in Irvine, CA. This role would work alongside an amazingly talented PSC Team, and works under the leadership of one of the best in the industry! Successful candidates will have excellent verbal and written communication skills, an understanding of the IT realm, and a thirst to learn! Responsibilities: Provide CSV authoring, review and approval of validation documents developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality standards. Initiate/update GxP and Risk Assessments on system. etc.

PSC Biotech Corporation is seeking an Administrative Assistant / Receptionist with exceptional interpersonal skills to support the Pomona office. This is an exciting time for PSC as we continue to rapidly grow our work force. We are seeking an energetic individual to serve as PSC headquarters’ ‘first point of contact’ and a helpful “go-to” resource for our employees and clients. This is a great opportunity if you thrive in a changing and fast-paced environment. If you enjoy helping people with a smile, are great on the phone, and performing administrative functions, this is the position for you. You will be responsible for being the first point of contact for our Corporate Office. etc.

We are seeking a highly motivated engineer to join the Pharmaceutical Development group supporting process development for respiratory drug products. Responsibilities: Support development and optimization of engineered particle inhaled dosage forms. Specific methods may include bench and pilot-scale spray drying. Support development of new technologies. Perform physicochemical property and aerosol performance characterization of solid-based inhalation dosage forms. Support batch manufacture for development, pre-clinical and clinical studies. etc. We are seeking a highly motivated engineer to join the Pharmaceutical Development group supporting process development for respiratory drug products. Responsibilities: Support development and optimization of engineered particle inhaled dosage forms. Specific methods may include bench and pilot-scale spray drying. Support development of new technologies. Perform physicochemical property and aerosol performance characterization of solid-based inhalation dosage forms. Support batch manufacture for development, pre-clinical and clinical studies. etc.

The Pharmaceutical Technician will efficiently, effectively, and safely clean, set-up, and operate machinery in the manufacturing and/or packaging area while adhering to applicable cGMPs, SOPs, FDA, and DEA guidelines. Responsibilities include: Follow Master Batch Records for the manufacturing and packaging of controlled, oral solid dose (OSD) and other dosage forms when required. Prepare raw materials, blends, and bulk accountability throughout manufacturing processes. Performs weight checks for incoming and dispensed materials ensuring compliance with established procedures. Operates scales including set-up, verification, leveling and challenging.

This position will also be responsible for providing escort for equipment qualification with vendors, witnessing controlled substance receiving and dispensing, coordinating laboratory waste disposal and pickup, as well as performing and/or facilitating equipment calibrations. This role may perform other related assignments and duties as required. This position will primarily provide hands on support in manufacturing finished product dosage forms – tablets, capsules, liquids and semi-solids. This position will be responsible for equipment set up, product manufacturing and cleaning as per EHS, DEA and FDA regulations. In addition to assisting the product development scientists in manufacturing finished product prototypes, general support of the laboratory is required. Support activities will include managing inventories for raw materials, personal protection equipment, supplies, etc.

The Shift Process Engineer performs all manufacturing tasks required for the safe production of active pharmaceutical ingredients in compliance with FDA, DEA, OSHA, Federal, State, and Local regulations. The primary objective of this position is to ensure that all manufacturing operations are conducted in a safe manner with a high regard for all applicable cGMP’s and DEA requirements. Working flexibility across a broad range of chemical operations and participation on self-managed work teams is required. Training for and participation on Emergency Response Team is required. Availability for overtime and shift work (including rotating shifts and seven-day operation) is also required.

The Pharmaceutical Technician will efficiently, effectively, and safely clean, set-up, and operate machinery in the manufacturing and/or packaging area while adhering to applicable cGMPs, SOPs, FDA, and DEA guidelines. Primary Responsibilities: Follow Master Batch Records for the manufacturing and packaging of controlled, oral solid dose (OSD) and other dosage forms when required. Prepare raw materials, blends, and bulk accountability throughout manufacturing processes. Performs weight checks for incoming and dispensed materials ensuring compliance with established procedures. Operates scales including set-up, verification, leveling and challenging. Identify, report, and resolve quality issues. Safely and in compliance with batch records and SOPs, set up, operate, and clean manufacturing and/or packaging equipment (oral solid dose manufacturing and packaging may include rotor sieves, granulators, blenders, coaters, encapsulators, compression machines, etc.). etc.

Under general supervision, perform various manufacturing related activities for a GMP compliant Fill/Finish operation applying standard practices, techniques and procedures. Able to assist in the preparation of reports, records, etc., for assigned tasks. PRINCIPAL DUTIES: Familiar with related GMP procedures and requirements, as directly related to the position. Ensure that appropriate procedures and processes are utilized without unauthorized modifications. Ability to set-up, maintain and perform various manufacturing related activities as required for a GMP compliant Fill/Finish operation.

Responsible for the vialing of bulk material, capping, labeling, plate coating and the assembly of kits in compliance with QSR, ISO, OSHA, IVDD, MDD regulations and relevant Standard Operating Procedures. Manual Vialing and coating of components under general supervision as well as using automation (large and small scale) in the production of finished product. Participate in the initiation/change of Quality documentation (i.e. MMRs, SOPs, NRs Variances) as well as ERP (Routers, BOMs, labor and production sheets) related documentation. Employees will be expected to contribute to process improvement initiatives, maintain departmental SOPs and Bluelines and maintain inventory of lab supplies.

Whether their focus is on small molecules, proteins, antibodies, vaccines or oligonucleotides, QPS provides our clients with a full range of services to support the entire spectrum from early discovery, to IND-enabling ADME, to clinical studies. An Associate Scientist in our DMPK department will be a fully-supervised trainee, responsible for formulations, and sample processing and analysis to support preclinical drug discovery and development. Essential Functions: Assist with quantitative and qualitative bio-analytical studies by conducting sample preparation with various analytical chemistry methodologies. Perform routine lab operations, such as sample extraction, preparing reagents, pipette, weigh, monitor, record, label tubes, order and maintain inventory of supplies, and timely disposal of study samples, in a neat/clean manner. etc.

Whether their focus is on small molecules, proteins, antibodies, vaccines or oligonucleotides, QPS provides our clients with a full range of bioanalytical solutions to support the entire spectrum from early discovery, to IND-enabling ADME, to clinical studies. An Associate Scientist in our Bioanalytical department will be a fully-supervised trainee, responsible for sample preparation by various extraction methods; analysis of drug and metabolites in biological samples to support preclinical and clinical drug development programs under GLP regulations; and recording study results and observations. If you have a Bachelor’s degree in Chemistry, Analytical Chemistry, Biochemistry, Pharmacology, or other related disciplines and want to be part of an organization and industry that is making a difference, we would like to hear from you.

The Data Management Associate is an entry level position within the functions of the Data Management Department, including the maintenance of trial related source documents, as well as the timely reporting of clinical data to clients and/or regulatory authorities. The Data Management Associate must possess strong time management skills in order to effectively compile and manage source documents, perform data entry, QC source documents and transcribed data, participate in client interaction and requests, and perform short term or long term projects as required by the department manager and/or department supervisor within contractual timelines. etc.

An Associate Scientist in our DMPK department will be a fully-supervised trainee, responsible for formulations, and sample processing and analysis to support preclinical drug discovery and development. Responsibilities include: Assist with quantitative and qualitative bio-analytical studies by conducting sample preparation with various analytical chemistry methodologies. Perform routine lab operations, such as sample extraction, preparing reagents, pipette, weigh, monitor, record, label tubes, order and maintain inventory of supplies, and timely disposal of study samples, in a neat/clean manner.

The position may reside in any one of the functional areas and carry out the responsibility under some supervision: Operate and troubleshoot the following instruments/equipment to test pharmaceutical samples: HPLC/UPLC, Dissolution apparatus, Karl-Fisher water content titrator, GC, FTIR, UV, Other analytical instruments as directed. Follow analytical test methods, compendial methods, experimental procedures and SOP’s. Document test results in laboratory notebook, in real-time, and communicate status of test results to supervisor. Peer review of laboratory notebooks for technical details. Maintain control of all project related samples submitted to the laboratory. etc.

The QA Coordinator plays an essential role in the management of key GXP (Good Clinical / Manufacturing / Laboratory / Pharmacovigilance / Distribution Practices) Quality Assurance records and documents, including training curriculum management and assignment and Quality Management System records such as deviations, investigations, Audits, Audit Findings, Corrective and Preventative Actions (CAPAs), vendor qualifications and inspections. Responsibilities: Maintains training requirements matrix, tracking role-based training requirements across the company. Assigns training to new and current employees according to the training matrix. Tracks and generates compliance metrics on training completion. etc.

This position will be responsible for providing project management support to all ongoing clinical trials and development programs within Global Clinical Operations. The position will work closely with leadership team in developing, actively managing, and ensuring delivery across all aspects of planning and execution of product development at the clinical stage, as well as supporting other functional areas throughout the product life cycle from pre-clinical to commercial. The successful candidate must thrive in a fast‑paced team environment, and have excellent communication, planning, and organizational skills. We welcome innovative and highly motivated individuals who can bring ideas to life through collaboration, communication, and execution. Key Duties and Responsibilities: Support the team in ensuring that quality clinical trials are conducted per protocol, in a timely fashion, and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and established study budgets. Support the study team with start-up activities, enrollment, site management, data collection, data reviews, site feasibility, database lock, etc. Provide logistical support for Clinical Trial Managers and study team. etc. This position will be responsible for providing project management support to all ongoing clinical trials and development programs within Global Clinical Operations. The position will work closely with leadership team in developing, actively managing, and ensuring delivery across all aspects of planning and execution of product development at the clinical stage, as well as supporting other functional areas throughout the product life cycle from pre-clinical to commercial. The successful candidate must thrive in a fast‑paced team environment, and have excellent communication, planning, and organizational skills. We welcome innovative and highly motivated individuals who can bring ideas to life through collaboration, communication, and execution. Key Duties and Responsibilities: Support the team in ensuring that quality clinical trials are conducted per protocol, in a timely fashion, and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and established study budgets. Support the study team with start-up activities, enrollment, site management, data collection, data reviews, site feasibility, database lock, etc. Provide logistical support for Clinical Trial Managers and study team. etc. This position will be responsible for

This person will be responsible for the general care and upkeep of the laboratory. This includes preparation of reagents/solutions, cleaning of incubators, BSCs and other lab equipment, regular cleaning and disinfection of lab surfaces necessary to maintain the safety of the physical environment and the organization/restocking of lab supplies. Key Duties and Responsibilities: Clean and sterilize laboratory equipment used in tissue culture. Prepare reagents and solutions. Maintain chemical inventory and SDS notebook. Maintain supply levels in laboratory and note items needed.

The Research Associate is an entry-level position that is responsible for the execution and analysis of cell-based, molecular biology, and biochemical assays in support of Reata’s drug discovery and development programs. The ideal candidate will be a dynamic member of the research team who can reliably generate data using validated assays. The Research Associate is expected to work both independently and in collaboration with team members. In addition, the Research Associate must thrive in an environment that demands frequent reprioritization of projects and goals. Key responsibilities include: Execute cell and molecular biology experiments to support drug discovery and development.

We are looking for graduating students to join our RB IS Graduate Development Program. You will be completing IS based project work, collaborating with multiple functions such as Supply Finance, Commercial Finance, and Accounting. Responsibilities: Develop a basic understanding of each function, specifically around the organizational structure, operational processes, common issues and pain points. Perform system analysis, design, programming, testing, and documentation. Monitor and analyze existing application systems. Recommend enhancements on technical function and business utility. Constantly improve IS systems through current/best in class IS practices. etc.

We are looking for an MBA student to join our brand management team as an Assistant Brand Manager. This position is responsible for the development of assigned brands through the achievement of specific growth objectives. The position resides within the US Marketing function and will assume support for the Brand Manager for assigned brands within the category in Equity, Activation or Innovation capacities. The Assistant Brand Manager will play a key role in supporting the development of the overall category strategy, and is expected to drive the growth of his/her assigned brands through excellent marketing execution. Responsibilities: Support in developing and delivering the vision, US in-market activation excellence and gross profit for the brand. Champion pipeline and secure incremental funding for launches. Manage the day-to-day interface and key business activities of the portfolio. etc.

The R&D Technician will apply technical knowledge working toward multiple project goals and objectives within established timelines. Perform laboratory tasks using general microbiological laboratory techniques. Perform appropriate practices and procedures in line with standard operating procedures. Maintain laboratory records in compliance with Good Laboratory Practice standards. Prepare microbiological media, reagents, glassware, and process contaminated materials. Read and interpret microbiological test results. Maintain an adequate inventory of laboratory supplies. etc.

The Manufacturing Associate I is responsible for the processing of commercial products at the Gainesville Site. This includes receiving order instructions (Batch Records), weighing and staging of materials, solution preparation, solution application (coating beads), drying, screening, machine set-up, sampling, packaging, and storing of the products.

This position has responsibility and authority for delivering top quality firmware solution required to meet overall radiotherapy product requirements.  This includes: Prototype, design, implement, test, debug and maintain firmware (device drivers, BSPs and Hardware Abstraction Layer library) that serve as the bridge between hardware resources and application software. Participate in completing test cases, conduct embedded systems verification and generating test reports to support a 510(k) submission and FDA clearance. Participate in cross-functional project teams with scientists, technical support and other engineers to resolve software issues.

We are looking for a Temp Animal Care Technician. This person provides routine husbandry care and maintenance of animals, including but not limited to feeding, watering, cage changing, and health checking of animals in the vivarium as well as maintenance of the facility. The person in this role also applies technical knowledge to perform the routine care and maintenance of research animals. Responsibilities: Performs basic care of research animals for experimental purposes: daily observations to check animal health status and environment; reports changes in environment and/or animals; changes and cleans cages, equipment, water bottles and food. Unpacking and housing animals upon arrival. etc.

Supports non-drug project teams responsible for process design and improvement projects and change management within Global Development. Provides administrative and project support to EPIC & PMO team and EPIC & PMO project teams, others leaders/teams as assigned. Includes managing meeting invites and logistics, coordinating events, meetings and projects with administrative support for applications: Microsoft, SharePoint, Concur, as required, or other specialized support as required. Job Duties: Manage EPIC/PMO project workshops, events and meetings. Order and prepare session materials and AV equipement/support for EPIC events. Book rooms and order food from internal and external catering for events and meetings. etc.Supports non-drug project teams responsible for process design and improvement projects and change management within Global Development. Provides administrative and project support to EPIC & PMO team and EPIC & PMO project teams, others leaders/teams as assigned. Includes managing meeting invites and logistics, coordinating events, meetings and projects with administrative support for applications: Microsoft, SharePoint, Concur, as required, or other specialized support as required. Job Duties: Manage EPIC/PMO project workshops, events and meetings. Order and prepare session materials and AV equipement/support for EPIC events. Book rooms and order food from internal and external catering for events and meetings. etc.

We are seeking a motivated R&D associate to join the VI-Next group to support our effort in developing new in vivo disease models and testing the therapeutic potential of new candidate molecules. The new recruit will contribute to project advancement by performing in vivo work and in vitro assays such as cell culture, immunoassay and flow cytometry. The ideal candidate must have the ability to perform both in vivo and in vitro laboratory work. Strong skills in cellular and molecular biology, and knowledge of immunology are highly desirable. Involves: Immunization and injection of mice, disease and body scoring, collection and processing of blood and tissue samples. Ex vivo analysis of mouse and human samples using isolation of specific cell population techniques, primary cell culture, immunoassays such as ELISAs, ELISPOT or MSD and flow cytometry. etc.

Reporting directly to the Senior Director of Regulatory Affairs, the Associate of Regulatory Affairs, CMC is responsible for providing support for regulatory activities related to chemistry, manufacturing, and controls for each product development area from early development through BLA. The incumbent will also provide the organization with regulatory and scientific expertise to enable high quality and effective health authority and team communications to effectively support the product development process. PRIMARY RESPONSIBILITIES: Prepare CMC-related submissions and manage regulatory writing and timely delivery of high quality technical documents including, briefing books, quality modules for clinical trial and marketing applications, drug master files, and responses to regulatory authority inquiries. Interacts with colleagues in other departments, other R&D functions and RA functions to deliver high quality dossiers, documents and materials in accordance with corporate and team goals.

North suburban Chicago contract pharmaceutical manufacturing company needs a Production Chemist to operate and clean equipment used in the production of bulk chemicals. Responsibilities include: Operation of all plant equipment. Cleaning of all plant equipment. Interaction with clients and sales team. Directing operators and technician

REMD Biotherapeutics is seeking exceptionally motivated scientists with strong background and proven track records in molecular and cellular biology to join our Drug Discovery team located in Camarillo, CA. Responsibilities in this role include: Design and perform cutting-edge research that utilizes genetic engineering to create novel therapeutic proteins and the cell-based assays needed to assess their biological activity. Work independently and collaboratively to develop and execute novel physical and biological assays required to evaluate new antibody-derived therapeutic proteins. Organize, analyze and present complex data generated on novel proteins in a scientifically rigorous manner for the purpose of advancing clinical candidates.

As an expert in single use tangential flow filtration, Repligen offers TangenX® Flat Sheet TFF Cassettes with unparalleled flexibility and scalability from process development to production scale. Since 2008, SIUS tangential flow filtration products have been universally accepted as the first purpose built single use tangential flow filtration cassette ideally suited for downstream purification operations. The individual will work in the manufacturing of novel high performance ultrafiltration and microfiltration membranes – with an ultimate goal of impacting bioprocessing biological molecules. The work will also include improvements in membrane formation processes. The work will require a good understanding of polymers and membrane formation processes. We are seeking a Membrane Engineer within the operations group to focus on the manufacturing of existing and new ultrafiltration membranes. etc.

This assembly position performs a wide variety of fiber assembly, filtration product assembly or sub-assemblies. Determines and/or follows methods and sequence of operations in performing fiber bundling, filter potting, filter welding, fitting on assembly units and packaging. The employee also works as a team member in whatever capacity and job function is required to deliver a quality product to our customer in a timely fashion. Performs manual assembly of complex fiber, membrane, and polycarbonate components, etc.

Let’s talk about the team and you: Operates and monitors equipment/process relevant to LSR moulding by following the methods and sequence of operations as defined by verbal instructions, Visual Aids, Quality Forms and/or Routers. Let’s talk about Responsibilities: Performs to individual goals established during MyDay meetings. Operate and monitor production equipment/process – relevant to LSR. Assures product meets or exceeds company and customer expectations of quality and workmanship. Accurately reports production data. Other tasks and responsibilities as assigned. Let’s talk about the team and you: Operates and monitors equipment/process relevant to LSR moulding by following the methods and sequence of operations as defined by verbal instructions, Visual Aids, Quality Forms and/or Routers. Let’s talk about Responsibilities: Performs to individual goals established during MyDay meetings. Operate and monitor production equipment/process – relevant to LSR. Assures product meets or exceeds company and customer expectations of quality and workmanship. Accurately reports production data. Other tasks and responsibilities as assigned.

In this role, you have the opportunity to directly impact Philips’ success by qualifying leads and uncovering opportunities adding to the sales pipeline. The Campaign Management Specialist is responsible for proactive inbound and outbound prospecting and lead management; coordinating campaign strategies focusing on development, implementation and findings. This role will act as a layer between marketing and sales for all product lines including Patient Monitoring, Ultrasound and Imaging Systems. Responsible for building relationships through marketing activity – outbound call campaign, inbound inquiries, trade shows and referrals. The goal of a Campaign Management Specialist is to take a perspective lead from a campaign, generate interest to customer, qualify the lead using the budget, authority, need, & timeframe to approach and communicate the opportunity with the appropriate Account Executive for follow up. Additionally, maintaining and updating customer information in SalesForce.com and fulfilling customer request for product information. etc.

The company is seeking an entry-level marketing person available immediately. We are seeking a fast-pace individual with experience in internet-driven social network marketing strategies with focus on use of Linkedin and Twitter to generate leads. Candidates must be located in San Diego, CA. Experience in internet-based and email-based marketing strategies is needed. Experience with website design, WordPress, email marketing and design, and SEO strategies are a plus. Ideal candidate should have some scientific background to be able to understand and implement novel strategies, evaluate competition, customer’s needs, and the services provided by the Company. Compensation will be based on commissions generated from new revenue. etc.

Conduct routine and non-routine analysis of in-process and finished products. Perform biochemical and/or chemical analyses of product to ensure stability. Compile data for documentation of test procedures that may include biochemical and chemical assays, initial lot release and stability testing and formulation studies. Revise and update standard operating procedures as needed. May participate in special projects as method validation or method transfer on analytical department.

The Systems Integration Engineer is responsible for integrating new biology and engineering developments into the product line and transferring to manufacturing. In this role he/she will work closely with the engineering and biology teams to develop and perform optimization and characterization experiments. He/she will also provide external customer support for system installations, maintenance and repair.

Experienced and motivated lab manager and research technician to assist with daily operations of a dynamic gene therapy research lab and support development activities. The position involves managing day-to-day lab activities, including but not limited to purchase and organization of reagents and supplies, maintenance of lab equipment, and simple experimental and administrative support to a dedicated team of scientists. Responsibilities: Organize and maintain structure of the lab, managing day-to-day activities and coordinating meetings with external partners. Be responsible for shipping and receiving of materials. Participate and coordinate daily lab tasks, including maintenance of mammalian cell culture lines, and other simple lab experiments to support scientists. etc.

The two-year tech rotational program at Roivant begins summer 2019 and will give you experience across a variety of functions within Roivant and our subsidiary companies. Throughout our businesses, analysts will look for ways to integrate modern technology and will have the opportunity to develop Roivant’s innovative health and pharmaceutical companies in their early stages. As an analyst, you will have the opportunity to rotate through the following teams: Digital innovation, Digital Product, Devops, Data Architecture

POSITION SUMMARY: Conducts required biochemical or other laboratory experiments while keeping orderliness and cleanliness in the laboratory. Supports the scientific, engineering, marketing, and project management personnel in all facets of activities associated with the procurement, fabrication, processing, experimentation, and evaluation of medical products and processes. Maintaining lab equipment, maintenance, calibrations, etc. as required to sustain lab work flow/readiness. Monitors and stocks an appropriate inventory of tissue and lab supplies. Executes assigned protocols and work instructions and completes proper documentation. etc.

This is a full time position with career advancement opportunities within the company. Responsibilities include: Ability to perform standard analytical and preparative procedures required for the development and analysis of monoclonal antibodies. Ability to characterize antibodies by designing and optimizing experiments, interpreting data, and selecting the best possible products to develop. Capacity to utilize established, routine procedures and follows instructions from supervisor. Strong scientific background and business communication skills.

The Associate I, Nucleoside Manufacturing will focus on support of our Contract Nucleoside Manufacturing sites including oversight of both routine manufacturing and tech transfer of new/improved processes to the sites. Nucleoside manufacturing ensures uninterrupted supply of API and sterile drug product in support of Sarepta’s manufacturing organization. The position is responsible for manufacturing trending, interaction with Sarepta process development, and production planning and execution with contract manufacturing organizations (CMOs).

The Laboratory Operations Assistant will support laboratory scientists in the pursuit of new therapeutics with the potential to change patients’ lives. The candidate will be an essential part of maintaining a highly functional research lab in the biotech industry. Responsibilities include: Assist scientists and facilities team in conducting laboratory support tasks as needed. Stock and control inventory for the research lab. Perform routine maintenance lab maintenance including daily, weekly, monthly and as needed equipment maintenance .

The Analytical Sciences Group at Seattle Genetics is seeking a highly motivated Research Associate with experience in release and characterization method development for monoclonal antibodies and antibody drug conjugates. His/her responsibilities will include development and qualification of chromatographic and electrophoretic methods to support process development, quality control and physicochemical characterization of therapeutic antibodies and antibody drug conjugates. The candidate will (1) Conduct experiments to support method development and qualifications for mAbs and ADCs (2) Generate and interpret high quality data and technical reports to support various regulatory submissions including IND, BLA, IMPD, etc., and

The Analytical Sciences Group at Seattle Genetics is seeking a highly motivated Research Associate to join the mass spectrometry (MS) core group. The ideal candidate will possess hands-on experience with protein mass spectrometry methods and data analysis. Primary responsibilities will include generation and interpretation of MS-based characterization data for monoclonal antibodies (mAbs) and Antibody drug conjugates (ADCs) in support of clinical and commercial programs. Responsibilities include: Conduct experiments aimed at characterizing posttranslationally modified mAbs and ADCs. Generate and interpret high quality data and technical reports to support various regulatory submissions including IND, BLA, IMPD, etc..

Laboratory Bench Position that performs routine release testing for raw materials, intermediates, and final products within a cGMP environment. Principle duties include: Perform testing of raw materials and products. Perform instrument qualification and maintenance. Perform test method validation/verification. Review analytical data for completeness, accuracy, and compliance

The position will hold responsibility for assisting in the manufacturing of Sedia’s immunoassay product lines encompassing lateral flow and ELISA test. The holder of this position is expected to follow the guidance of their direct supervisor to assist in delivering company products in a timely and cost effective manner. The position will contribute in building product subassemblies or final assemblies. The Manufacturing Technician will adhere to all applicable regulations, policies, and procedures for health, safety, and environmental compliance.

This position would be a full-time exempt position (40 hours per week) at our primary laboratory facility in Northeast Portland. The successful candidate will be responsible for running laboratory tests, recording data, performing some degree of data analysis, drafting protocols, and communicating with managers from R&D and other departments. They will also be asked to participate in production of prototype products, and assist in transition of those procedures (through training and/or record-keeping) to our manufacturing department. Workflow is approximately 50-70% laboratory work, with the remainder being office work. The nature of our work requires the candidate to be capable of working comfortably in a BSL 2 laboratory

Support includes independently performing routine and non-routine applications of cellular/molecular genetic technology to quantitate and manipulate genetic material. Perform general molecular techniques such as plasmid purification, gel-electrophoresis, RNA transcription, and bacterial culturing. Perform nucleic acid analysis (RNA/DNA integrity analysis, real time qPCR, digital PCR) and analyze results. Work with supervisor to plan and execute new projects as assigned according to the timelines and ensure documentation meets GLP/GMP requirements.

Role is a Test Engineer, an individual contributor responsible for development and design of test fixtures, software and verification and feasibility testing as it relates to R&D development activities for capital devices. Follow FDA guidelines for Design Controls and internal quality processes. Interact with suppliers to ensure proper process controls on the parts we design into our products. Work cross functionally with marketing, quality, manufacturing and sustainability to ensure the customer experience is the best we can make it.

This position will provide engineering support in the upstream process for tech transfers to contract manufacturing organizations as well as technical support for ongoing manufacturing operations through process monitoring, troubleshooting, and process improvements. Key duties include: Support scale-up, process optimization, technology transfer, and start-up activities. Includes onsite presence at our contract manufacturing organizations. Support the development of new processes and technologies to improve yields, product quality, and process robustness.

The individual must have good understanding of primary cell immunology and tumor biology. Previous experience in related areas is preferred but not required. Responsibilities include: Planning and executing human T cell studies focused on optimizing processes for manufacturing CAR-T cells at pilot and GMP scale. Coordinating experiments and projects collaboratively with R&D team and manufacture team. Maintain detailed documentation records and author reports, SOPs, batch records and other materials to facilitate tech transfer, manufacturing and regulatory submissions

The Firmware Verification Engineer of Sotera Wireless will develop, implement, perform, and document both automated and manual software verification tests for the company’s proprietary embedded software. The verification engineer will be required to collaborate with all product development teams: embedded software, systems software, hardware, data science, and software quality assurance.

Under the direct supervision of the Operations Manager, the Patient Access Specialist is responsible for facilitating patient access services by managing incoming calls, assisting clinic customers at first point of contact, and streamlining clinic-wide communications. Also responsible for the daily work schedule for a group of physicians/staff by answering the phones, obtaining records, verifying patient information, scheduling appointments, entering charges and collecting payments.

We are looking for a Research Audiologist that will be responsible for research, subject and data management related to activities pertaining to Alpha and Beta product evaluations, pilot testing, and hearing aid fitting methods. This position will assist in determining the direction of product development. Work will be collaborative with other researchers and personnel in Minnesota.