Links to 1240 Entry-Level Biotechnology & Life Science Jobs

The candidate must be able to learn complex procedures, efficiently execute microfluidic characterization experiments, perform data analysis, and communicate results and observations effectively. Key responsibilities include: Perform experiments and analyze data to help us develop robust microfluidic consumables. Use your understanding of microscale transport phenomena and troubleshooting skills to engineer new products. Communicate results clearly and contribute data for making critical design decisions

Responsibilities include: Build applications, libraries, and services to make machine learning more available within the company. Expand the variety and complexity of machine learning modes we can use. Develop checks and tests to ensure we're delivering reliable, quality results. Optimize machine learning, computational, and data processing pipelines.

he person hired for the position of Cloud Analyst will work with the global process teams to build and deploy standardized global cloud solutions as part of the Polaris project. Responsibilities include: Design, develop and test data pipelines established to deliver data into data storage based on a function design specification. Analyze, design, code/develop and implement changes to resolve break/fix issues to resolve and close tickets during both testing cycle of project and in production. Understand the functionality of relevant process area and data that will be required to Build, Test and implementation.

Under close supervision, this position is responsible for a variety of manufacturing support functions involving the operation of lab equipment and conduct of procedures/tasks according to established GMP, under the direction of senior staff. Responsibilities include: Carry out production tasks in support of manufacturing goals and objectives. Operate laboratory equipment safely, as trained and directed, in accordance with established practices. Maintain records and notebooks as directed in a neat, thorough and accurate manner. Perform required data entry on company planning and materials management system. Report results to supervisor. Perform complex formulations, component and material evaluations, equipment calibrations and maintenance

The position of Production Specialist I is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will perform work required for the assembly of components, devices, and/or the final product depending on the trade assigned. Duties include: Performs work required for the assembly of components, devices and/or the final product with supervision. Ensures quality of product using standard operating procedures, templates, training and supervision, and good judgment.

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.

This position is responsible for supporting and improving quality engineering methodologies and providing quality engineering support within manufacturing, or system/services support. Responsibilities include: Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements. Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements. Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues. Design and conduct experiments for process optimization and/or improvement. etc.

The candidate for this Associate Scientist I/II position will be working in the Biotransformation group of AbbVie’s Bioanalysis and Biotransformation department. This position will be focused on preparing biological samples and performing LCMS assays to characterize biotransformation of large molecules, including antibodies, antibody-drug conjugates, and proteins. The individual will be expected to have solid experience working with analytical instruments, especially HPLC and MS, and preferred to have experience working with protein samples and protein chemistry techniques.

The candidate will be part of the New Modality Analytics Group within Protein Analytics that is mainly focused on method development and implementation of various HPLC, UPLC, and CE based analytical methods of AbbVie’s Biologics. The successful candidate will contribute to the development and testing of analytical assays and will contribute to the continuous improvement and innovation within the group and the PA department.

This position will contribute to the development and validation of qualified reagents and generate data to support IVD products. Protocols and associated data may include immunohistochemistry (IHC), western blots, ELISA or other immunoassays, immunofluorescence or others as required. In addition, this position will be expected to complete scientific and technical tasks on aggressive timelines and to work as part of a team on varied tasks with changing priorities.

This position will provide extensive technical support for fulfilling contract requirements for immunological assays. Duties include: Assist in the development and qualification of new immunological assays including; but not limited to, the following:Multicolor-Flow Cytometry based assays, cytokines and other soluble biomarkers Multiplexing assays (Luminex, Aushon, MSD platforms), ELISA, ELISpot, and Neutralization Assays, among others. Responsible for organizing and ensuring efficient daily operation of the laboratory including: stocking laboratory with necessary reagents and other materials used for experiments and inventory of reagents and samples. This position will ensure the accuracy of record keeping of experimental conditions and results. Assist withdaily scientific duties in the laboratory in order to meet commercial and government contract obligations in a timely manner. Lab activities mayinvolve interaction with other functions and departments.

The Research Associate I, under direction of the Molecular Sciences team, will support innovative experimental research that advances AbSci’s proprietary E. coli expression platform.   Primary responsibilities include providing core support to ongoing DNA construction, strain engineering, and small-scale protein expression activities.  Daily activities will include management of the Molecular Sciences laboratory consumables and sample libraries, preparation of common research reagents, and providing assistance to ongoing experiments.  The ideal candidate will demonstrate rapid mastery of assigned tasks and the capacity to take on additional technical responsibilities within an expanding team. 

The Materials Associate I is primarily responsible for completing general warehouse functions. This includes, but is not limited to labeling and boxing product, verifying incoming product counts, conducting inventory counts, and reviewing documentation in order to maintain up-to-date inventory records. The Materials Associate I is also responsible for the packaging and shipping of finished devices to customers and sales representatives.

The Engineer 1 - Field Service is the responsible for providing highly visible onsite and remote technical support to customers of Acutus Medical. This includes but is not limited to installation, general servicing, repairing, problem solving and supporting customers and medical centers using the Acutus’ electromedical equipment. This Engineer works closely with Acutus’ internal teams to ensure customer feedback, experiences and input is communicated to the appropriate internal team members.

The Quality Systems Associate is responsible for supporting day-to-day operation and may have individual responsibility for working with new, or transferred, products to provide quality oversight to ensure regulatory compliance. The position is accountable for the applications of industry standard quality practices and tools as applied by Adaptive Biotechnologies. The position requires the ability to manage priorities from multiple projects and tasks utilizing effective written and oral communication skills. This position will apply quality systems knowledge, problem solving, and judgment skills to ensure the appropriate balance of quality, compliance, and business needs.

We are seeking a skilled molecular or protein biologist to join our Antibody Discovery team. The Research Associate will work in a small team setting to support Adimab’s novel antibody discovery, maturation, and production platform. This role will closely interface with the Protein Analytics, High Throughput Expression, Molecular Sciences, and Computational Biology teams. Duties include: yeast propagation, mammalian cell culture, antibody library construction/selection, etc.

The Manufacturing Associate performs GMP manufacturing operations safely, reliably and in compliance with stated processes. Principle responsibilities include: 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.

The QA Auditor I performs quality assurance duties at the assigned facility to prevent or eliminate defects in products for sterile filling operation or in final inspection and packaging operations. This individual must work in a detail-oriented, compliant manner in a high stress environment where adherence to deadlines is critical. The individual must display exemplary level of integrity at all times. The QA Auditor reports directly to the QA Supervisor or Manager of Quality Operations. Duties include: Check the production lines to make sure the right product is issued to match batch record. Monitor the production processes and ensure consistency of procedures. • Review/approve raw materials or components for use in production, etc.

Hours are from 3PM-11:30PM. Under limited supervision and guidance of the Microbiology management team, the Microbiologist I is responsible for the following duties: Performs routine microbiological testing of products, raw materials, components and controlled environments according to site Standard Operating Procedures and compendial methods. Documents routine procedures following laboratory and company guidelines. Issues and revises GMP documents such as SOP’s, protocols/reports, testing monographs, data sheets, etc.

We are seeking a Senior Research Associate to join our Immunology group. This person will be responsible for developing, qualifying, and performing assays to assess immune function in support of Immuno-Oncology programs. Responsibilities include: Support the characterization of the immune state of ex vivo and in vivo tumor models through a variety of means including FACS analysis. Develop assays to assess immune function including T-cell, NK cell, macrophage function in a variety of formats. Integrate technologies that improve or expand the ability to assay molecules by working with teammates, collaborators, vendors, and staying abreast of the literature

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 supplier quality management, the Supplier Quality Engineer I will support all aspects of the Supplier Quality processes which include but not limited to the items listed below. Complies with FDA, ISO, AATB, and all other applicable international and state regulatory requirements, best industry practices and internal processes. Identify and bring issues to management when a compliance gap is identified.

The inventory expeditor will work with other members of the inventory team to increase company profitability and customer satisfaction by delivering complete, accurate and on-time deliveries to the company’s customers. Responsibilities include: Deliver orders/inventory via the most effective route to ensure devices/products are delivered according to established time frames. Maintain communication with the Inventory Manager during deliveries to ensure any updated instructions are received. Operates a motor vehicle according to applicable state laws as needed.

Research Associate I is responsible for assisting senior R&D staffs to design, develop, and validate clinical diagnostic assays spanning a wide range of Next-Generation sequencing and microarray technologies. Duties include: Aid in the design and development of clinical diagnostic assays for use in a CLIA/CAP regulated setting. Participate in drafting Standard Operating Procedures for new assays. Perform research experiments, such as primer design and preparation, PCR, electrophoresis, gel imaging and analysis, Sanger Sequencing, Next-Gen sequencing library preparation, aCGH microarray labeling, and sequencing analysis.

As a Lab Assistant under our Quality Control (QC) team, you will be overseeing Clinical Lab Quality Control, including equipment maintenance and reagent QC support. Responsibilities include: Oversee equipment preventative maintenance/routine maintenance and systems, as well as driving routine multi-system testing. Manage general temperature & humidity monitoring. Supervising general reagent quality control and systems. Regularly communicate with vendors/suppliers and coordinate on-site maintenance or repairs. Maintain current knowledge of reagent stability and storage, proper handling of reagents, and associated safety protocols. Maintain laboratory safety by ensuring work area is safe and clean, noting any problems that may require prompt and proper repair.

The clinical assistant I will provide support and help organize work flow for the genetic counselors, laboratory directors, and medical directors in the clinical diagnostics department. He or she will also share some general responsibilities of the Client Services department, such as providing testing information to clients about our products and services, patient test status, and routing calls throughout the organization as needed. Providing detailed information (technical and clinical) about genetic tests offered by Ambry Genetics, communication of relevant results, and basic results interpretation, if necessary. Work collaboratively with the Clinical Diagnostics team, laboratory personnel, accessioning department and sales & marketing department to make sure the needs of our clients are met.

Monitor compliance to in-house standard operating procedures (SOP's) and Current Good Manufacturing Practices (CGMP's), pertaining to the manufacturing, packaging, storage, and distribution of finished product. Inspect and test components, labeling, sub-assemblies and finished product for conformance to all written specifications. Ensure complete, accurate, and proper performance of all QA functions, including documentation. Monitor all processing steps to ensure conformance to Manufacturing specifications (work order) and processing methods. Assist in verifying the complete, accurate and proper performance of all Quality Assurance functions, including documentation to ensure compliance with CGMP's, and ISO 9001, MDD, EN46001, production and corporate standards.

The Process Automation Engineer – Packaging I is the SME of Visual Inspection, Automatic Packaging, and serialization, working as part of the Inspection/Packaging Team for the New Albany facility. The Process Automation Engineer – Packaging I provides technical support and project leadership to all Visual Inspection related subjects for New Albany site. This position will support both commercial and Research & Development operations. The Engineer must possess the ability to manage multiple tasks simultaneously, identify and implement continuous improvement opportunities, and drive procurement and project closure in an FDA regulated environment.

The Validation Technician is responsible for validation equipment preparation, protocol execution and final report generation as directed. This position will be primarily responsible for the execution of protocols associated with the installation, operation qualification and requalification of equipment, and utilities used in the analysis and manufacture of sterile pharmaceutical drug products.

This entry-level position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensure aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective and professional behavior is displayed at all times. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company goals. The Team Member will be able to participate in all aspects of the Equipment Process.

This Cell Culture Manufacturing Associate position will support the on going commercial operations for drug substance intermediate and the start-up of new clinical and commercial drug substance manufacturing operation in Thousand Oaks, CA. The Associate will execute production operations on the manufacturing floor including execution and coordination of commissioning and qualification of process equipment. This role will interface between the GMP manufacturing teams in the plant and our partner organizations.

The Associate Scientist’s responsibilities include, but are not limited to, the following: Design and execute experiments for analytical support of biotherapeutic proteins using HPLC, LCMS, and capillary electrophoresis. Develop and optimize analytical methods. Troubleshoot and maintain analytical equipment in good working order. Analyze and clearly document experiments in Electronic Lab Notebook (ELN).

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.

The Research Scientist is an integral part of the AMRI team, contributing to our success by the cultivation of microorganisms; the screening of biocatalysts and process conditions; and the production, isolation, purification, and analysis of the products of fermentation and/or biochemical transformation.

The Quality Assurance Associate is an integral part of the AMRI team, contributing to our success by assuring that all documentation, procedures and protocols comply with GMP and FDA guidelines. In this role you will: Conduct batch record and test data reviews, and approve batches for release. Assist in maintaining compliance of Environmental Monitoring, Equipment Calibration, and the Equipment Maintenance Program. Issue Deviation, CAPA, and OOS investigations. Track investigations and outcome. Review and recommend approval of indicated actions to senior associates or quality management.

The Quality Control Microbiologist performs quality activities in support of product production and releases. The QC Microbiologist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending and reporting results. This includes: Perform microbiological testing (endotoxin, bioburden) for water. Perform microbiological testing (endotoxin, sterility and bioburden) for raw materials, in-process materials, intermediates and final product. Read, trend and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results. Maintain historical files on organisms found in classified areas; microbial identification and trending. etc.

Analytical Lab Group's West Coast location is looking for laboratory technicians to perform environmental monitoring at client facilities and microbiology testing in the microbiology lab. This is a full-time position. The schedule will be Monday-Friday, 7 a.m. to 3:30 p.m., but you must be able to work flexible hours, including different shifts and weekends. At this time, the starting hour is 5 a.m. and will require OT.

This position is responsible for daily data entry as it relates to Contract Support related activities. This includes order processing, shipping paperwork, invoicing, advanced ship notices, product returns and other duties as assigned. Position Responsibilities: This includes: 1. Order Entry – Receipt/entry (EDI, Fax, e-mail). 2. Shipping/Invoicing – Prepare all docs pre and post shipment, maintain files, send invoices and advanced ship 3. CSII Orders – Process, verify, track orders, and maintain electronic 222 log. 4. Receive and update returns log for all return requests received by customers. 5. Evaluate each return to determine the appropriate return policy. 6. Create Disposition Authorization. 7. Coordinate with return company and/or customer on return or destruction authorization. 8. Create credit request for approval once material returned or destruction notice received. 9. Enter approved credits/debits into customer accounts. 10. Provide customer with credit and any supporting documentation. 11. Performs other duties as assigned or requested.

This list is not comprehensive but meant to represent the most common or important duties of the position. Develop, document and implement standard molding processes and methodologies. Use scientific molding method to validate new molding processes and re-validate existing/legacy molds. Research, design and develop manufacturing processes and new technologies. Participate in Tool Design Reviews and recommend improvements to optimize molding, setup, and overall manufacturing. Work with design, manufacturing, production, engineers and tooling during the entire development cycle. Emphasis on new mold sampling prior to transfer to production. Research, develop and implement manufacturing process controls, machinery modifications and improvements.

This is a hands-on lab-based role in Induced Pluripotent Stem Cells (iPSCs) group with a focus on iPSC genome engineering and differentiation using ASC’s gene editing technologies. Responsibilities include: Work closely with a multi-function team to deliver engineered iPSCs cell lines and a variety of other cell types. Work on gene editing projects in iPSCs/stem cells, preparing reagents, performing cell culture and cell-based assays. Work on iPSCs generation, differentiation and characterization. Apply scientific knowledge, critical thinking, and problem-solving abilities to troubleshoot and refine methods and assays. Interpret genotyping data from Sanger sequencing and Nextgen sequencing

The primary mission of our Technicians is to operate injection molding equipment to successfully meet production demands and quality standards. Duties include but are not limited to: Utilize your mechanical skills to install, remove and adjust Injection Molding machinery and equipment. Troubleshoot Injection Molding machines, follow process to resolve failures, other problems. Coordinates and sets up machines, robots and other equipment performing necessary tests to ensure company compliance. Trains employees in the correct procedures for operation as needed. Assist in preventative maintenance and repair of molding machines, molds and peripherals (robots).

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.

The technician is responsible for the operation of equipment according to established Standard Operating Procedures and Master Production Records for the manufacture of therapeutic proteins and vaccines in accordance with Current Good Manufacturing Practices (cGMP’s). Operates production equipment such as bioreactors, centrifuges, filtration devices, chromatography equipment, washers, autoclaves, tanks. Weighs and checks raw materials, assembles and cleans process equipment, monitors processes. Performs SIP, CIP and manual cleaning and sanitization of equipment. etc.

In this position, the successful candidate will apply their skills and expertise in protein biochemistry to identify targets bound by patient derived antibodies using protein biochemistry and molecular biology techniques. These include protein and carbohydrate arrays, immunoprecipitation, and other protein biochemistry techniques. Responsibilities include: Perform immunoprecipitation and array screening of antibodies selected for testing in in-vivo tumor models. Generate lysates and subcellular fractions from tissue culture cells (including radiolabeled cells) and mouse tumors. Perform pilot immunoprecipitation screens on lysates from tumors and radiolabeled cells.

The Associate Process Engineer is responsible for on-going production, validations, and continuous improvement of new and existing manufacturing processes. He/she contributes in a creative and collaborative ways to achieve the company’s goals of producing market leading products through positive patient outcomes. Responsibilities include: Team member of projects involving design, manufacturing, and quality resources, both internal and external. Knowledge of general manufacturing technologies (plastic injection molding, stamping, milling, turning, assembly methods, various fastening techniques) including low to medium volume 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

The Associate, Regulatory Affairs assists the regulatory representative to Project Teams for assigned projects or products and by providing regulatory tactical support and strategy under guidance from manager. Ensures that clinical trials meet regulatory requirements as designed. Prepares and ensures rapid and timely submission of new drugs and maintain applications to sustain approved status of marketed drug in conjunction with more senior members of the department.

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.

Setup, maintain and operate production line equipment to produce intraocular lenses according to production specifications and standards. Perform inspections to verify accuracy of machining against specifications to maintain quality and performance standards using set up equipment. Conduct initial troubleshooting for defect causes and machine problems . Make minor mechanical repairs as required to maintain production specifications and standards. Report unusual conditions and problems to supervisor and practice good housekeeping. Support, encourage and participate in team related activities; report ideas or suggestions to supervisor.

Duties and responsibilities include: Conduct critical chemical and physical analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Baxter manufacturing facilities. Work under minimum supervision. Use sophisticated laboratory instrumentation and computer systems to collect and record data. Perform advanced assays requiring precise analytical skills and understanding of biology and chemistry principles. Complete all testing, including special project / protocol testing in a timely and appropriate manner. Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.

This position is a key role in Maintenance in our Manufacturing Operations. Primary focus will be on implementing continuous improvement, new business, and capacity expansion projects. Additional focus will also be on manufacturing equipment reliability and process support working within the Operations Group and Engineering. Cross-functional project management will be involved in this role as well. Duties include: Design/modify precision assembly and/or manufacturing equipment. Manage multiple projects with minimal supervision. Prepare estimates for various tasks and projects. Manage capital projects both directly and through coordinating engineers.

Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of Baxter’s products. Responsibilities include: Track of status and progress of regulatory documentation. Review, edit and proofread regulatory documentation. Assist in preparation and review of labeling, SOP’s, and other departmental documents. Compile under supervision regulatory documents for submission

The primary responsibilities of this role, Data Engineering Graduate Scholar, are to: Design and develop pipelines to connect external data sources to a data lake in a collaborative effort with Bayer R&D IT and Bayer Biologics; Design and develop workflows to link datasets in the data lake based on shared ontologies; Design and develop REST APIs and web-based UIs to provide access to linked datasets in the data store; Gain expertise in frameworks for schema discovery from schema free sources and use expertise gained to extract knowledge from existing schema-free sources; Design and develop workflows to link datasets in the data lake based on shared ontologies;

This position designs, develops and implements new products, processes, test methods and equipment. This position is responsible for conducting engineering studies for process improvements and validations. Initiates new or revised documentation and tracks through appropriate approval cycles and implementation. Maintains a professional working relationship with internal and external customers and support staff. Develops physical and functional test requirements to ensure specifications and regulations are met. Writes and approves protocols, reports and data.

This position is responsible for working in the Bard Complaint Laboratory to perform product testing as well as planning, organizing, and tracking work activities. Quality results are expected to ensure the integrity of Bard complaint investigations. Additionally, the Quality Engineer functions as a subject-matter resource for Engineering, Operations, Sterilization and outside suppliers. Responsible for all products testing in the Complaint Laboratory. Creates investigation files in the BARD Global complaint system (Trackwise).

The Manufacturing Chemist I is responsible for processing and formulation of controls, calibrators, working solutions, and intermediates according to approved standard operating procedures. Responsible for manufacturing quality products on schedule. General knowledge and basic application of concepts, theories, terminology and practices that apply to manufacturing in a laboratory environment.

Bio-Technical Resources is seeking an Assistant Research Scientist to work with supervision as a microbiologist and molecular biologistas part of a team developing new strains for the production of antibiotics, enzymes, metabolites, and proteins. The position involves generating and improving strains using strain engineering molecular biology techniques or classical mutagenesis,screening and selection.Routine microbiology tasks

The Sample Management Technician is responsible for GxP-compliant processing of incoming and outgoing samples and reference materials. Responsible for GxP-compliant accessioning of incoming samples and reference material, as well as the outgoing shipment of samples, reagents and reference materials. Reviews study sample demographic data to confirm consistency between the tube labels, study paperwork and electronic sample management systems (eSMS). Resolves discrepancies, with responsibility for investigating and correcting sample anomalies identified in the eSMS system.

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.

The responsibilities of this position are to purify proteins to restock the supply of existing products and modify existing protocols for larger scale production of proteins.  This position will require assistance with basic lab operations and routine guidance on how to follow SOP’s and purification methods.

As a part of our San Jose team, the successful applicant will work with other members of Consumables Production, as well as a multidisciplinary team of engineers and scientists, to support the assembly of microfluidic cartridges for biotech products. Operate and maintain cartridge fabrication process, with good manual dexterity. Perform in-process QC and record results. Microscope inspection of chips and microfluidic devices

The responsibilities of this position are to support the Quality Assurance function within Bio-Techne through quality systems development, quality systems auditing, documentation review, and other QA functions.

(Associate Level) Executes routine unit operations in Upstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures. Executes, with oversight of qualified staff, complex unit operations including but not limited to batching and inoculation of bioreactors, operation of bioreactors, process monitoring, and harvest operations. Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.

Non-Lab position. The Sample Management Technician is responsible for ensuring that all samples are entered into the Laboratory Information Management System (LIMS) and made available to the lab staff in a timely manner. This position reports to the manager of Stability and Sample Management. The Technician’s responsibilities include, but are not limited to, the following: Performs any combination of sample management tasks, including labeling, preparing for shipping, transporting to labs, inventorying and disposing. Reviews and verifies sample paperwork against samples to ensure accuracy and communicate discrepancies. Distributes sample information and paperwork.

The Process Engineer I is responsible for developing and maintaining capable processes and ensuring efficient and effective sterilization operation. This person will apply problem solving skills to enable sterilization innovation while using technical and collaboration skills alongside his/her passion for innovation and continuous improvement to drive growth through efficient and effective process improvements. Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on multiple and moderately complex processes. Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.

The Scientist will provide biologics process development support to ensure that the Brammer Bio Downstream Process Development (DSPD) unit operates to provide clients with new purification methods and investigational materials for pre-clinical and clinical use. The incumbent will assist in the design and execution of experiments under the supervision of the technical project lead. This will involve researching and sourcing reagents, equipment, and materials; preparing columns; purifying viral vectors utilizing working knowledge in filtration technologies, column chromatography (SEC, affinity, HIC, AEX), ultracentrifugation and scale up principles. This position will also be expected to technically review data, prepare experiments/data for presentation, participate in laboratory investigations, interpret this data and work with the project lead to trouble-shoot technical problems. The incumbent will participate in the optimization of purification methods and the writing and troubleshooting of protocols. The incumbent is expected to prepare and modify documents (SOPs, Batch Records, Raw Material Specifications, etc), maintain a GLP culture, and assist in maintaining the process development laboratory.

The primary responsibility is to support the technology transfer teams for the late stage, PPQ and commercial manufacturing of viral vectors. This position requires close interaction with the MS&T colleagues, Manufacturing, Process Development, and other departments. This role will focus on aspects of ensuring a robust, scalable and efficient manufacturing processes to produce late-phase human clinical trial and commercial gene transfer vector products. Supports cross functional technology transfer teams for cGMP DS manufacturing of viral vectors. Collaborate with another site or clients to ensure success of scale up/ process transfer. Includes authoring of upstream or downstream plan documentation and associated detail process descriptions (DPDs).

Responsibilities include: Conduct experiments to support cryogenics manufacturing processes of commercial and late-stage biologics drug substance. The candidate will support bulk container selection and freezing, storage, and thawing operations for biologics drug substance. Support validation of the freezing and thawing processes of commercial and late-stage biologics drug substance across BMS global network and contract storage/manufacturing sites. Follow appropriate GLP/GMP procedures. Study design, execution and analysis of results, data verification, preparation of study protocols and final reports, and the presentation of findings at internal and external forums

This associated scientist position within the analytical methods team has the opportunity to drive the development and validation of robust separation methods (e.g., CE-SDS, iCIEF, SEC, RP, IEX, HIC) for biotherapeutic drug candidates in the portfolio spanning early and late stage clinical programs. Bristol-Myers Squibb's biologics pipeline includes approved biologics products such as OPDIVO®, YERVOY®, EMPLICITI®, ORENCIA®, and NULOJIX®, and a number of exciting clinical stage compounds as well as antibody combination products. Development of methods utilizes state-of-the-art analytics as well as modern concepts of quality attribute monitoring of biotechnology products. Science-based research and molecular-level understanding of protein properties are critical for successfully performing method development. Innovation is central to establishing robust analytical control and define our overall biologics development strategy. The successful candidate will also support regulatory filing activities including IND and BLA, as necessary. This position reports to manager in Methods and Analytical Development function of the Biologics Development organization.

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 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 successful candidates will be integral in discovering and developing the next generation of therapies for hematological diseases. The successful candidates will have experience executing and analyzing in vivo experiments in hematology, specifically the hematopoietic and immune system. Basic cell and molecular biology skills are desirable.

Catalent has an entry level Associate, cGMP Manufacturing position available. As an Associate, cGMP Manufacturing (Good Manufacturing Practices) you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document cGMP Biomanufacturing activities. Shift position is Wednesday to Saturday (4/10) from 7:00 a.m. to 5:00 p.m. CST. 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).

As an Associate, Biomanufacturing you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) activities. This is a second shift position offering enticing compensation incentives. Work hours are Wednesday to Saturday (4/10). 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). Supports Biomanufacturing staff with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA) revisions, deviation investigations and change control/protocol execution, by established due dates. As an Associate, Biomanufacturing you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) activities. This is a second shift position offering enticing compensation incentives. Work hours are Wednesday to Saturday (4/10). 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). Supports Biomanufacturing staff with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA) revisions, deviation investigations and change control/protocol execution, by established due dates. As an Associate, Biomanufacturing you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) activities. This is a second shift position offering enticing compensation incentives. Work hours are Wednesday to Saturday (4/10). 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). Supports Biomanufacturing staff with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA) revisions, deviation investigations and change control/protocol execution, by established due dates.

The Solutions Prep, Associate I will perform aseptic techniques within in a clean room environment. Execute and properly document cGMP Biomanufacturing activities. The Solutions Prep, Associate I will operate cGMP Biomanufacturing equipment, including pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and analytical equipment as applicable. The position is expected to follow detailed instructions and established procedures with frequent supervision. Shift position is Sunday - Wednesday (4/10) from 7:00 a.m. to 5:30 p.m. CST. The Solutions Prep, Associate I will perform aseptic techniques within in a clean room environment. Execute and properly document cGMP Biomanufacturing activities. The Solutions Prep, Associate I will operate cGMP Biomanufacturing equipment, including pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and analytical equipment as applicable. The position is expected to follow detailed instructions and established procedures with frequent supervision. Shift position is Sunday - Wednesday (4/10) from 7:00 a.m. to 5:30 p.m. CST. The Solutions Prep, Associate I will perform aseptic techniques within in a clean room environment. Execute and properly document cGMP Biomanufacturing activities. The Solutions Prep, Associate I will operate cGMP Biomanufacturing equipment, including pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and analytical equipment as applicable. The position is expected to follow detailed instructions and established procedures with frequent supervision. Shift position is Sunday - Wednesday (4/10) from 7:00 a.m. to 5:30 p.m. CST.

As an Associate, Biomanufacturing you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) activities. This is a second shift position. Work hours are Sunday to Wednesday (4/10). Responsibilities include: 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). Supports Biomanufacturing staff with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA) revisions, deviation investigations and change control/protocol execution, by established due dates.

Catalent has an opening for a Laboratory Associate Buffer Preparation, Manufacturing position. Responsibilities will include performing aseptic techniques within a clean room environment. As the Laboratory Associate Buffer Preparation, Manufacturing you will learn to execute and properly document biomanufacturing activities. Work schedule is Wednesday to Saturday, 7:00 a.m. to 5:00 p.m. CST. 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).

The Formulation Tech reports to the Production Manager. The position is entry level and responsible for learning the basic BFS technology, personal protective equipment, equipment use, and comprehension of formulation processes and methods such as: tank sterilization process, temperature recorder function, reading set-up drawings, tank compounding, and batch record documentation. This position is responsible for aseptic gowning certification as prerequisite to entering the Aseptic Suites. New hire is not intended to stay in this position long term. Once training and qualification is completed at this level, employee advances to Formulation Technician Level 1.

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.

Responsibilities include: Verify Excel spreadsheets and calculations. Assist in paperwork routing, document assembly, and verification of information packet completeness. Verify raw data against information in Methods or Standard Operating Procedures: Ensure Compliance with general SOP requirements, Verify Solution composition or concentration, including calculations used to determine the concentrations are correct, Verify volumes used and any processing step documented are as explained in the sample processing procedures

Responsibilities as a manufacturing associate include: Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR). Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions. Maintain dry room and cleanroom standards, practices, and housekeeping according to standard operating procedures. Set up and operate manufacturing equipment. Monitor machines and inform Supervisor and/or Lead of problems. Clean and maintain equipment and work area as needed.

Cepheid is looking for a Software Engineer to join our product software team developing molecular diagnostics applications using Java and Angular predominantly. You will be a member of the software team responsible for designing, developing, testing, and implementation of Cepheid next generation software products. Repsonbilities include: Design, develop, troubleshoot and debug software products using Java and Angular. Maintain robust software applications by participating in software debugging and testing. Adhere to software development and source control processes.

Support in vivo oncology studies in mice as a member of the Veterinary Services Team. Conduct daily and weekly assessments and treatments of animals identified with abnormalities. Administer the health surveillance program as described, including animal and sample submission and tracking of results. Proficiently perform survival animal surgeries and provide perioperative care. Collect blood and tissue samples as dictated by study protocol or veterinary need

The position will work in the flow cytometry laboratory handling samples and preparing for flow cytometry evaluation. Perform standard cell biology techniques to process blood and tissue samples from multiple species. The laboratory process samples in a high-throughput, plate-based manner, requiring ability to use multichannel pipetting. Solid tissue and tumor samples will be dispersed into single cell suspensions. Samples may require cell counting and viability determination using cellometer, hemocytometer, flow cytometer, or other techniques. Sample handling may include cell washing, red blood cell depletion, stimulation, intracellular staining, fixation. Staining of samples with multicolor antibody cocktails. Some PBMC isolation and freezing down cells to create cell banks. Some tissue culture work may be required. He/she will follow SOPs and methods, and carefully record and document processes performed within the laboratory.

Support in vivo oncology studies in mice as a member of Cell Culture Team. Prepares passaged and primary cells for use by in vivo and in vitro technicians as directed. Produces, maintains and characterizes cultured cells, as directed. Performs related general duties such as inventorying supplies and reagents, general lab housekeeping, and maintaining safety records. Maintain accurate and detailed records using laboratory information management systems and Microsoft Office suite programs

Perform basic necropsy laboratory procedures. Participate in the documentation of all activities as required. Receive and ship samples. Assist with and perform basic necropsy procedures (basic dissection, tissue collection/preservation, fresh tissue trimming, sample collection, etc.). Learn/know correct anatomic terms. Receive samples, complete tracking documentation, and prepare pathology materials and data for shipment and archiving

We are seeking a Research Technician I for our Safety Assessment Group site located in Ashland, Ohio. Collect and record data with minimal supervision in the performance of studies. Responsible for handling and restraining animals, clinical observations, sample collection, monitoring food consumption, animal husbandry, and performing accurate data collection and reporting. Administer test substances by various basic methods.

In this position, the Laboratory Operations Technician I will be responsible for performing a variety of tasks involved in sample receiving and processing, and inventory management of critical components, laboratory supplies, specialty reagents, and client-supplied reagents and controls. Perform activities related to sample log in, processing, storage, shipping of materials client support, laboratory and facilities order placement, and order tracking, receiving, and processing.

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

Provide an overview of the responsibilities of the position by providing a summary of the most important aspects and duties of the position. This is an entry level position into Quality Assurance Operations. Developing responsibilities include assisting with investigating deviations, relevant to area of responsibility. Responsible for driving continuous improvement on production floor to ensure compliance to cGMPs. Real time review of batch records, including critical processing steps with production floor presence.

The incumbent will be a member of the QA-Engineering team at the Holly Springs Influenza Vaccine manufacturing facility, supporting QC/Bulk and/or Fill-Finish Operations. The QA-Engineering Specialist applies Seqirus quality principles related to equipment qualification, method validation, process validation, Cleaning validation, shipping validation and technology transfers. Utilizes integrated commissioning and qualification principles to ensure compliance of equipment and system qualification. Supports the development and maintenance of quality procedures and systems related to Quality Assurance oversight. Provides technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, and regulatory requirements.

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 Clinical Research Associate completes project activities associated with monitoring functions of phase I through phase IV clinical research studies while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP) and applicable local regulations; provides clinical and technical support for CRAs and administrative staff; and performs management of study site activities to ensure integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).

The Research Associate will work closely with colleagues in platform development, biology, and pharmacology. In addition, the Research Associate will be responsible for restocking lab supplies and maintaining lab equipment. Core responsibilities include: Conduct whole body perfusion and collect tissue for histological analysis. Micro dissect and process inner ear tissues. Perform immunohistochemistry staining protocols. etc.

This position will report to the Senior Scientist – Enzymology in the Lawrence, KS research facility. Key responsibilities include: Perform routine drug screening assays for kinase inhibitors. Quality control of high throughput screening equipment. Together with supervisor, responsible for validating new biochemical assays and troubleshooting when needed to establish reliable screening platforms. Track and record data into corporate database and notebooks. Generate reports and create presentations as required by the organization.

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.

An ideal candidate should have a background in immunology, cancer biology, and a strong interest in genome editing. Responsibilities include: Develop and optimize protocols for gene editing, including: delivery methods, culture conditions, scale up, and multiplexing. Culture primary cells and cell lines. Perform basic molecular biology work such as DNA and RNA extraction and PCR. Develop and perform immune cell activation, cytotoxicity, and other cellular and ELISA-based assays to evaluate gene editing approaches in cell therapeutics in vitro and in vivo. etc

The R&D Technician will support a wide range of engineering activities such as test, check-out, modification, fabrication and assembly under minimal supervision of Engineers and may propose technical solutions. Responsibilities include: Build complex prototypes, sub-assemblies, test samples, and prepare feasibility test units, samples, and/or chemical solutions. Perform complex work using drawings, diagrams, written and verbal instructions, layouts or defined plans to perform testing, checkout, and trouble-shooting functions.

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.

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.

Carries out routine experiments and procedures in accordance with all applicable regulatory (e.g. DEA, EPA, FDA, FIFRA, OECD, etc.) requirements as defined by protocol, method, and standard operating procedures (SOPs). Assist/run toxicology studies, including preparing test solutions and daily maintenance of test systems. Feed, water, and examine animals for signs of illness, disease, or injury sustained in the laboratory. Performs analysis, first level, and peer review of data for accuracy and completeness.

Responsibilities include: Develop, qualify and validate analytical test methods for drug products, intermediates and excipients. Design and execute analytical development studies. Write protocols and repors. Maintain and write SOPs. 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.

Responsibilities include: Assist with all aspects of EHS, including applicable OSHA regulations, environmental record keeping, safety audits, and accident investigations. Ensure the Emergency Response Plan remains current with regulatory requirements and site needs, assist with the readiness of FDBT personnel and facilities to respond to emergencies. Conduct environmental and safety audits and inspections; assist EHS Management with reporting to Senior Leadership.

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:

The Immunotherapy Technician I position will work under the close supervision of the Immunotherapy supervisor to carry out the following departmental responsibilities: aseptically filling immunotherapy vials and preparing all products for final packaging and shipment. This position will require the ability to multitask as well as follow standard operating procedures at all times. Performs aseptic hand filling operations, Prepares raw materials and filling operation set-up, Inventories all of the department raw materials and products, 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.

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 Process Technician will support the installation and qualification of a GMP continuous tablet manufacturing line, highly automated, with Process Analytical Technology enabled control. This position will also support the development and manufacturing activities for drug product and formulation development projects. Main responsibilities include: Work in a GMP environment area, executing chemical and physical operations following approved written instructions and in accordance with cGMPs and EHS regulations. Clean/verify proper cleaning of equipment and production areas according with cGMPs. Adhere to the necessary gowning requirements and in alignment with the various room classifications. Ensure that performed activities are recorded in applicable documentation.

The Quality Assurance Associate Specialist promotes high quality standards and a continuous improvement culture within the Quality area of the New Jersey site in order to ensure that these are aligned with applicable quality regulations and the company's high quality standards. This role provides support in achieving the department objectives and supports the cGMP programs (i.e. validation, qualification, stability, and environmental control). Main responsibilities include: Reviews completed batch records and associated deviations for final product release; Reviews executed protocols and other GMP related documentation; Responsible for evaluation/approval of equipment cleaning; Prepares SOPs, quality related reports, and change control documents when appropriate; 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.

Research Associate plays a pivotal role in our R & D teamwork on novel projects involving drug-device combinations for treating chronic diseases with the potential to dramatically impact patient outcomes. Responsibilities include: Independently carry out technical aspects of research projects including formulation work, sample preparation, conducting experiments, recording and managing data, and communicating results to supervisors and research team. Conduct bioanalytical assays and analyze data for the quantification of analytes. Record and manage data from complex experiments including preliminary statistical analysis

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.

Assists with preparation of autoimmune diagnostic Immunofluorescence Assay (IFA) slide, control and conjugate products in accordance with established procedures. Major duties include preparation activities for IFA controls and conjugates and the growth of cloned antigens in insect cells. Maintains detailed Device History Records, laboratory notebooks and/or any associated documentation for all manufacturing and evaluation activities in accordance with current Quality Systems Regulations (QSRs). Tests IFA slide products for acceptable titer and pattern reactivity according to written Manufacturing Documents. Assists with the maintenance and growth of insect cells and the harvesting of various cloned antigens from these cells according to established procedures.

As a member of the Technical Support Team, provides product and technical support to customers via phone and email on all Inova products. Responsible for assessing customers’ needs and delivering exceptional customer service to provide remote support, basic troubleshooting, and issue resolution for Inova customers. Responds to customer product inquires on a broad range of technical questions regarding instrument and assay performance, instrument capabilities, quality control, and other product concerns. Interpersonal skills and technical product knowledge, judgement and decision making expertise are critical to responding to daily customer-centric activities.

Participate in cross-functional project teams to implement creative solutions. Monitors performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues. Interfaces with Quality and R&D to integrate new products or processes. Responsible for identifying and correcting manufacturing process nonconformance's identified during prototype builds. 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.

Position summary: Perform most of the tasks and procedures required to ensure the timely and efficient processing of jobs through the manufacturing area. Maintain and update production and material control systems as needed to ensure proper job and material tracking is maintained. Maintain work area and equipment in a clean, neat, and organized fashion. Complete off-schedule notifications.

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)

We are currently seeking a QC associate to work in both laboratory and cleanroom environments under strict SOP’s for performing environmental monitoring and other lab testing. Responsibilities include; sampling using EM equipment, sample handling, testing, reporting results with accurate documentation, investigation of OOS’s, and determination of root cause as appropriate

Manufacturing Associate will be responsible for the manufacture of pre-clinical/clinical products. Responsibilities include: Operates the production processes according to the determined daily production planning. Performs defined production processes according to GMP and SOP procedures (e.g., set-up, machine handling, close down, reconciliation,line cleaning, line clearance, waste disposal, storage, etc.).

The Clinical Territory Associate (CTA) will work closely with the Clinical Sales Manager to gain knowledge in all aspects of our business to include technical, clinical, and sales. He or She will train to be a da Vinci® Surgery technical and sales expert across all primary surgical specialties to develop surgical robotics programs in the assigned territory. During the first year of the job, the CTA will focus on the technical and clinical aspect of the job, and during the second year of the job, the CTA will progress and begin to focus on the sales aspect of the job. The CTA will have the opportunity to support a specific region by maximizing the utilization of installed da Vinci® Surgical Systems by leading product demonstrations/in-services and sales activities.

As part of the pipeline engineering team, you will be responsible for maintaining, improving, and adding to our catalog of production bioinformatics pipelines across an expanding set of modern assays. You will be responsible for scaling our pipelines as we work toward our goal of providing low-cost genetic answers to billions of people. You will work and learn among an extraordinary set of peers: bioinformaticians, molecular biologists, and software engineers. Your work will directly improve the quality of our product and positively impact each tested patient.

As part of our Assay Tools team, you will help ensure that we can grow the breadth and scale of genetic tests on our menu. You will apply your knowledge of computer science, statistics, and NGS to analyze, improve, and develop an expanding set of modern assays. You will work and learn among an extraordinary set of peers: bioinformaticians, molecular biologists, and software engineers. Your work will directly impact early development work focused on improving the quality and capability of our products.

The Project Coordinator provides support to the Project Manager and related team members by performing generic procedures and tasks associated with the day to day running of projects throughout the entire study lifecycle (e.g. startup, maintenance and close-out); Ensure work is conducted in line with standard operating procedures, policies and good practices. Oversee and manage the timely closure of queries and work with the internal applicable teams or functional areas where applicable (examples may include, the Global Delivery Network, Contact Center or being the point of contact for client personnel to assist with service queries, including related to investigator reports).

The primary objective of the sale representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus.

The Quality Assurance department is devoted to assuring safe, reliable and effective products that exceed patient, physician and hospital/clinic expectations. The department plays a vital role in product and process quality supporting commercial production for all Iridex products including laser consoles, delivery devices and accessories. The Quality Engineer (QE) works with a team of dedicated individuals supporting new product development and manufacturing operations to assure quality of finished product and identify quality issues related to electrical, mechanical and software subsystems. The QE evaluates product quality issues, performs root cause analysis, identifies remedial actions and follows up to ensure all actions are completed satisfactorily prior to resolution and closure.

Responsibilities inlcude: Utilize chromatography data systems and informatics platforms to analyze and distribute analytical results. The successful candidate will have some experience in chromatography, electrophoresis, and analytical chemistry. Experience with high throughput analytical testing, statistical analysis and high-performance liquid chromatography is a plus. The ideal candidate has strong written and verbal communications skills and works well independently and in teams.

Duties include: Process submitted samples into forms ready for analysis, such as grinding solid samples to a homogeneous mixture. Perform routine laboratory chemical analyses and/or instrumental test procedures using standard methods of analysis, and then calculate and report the assay results. Prepare and maintain chemicals, chemical solutions, sample dilutions, and equipment as needed for the performance of analyses. Maintain accurate records and documentation and assure the reliability of measurement systems by using appropriate GLP.

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.

The Molecular Technologist will be responsible for performing complex molecular testing and results analysis according to established standard operating procedures. The Integrated Genetics-Westborough site processes extracted DNA from peripheral blood and prenatal samples (amniotic fluid and chorionic villi) for genetic testing. A variety of molecular genetics techniques are used to include Next Generation Sequencing, real time PCR, Sanger Sequencing and Southern Blot analysis to test for specific genetic diseases such as cystic fibrosis, spinal muscular atrophy and Fragile X syndrome to name just a few.

The Lab Support Technician will be responsible for performing clinical specimen accessioning, sample sorting, and data entry in a fast-paced, high-throughput environment according to established standard operating procedures. Please note, this position does not involve any actual hands on lab work. The role is primarily focused on accessioning, data entry, and supporting the laboratory. The schedule for this position will be Tuesday-Saturday, 9:30am-6:00pm. Saturday hours are 7:00am-3:30pm. Responsibilities: * Open incoming packages from clients, unpack and receive specimens * Perform data entry and Quality Assurance for specimen/patient information with a high degree of accuracy and in accordance with established protocols

Perform repetitive line assembly operations to produce on-site drug test kits in accordance with Standard Operating Procedures.Make sure the proper paperwork is completed.

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.

As a member of the Lentigen Technology team, you will have the opportunity to perform duties within the area of infectious disease research and development. This includes genetic manipulation of viral vectors, immune cells and working with live HIV-1 as it relates to HIV Immunotherapy.  Furthermore, you will be responsible for designing specific experiments relevant to HIV Immunotherapy and analyzing the data using appropriate statistical methods.

You will use Lentigen’s expertise in lentiviral vector technology to analyze the biology of immune effector cells, stem cells and immortalized cell lines modified by lentiviral transduction. Furthermore, the unique duties of this position will allow you to master state of the art research and development techniques in molecular biology, lentiviral technology, genomics and immunology to make valuable contributions in keeping Lentigen Technologies, Inc. at the cutting edge of biomedical research.

The Therapeutic Production Chemist is responsible for performing manufacturing activities in compliance with company procedures and external regulatory requirements as directed by the departmental supervisor, manager or director. The Therapeutic Production Chemist will work closely with experienced group members and may interact with other LGC facilities to support GMP activities, such as produce and release GMP batches.

The Machine Operator I is responsible for the setup and operation of standard packaging machinery in the packaging department.  This includes working with and monitoring other packaging personnel to complete equipment set up and operation required by the department schedule. Machine Operators must comply with regulatory requirements, Good Manufacturing Practices (GMP), Standard Operating Procedures (SOP), and Manufacturing Process Records (MPR). They will perform all processes as required to fill, label, print, tray seal, pouch, final package, and inspect any Lifecore product; document completed work during packaging of final product; continually practice proper precautions and procedures when working with equipment and handling chemicals; participate in the review of batch records, etc.

Successful candidates will have basic knowledge of biochemistry and molecular biology techniques, in particular experience with, protein expression andpurification and cloning. Knowledge of the ubiquitin proteasome pathwayis desired.

Associate scientist needed in the area of pharmaceutical drug delivery research. Responsibilities include conducting laboratory experiments in support of formulation and process development. Knowledge of laboratory practices and demonstrated skills in analytical instrumental techniques (e.g. HPLC) are preferred. Excellent communication skills needed for preparing and following standard test methods and reporting experimental results.

We are looking for only the most driven Electrical Engineers with solid engineering fundamentals. Responsibilities include: Circuit simulation/modeling, Bench data collection, Scripting & overall test automation, Chipset evaluations (e.g Bluetooth, MCUs, accelerometers…), PCB design & layout, etc.

The Manufacturing Associate Level I (Night-Shift) is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.

The Lab Technician in the Blend Test Services Department is responsible for all facets of testing from the set-up and take-down to reporting of results. The majority of the workday is spent in a laboratory setting working with new and used oils, solvents, chemicals and equipment utilized to complete testing. This person is responsible for ensuring safety, quality, and timely delivery of test results while using good housekeeping practices during daily operations. Conduct quality tests following work instructions and ISO 9001 and ISO 17025 procedures. Ensure that all test protocols are in compliance with recognized industry or internal LZ test standards. Update work instructions and procedures as necessary. Plot reference data on control charts. Understand control charting and when to investigate potential issues. Must be able to identify, troubleshoot, and work closely with chemists and business partners to resolve issues or problems. Appropriately elevate the situation to chemist, manager and/or business partner when necessary.

The Reagent QC Associate assists with duties that span a broad range of activities within the quality control operations at Luminex. The selected candidate will be primarily responsible for Quality Control testing with the primary focus on raw material inspection, and in-process and final product testing. Responsibilities include: Performing assays for release of raw materials and products, and method validations . Complete appropriate documentation and data entry as required by procedures and tests performed. Reviewing and improving SOPs

The Manufacturing Assembly Associate Level 1 will be responsible for : The assembly, integration of mechanical, fluidic, electronic, optical and electro-mechanical systems. System integration testing and troubleshooting for all products in of support quality manufacturing production as a typical day to day requirement. Product knowledge, documentation transfer, training and inter-departmental communication also required. Performing assigned tasks that utilize their interdisciplinary skills to perform integration troubleshooting and assigned field service tasks. Performing set-up, calibration and operation of automated and semi-automated production equipment and fixtures, based on work area.

This is an entry level position. The Applications Engineer will be responsible for testing and analysis of customer samples for feasibility and performance of our terahertz equipment. With increasing familiarity and experience with our product line the Applications Engineer may assist with customer training, field trials of the developed applications, and the installation and/or minor servicing of gauging solutions at the customer’s facility. The Application Engineer will provide remote hardware/software support to customers located within the United States. Remote and onsite services/support will include install, repair and troubleshooting of terahertz gauging software and equipment found within an industrial environment.

The Quality Tech II analyzes process samples as received and performs non-routine analysis as requested. She/he will analyze finished goods and raw materials by chemical, physical, and instrumental means to ensure quality as needed. This position will be on a rotating schedule. Performs specified analysis on all process controls samples and reports in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques. Performs specified analysis on all finished goods using approved written procedures and proper laboratory techniques as needed.

Looking for an ECG interpreter, for our San Francisco, CA office, who is excited about having the front line responsibility of triaging the patients who have our life-saving products prescribed to them. Responsibilities include: Receiving ambulatory ECG data from phone and web transmissions. Making the correct arrhythmia call, not just knowing where to place the electrodes. Using proprietary software to efficiently compose arrhythmia reports for physicians, etc

Looking for an ECG interpreter, for our Burtonsville, Maryland office, who is excited about having the front line responsibility of triaging the patients who have our life-saving products prescribed to them. Responsibilities include: Receiving ambulatory ECG data from phone and web transmissions. Making the correct arrhythmia call, not just knowing where to place the electrodes. Using proprietary software to efficiently compose arrhythmia reports for physician. etc.

Responsible for the deployment and maintenance for critical enterprise systems within a cloud Infrastructure. Serves as a technical resource for system administration of applications, operating systems, virtual machines, containers and network infrastructure. Manages and adheres to standard configuration and deployment of applications, operating systems, and network infrastructure. Investigates and analyzes system requirements and system specifications.  Provides leadership and management to deliver the highest level of service to all system users.  

Your primary role is driving conceptualization, development, and prototyping of new product concepts, focused on inventive uses of new and existing technologies that open up entirely new product concepts. Work hours and days are extremely flexible, based on need and your availability. Integrate Industrial Design Techniques to Create Designs with Improved Aesthetics, Ergonomics, and Usability. Select and Integrate Proper Materials, Components, Technologies, and Assembly/Manufacturing Processes.

Responsibilities may include the following: Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.

You will serve as an individual contributor by providing support for the new product development and sustaining projects. The individual will assist the business in interpreting and executing against Medtronic quality system elements including software/system work products to ensure compliance. This individual will ensure that all system-level project / program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronic’s quality, reliability, and compliance requirements. This individual will ensure Design Quality Assurance-driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes.

As an Associate Supplier Quality Engineer, you will be responsible for:  Providing support to Operations and Receiving inspection teams in all areas of production quality assurance. Ensure components received in Miami lakes meet specifications, works with suppliers to investigate root cause and provide sound corrective actions in a fashion manner. May participate in supplier process development, supplier management, and maintaining supplier files. 

Specific to Environmental and Utility Monitoring, the Analyst will be responsible for maintaining the EM program to include the following: Collection and testing of qualified Utility systems including Clean Steam, WFI and compressed gasses. Execute environmental sampling of Classified Areas including active air sampling, surface sampling and non-viable air sampling. Provide data entry, review and approval as required. Provide summaries of test results to appropriate personnel as needed

The successful candidate will be expected to work as part of a team that is focused on the development of vaccine drug products.  The main responsibilities include the design and execution of experiments to evaluate the impact of formulation composition and the manufacturing process on yield and stability of liquid and lyophilized vaccine drug products. The successful candidate will have formulation and/or process development experience with large molecules. They should possess scientific knowledge and/or experience related to biophysical characterization, lyophilization or other drying technologies, and immunology. Effective oral and written communication skills and the ability to learn new skills quickly are essential.

Under the supervision of the Laboratory Supervisor, Senior Supervisor, Area Head or Laboratory Manager, consult with supervision concerning the planning of and perform testing on raw materials, culture media, production intermediates, manufactured bulks, finished products and/or other samples in compliance with written procedures. Testing may be performed in one or more of the following scientific disciplines: Microbiology, Biochemistry, and/or Virology. Read, record, review and calculate test results and may be required to assist in the approval/validation of test data generated according to written procedures. Assist in the revision/implementation of control procedures (CPs) and standard operating procedures (SOPs) within the department and assist in training and orientation of other Laboratory Technicians.

At MilliporeSigma the Planning & Scheduling Specialist reviews demand plans at a global and local level including adjusting forecast and safety stock parameters.  He/she will also work with the sales group to incorporate customer demands into the planning systems and will develop operational schedules to meet customer service objectives and support sales growth plans at the lowest overall inventory costs.  The specialist will also develop, test and execute models for scheduling operation and lead and/or assist process improvement initiatives.  In addition, he/she will review long term plans to ensure capacity requirements are understood and met and will compile reports and metrics to ensure business has proper feedback loops on performance to objectives.

Manufacture or evaluate products according to established protocols, provide technical support to others and perform operations in support of the group and department. Manufacture or evaluate products according to established protocols, provide technical support to others and perform operations in support of the group and department. Ensure quality throughout the process. Assure you are adequately trained to perform tasks/assignments. Perform routine assays, processes and/or unit operations. Contribute to support functions of the lab (e.g., maintain equipment, prepare reagents, restock lab supplies, waste disposal).

Must have good laboratory habits and be able to follow SOPs, procedures and protocols. Able to multi-task, handle routine as well as non-routine requests and assist other members of the group as required. Familiar with established laboratory procedures.  Able to carry out experiments under close supervision. Possesses excellent record keeping skills, good written and verbal communications skills, and interacts effectively with peers and with people outside of the group. Able to work effectively with others to complete collaborative projects.

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.

Work as a member of a team to receive and log in client samples to prepare them for analysis. Review samples and documentation to assign identification numbers and enter data into our tracking system. Prepare packages for shipping and pick up by vendors. Contact clients when necessary to confirm information about test codes and sample contents. Achieve accurate, timely and consistent results to ensure samples are processed correctly

Work as a member of a team to receive and log in client samples to prepare them for analysis. Review samples and documentation to assign identification numbers and enter data into our tracking system. Prepare packages for shipping and pick up by vendors. Contact clients when necessary to confirm information about test codes and sample contents. Achieve accurate, timely and consistent results to ensure samples are processed correctly

We are looking for data entry specialists with 1-2 years of experience in data entry. Fast paced work environment will require at least 60 WPM and moderate computer skills to fulfill job duties

The Engineer – Calibration and Reliability is mainly responsible for the integrity of the calibration process and to ensure all documentation and procedures are up-to-date and cover all regulatory requirements. Other responsibilities include the improvement of asset reliability through predictive maintenance, analysis of data collected, risk assessments or other reliability related techniques or processes.

Responsibilities include: Drive efforts to design, develop, validate, and continuously improve manufacturing processes. Develop & define production control methods to monitor process output and establish critical supplier metrics. Define and coordinate the design and development of manufacturing fixturing and test equipment. Coordinate with R&D to optimize the design for manufacturing and reliability.

The Regulatory Affairs Associate supports the regulatory activities for development projects including new products and life cycle management. This includes assisting with regulatory strategies and timelines as well as the development and implementation of submissions under the direction of a line manager. With support from Regulatory Affairs Manager, provide ongoing support to cross functional teams to provide regulatory strategies during product development.

Responsibilities will include various system engineering activities for the PTS-250 development, including, but not limited to: 1. Responsible for design, development, integration and testing of various tasks in support of the PTS Software development effort. 2. Work with engineers from the various project teams in order to develop the PTS-250 software. 3. Work with quality engineering to develop test plans. 4. Responsible for design documentation.Responsibilities will include various system engineering activities for the PTS-250 development, including, but not limited to: 1. Responsible for design, development, integration and testing of various tasks in support of the PTS Software development effort. 2. Work with engineers from the various project teams in order to develop the PTS-250 software. 3. Work with quality engineering to develop test plans. 4. Responsible for design documentation.Responsibilities will include various system engineering activities for the PTS-250 development, including, but not limited to: 1. Responsible for design, development, integration and testing of various tasks in support of the PTS Software development effort. 2. Work with engineers from the various project teams in order to develop the PTS-250 software. 3. Work with quality engineering to develop test plans. 4. Responsible for design documentation.

Individual will be responsible for implementing clinical research protocols.

There are two openings. These positions are responsible for basic and routine tasks involved in the manufacture and assembly of the company's disposable test cartridges. Follow written procedures for set-up, operation, and clean up of manufacturing equipments, final assembly, and packaging. Responsible for manual tasks including, pipette solution, pouch and box labeling, product inspection. Prepare materials used in the cartridge production process.

The Flexible Resource Associate Scientist conducts pre-designed assays, makes scientific observations, maintains detailed workbooks and ensures all documentation fulfills generally accepted GLP or GMP industry standards. Functional area and period of deployment to a specific laboratory will be controlled via Sales and Operations Planning process. An individual able to follow the SOPs, protocols and relevant compliance regulations regarding safety procedures, documentation and scientific responsibility. You can maintain an understanding of technological principles and applications of the organization’s services; independently analyze data, interpret results and advise the supervisor and study director of any factors that may affect quality and usefulness of data.

As a member of the Miltenyi Biotec Manufacturing team, you will have the exciting opportunity to participate in both the manufacture and process development of T-cells and multiple other cell therapy products within a GMP environment. 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.

As a key member of the Miltenyi Biotec Accounting team, you will provide accounts payable and accounts receivable support including collecting and posting payments, assisting in debits and credits when needed, reconciling back-up documents to invoices, processing invoices through receipt and account verification, maintaining vendor and accounting files, and preparing and verifying bank deposits. Within this role, you will perform month end duties as required inclusive of GL review and journal entries, as well as providing general administrative support.

As a member of the Miltenyi Biotec Manufacturing team, you will have the exciting opportunity to participate in both the manufacture and process development of T-cells and multiple other cell therapy products within a GMP environment. 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.

As a key member of the Miltenyi Biotec Accounting team, you will provide accounts payable and accounts receivable support including collecting and posting payments, assisting in debits and credits when needed, reconciling back-up documents to invoices, processing invoices through receipt and account verification, maintaining vendor and accounting files, and preparing and verifying bank deposits. Within this role, you will perform month end duties as required inclusive of GL review and journal entries, as well as providing general administrative support.

One year general work experience or equivalent education. Ability to read and understand documents such as policy manuals, safety rules, operating and maintenance instructions, and procedure manuals; Ability to write routine reports and correspondence. Ability to effectively communicate information and respond to questions in person-to-person and small group situations with customers, clients, general public and other employees of the organization.

Operates machines, tends the tablet press, transfers products into containers, weighs, mixes materials, records documentation, and performs basic routine maintenance. Cleans equipment and rooms per SOP’s and monitors product quality. Verifies all batches by control number, part number, and quantity per specifications prior to running the lot. Starts machine and observes operation to ensure all machinery is operating properly. Stops machine and reports any malfunction to Tableting Lead. Assist in repairs. Performs set-up of tablet press, assigned preventive maintenance procedures, parts assembly, and cleaning hardware. Ensures each product is tableted according to specifications and standard operating procedures.

Moderna is seeking a highly skilled and motivated Engineer I/II in Sterile Product Technology, a process development team residing in Moderna’s Technical Development organization, to support mRNA lipid nanoparticle (LNP) process development that enables our clinical supply. The applicant will play a critical role helping bring medicines to patients as Moderna’s portfolio begins to shift towards late-stage development. The primary role for this position will be to support fill/finish process development and scale-up work, with eventual ownership of experimental design and execution. The applicant will collaborate closely with Technical Development, Pre-clinical and GMP Production, Quality, and Drug Product Analytical Development groups on innovative process development efforts. Applicants should have relevant pharmaceutical experience with fill/finish processes and drug product development.

The primary responsibilities of this role will be to support implementation of analytical methods and routine testing messenger RNA therapeutic drug substances and drug products, including both chemical separation and biophysical techniques.  The incumbent will be expected to undertake laboratory work to support in-process sample testing of critical non-GMP large scale batches including IND enabling drug substance and drug product batches.   The analyst will be responsible for generation and reporting of analytical results.  

The individual in this role will be responsible for production of DNA for all constructs using custom automation, Hamilton liquid Handlers, and chromatography solutions. The successful candidate must demonstrate the ability to quickly master new processes and the drive to be part of a dynamic, fast paced, and highly motivated team. They must have training in chromatography (UPLC/HPLC), liquid handlers, basic molecular biology techniques, and ability to work with custom automation. The anticipated time frame for this assignment is 6 months.

Molecular Templates is seeking a highly-motivated and skilled Research Associate to support research and development activities. The position will be primarily responsible for ETB protein production and analysis in accordance to established protocols, and performing general laboratory duties, including solution and media prep, labware sterilization, ordering supplies, and maintaining inventory and basic laboratory equipment. This position will require excellent technical, analytical, time management and organizational skills, along with adherence to written and verbal instructions and accurate and timely completion of documentation.

Molecular Templates is seeking a highly-motivated and skilled Research Associate to support downstream processing for Protein Sciences. This position will perform functions related to production of pre-clinical drug product and early-stage process development for protein sciences, including routine protein purification, equipment maintenance checks and calibration, data management, and assist in review and development methods and procedures to control or modify the process. This position will also aid in identifying continuous process improvement areas.

Molecular Templates is seeking an experienced and highly-motivated professional to support downstream processing for manufacturing activities. This position will perform functions related to production and manufacturing operations, including routine protein purification, equipment maintenance checks and calibration, data management, and assist in review and development methods and procedures to control or modify the manufacturing process. This position will also aid in identifying continuous process improvement areas.

Expand the Life Sciences business with research reagents for the fields of biochemistry, molecular biology, immunology, cell biology and neuroscience. Identify new product and market opportunities and deliver exceptional product technical support, answer questions regarding our products and present our products in the most favorable and understandable form to influence the buying decisions of our customers. Continually follow market trends and identify new sales potential through the addition of new products and application focused on select market segments.

. The successful candidate will work both independently and collaboratively as part of the Cell Biology team. Perform a diverse range of cell-based assays to characterize lead candidates for various therapeutic mechanisms. Expand and differentiate human iPSCs towards the cardiovascular lineage. Execute a range of experiments using molecular biology and cell biology techniques including nucleic acid and protein isolation, qPCR, virus preparation, and metabolic assays. Manage aspects of housekeeping for the cell culture lab, including preparing reagents, helping with room maintenance, ordering and restocking.

Principle duties/responsibilities include: May perform routine test article/product preparation and execute routine testing and perform routine calculations per NAMSA SOPs and work instructions. Accurately collects and records raw data in logbooks and on worksheets. May be responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures. May be required to perform personal gowning environmental testing, and submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing as applicable.

Primarily involved in the welfare and husbandry activities of animals, including sanitation of equipment and the vivarium. Receives, identifies, and acclimates laboratory animals. Follows the Quality Manual, all NAMSA SOPs, and Process documents. Documents all required tasks. May administer treatments as directed by staff veterinarian.

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.

The Research Associate (Cell Culture Technician) will assist scientist/senior research associate for the culturing, plating, distribution, maintenance, and banking of cell culture lines. Important aspects of this role include excellent organization skills, flexibility, and the ability to thrive in an efficient, highly interactive, goal-oriented team environment, and working with minimal supervision. As a team member of the cell culture group you will work to support cell and tissue culture activities. The laboratory skills and training include expertise in mammalian cell culture, aseptic technique, sterile media preparation, tissue culture room maintenance, routine testing for endotoxin and mycoplasma.

The successful candidate will work as part of the innovation team of NantKwest to develop next generation products for adoptive cell therapy based on the allogeneic Natural Killer (NK) platform NK-92 . Perform research and associated laboratory tasks for projects and products. Work with other scientists to design and conduct experiments on a daily basis. Design and execute experiments with minimal guidance and supervision

The Research Technician performs routine laboratory research and development services. Works with a multidisciplinary team. Under nominal direction, performs a variety of basic and general laboratory research and sample management tasks determined by the field and scope of the research project. 

Analyzes specimens and maintains equipment in good operating condition. Verify the proper specimen being analyzed and perform tests that need to be completed. Analyze clinical laboratory specimens following the standard methods and procedures in an efficient manner with little to no errors. Responsible for maintaining updated understanding and knowledge of methods performed in the lab. Follows GLP (good laboratory practice): maintain clean and organized work space. etc.

Production Engineer - Statistics performs basic data analysis to manage daily operations for the product and its algorithms. Manage daily operations for the product algorithms. Track issues, coordinate new feature releases, and provide data analysis support to laboratory operations. Interface effectively with cross-functional teams within the company, including lab operations and software engineering. Be the "go to" person for data and algorithms issues. Track ongoing product performance metrics and investigate any variations, in cooperation with lab operations.

Perform transactions on corporate computer inventory control system and customer relations database based on requirements of the position. Provide important data to management for regular reports. Prepare tested assemblies for customer. Develop and/or design test processes/procedures based on product specifications. Proactively problem solves departmental related issues independently and mentors other technicians in this process

Responsiblities include: Test and calibrate assemblies to meet quality standards as well as perform electronic calibration and verify fixtures. Trouble shoot assemblies independently with exceptional computer skills. Maintain a strong commitment to high quality work with less than 2% failure rate on repairs. Maintain a 10 business day repair turnaround time on customer owned properties. Maintain minimum stock with refurbished parts to assure same day order fulfillment to assure best in class customer satisfaction

The Laboratory Analyst conducts testing in accordance with established procedures using Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and under the supervision of the Study Director. Additionally, Laboratory Analysts record data concurrently, maintain traceability of samples throughout testing and notify the Study Director of any unforeseen circumstances that occur during testing.

Responsible for preparing, executing and finalizing test method validations, equipment, system and utility IQ, OQ and PQs as well as maintain control charts.  Also, required to maintain the re-qualification schedule per the current validation master plan schedule.

The ideal candidate will have a B.S. in a science discipline, good communication skills including customer interaction, strong work ethic and laboratory experience is a plus. The selected candidate will manage the on-line sample analysis request program and log in samples received, analyze samples with Neogen’s test kits, according to kit instructions, generates and analyzes data from a variety of laboratory techniques and analytical instrumentation, calibrate analytical instrumentation and ensure all lab equipment is up to date per ISO requirements, perform tasks essential to maintaining ISO Certification, participate in sample proficiency programs, tabulates and graphs data, and prepares technical reports for senior personnel.

Establish and maintain customer portals for PO entry and invoicing. Direct contact with customers and work closely with company Data Administrator, IT, Accounting, Customer System Information Manager, and CS Manager to provide requested services from customer. Oversee customer complaint database (CMS) – from entry to resolution.

Assembles and packages diagnostic test kits used in the food safety industry according to Standard Operating Procedures ensuring accuracy and quality throughout the assembly process. Dispense bulk solutions and blended powders into final product packaging. Complete production paperwork, including quantities produced, scrapped and in-process.

Work with Engineering, R&D, and external subcontractors to develop test methods and execute testing used in the verification and validation of designs. This includes the design and fabrication of test jigs and equipment suitable for the characteristics being tested. This also includes the drafting of protocols and reports that adequately summarize the testing performed and are suitable for review by the appropriate regulatory authorities. Participateas part of a team undertaking all phases of the development process –from planning and proof-of-concept activities through to product launch

Manufacturing Associate, Labeling and Packaging are required to have a strong knowledge of process development experience, work flow understanding, Labeling Reconciliation, Reading and Understanding Labeling and Packaging Specifications. Carry out work in accordance with defined Quality Management System procedures and be fully supportive of Quality initiatives. Prepare room for staging, packaging, and reconciliation. Assist in maintaining fixtures, packaging tools, packaging instrumentation, such as scanners, scales, etc. in packaging areas.

he ideal candidate must have outstanding written and verbal communication skills, a strong work ethic, and be able to multitask and prioritize responsibilities. The position requires a working knowledge of many automated components of the HTS platform utilized at Neurocrine. This candidate must be able to independently manage their workload, while simultaneously working with his/her supervisor to provide consistent support to the in vitro team on multiple new target screening and lead optimization campaigns.

The Manufacturing Engineer is responsible for supporting all aspects of Manufacturing Operations at NeuroPace. Maintain quality standards in and around manufacturing areas, ensuring a safe work environment for all personnel and helps to develop a culture of accountability, continuous improvement, and collaboration. Write, review, and improve manufacturing procedures and forms in compliance with the quality system, ensuring accuracy and consistency. Collaborate with Manufacturing and Development Engineers to create, review, and maintain manufacturing routers. Including verifying manufacturing labor times are properly calculated.

The Regulatory Operations Senior Associate will be responsible for maintaining timelines, formatting & publishing documents, assembling and building Regulatory eCTD submissions such as original INDs, IND amendments and/or CTAs and overseeing & archiving submissions. All will be done in accordance with and requires knowledge in applicable Regulatory Agency regulations, guidelines, and/or specifications (FDA, EMA, ICH, etc). Responsible for formatting, editing, proofing, bookmarking and internal document hyperlinks according to guidance and internal processes. Troubleshoot and resolve complex document issues.

We are currently offering a unique opportunity for a highly motivated development associate to join our team with development experience in cell therapy. Responsibilities include: Support process development of phase appropriate cell therapy production processes. Evaluate raw materials and culture systems for use in cell therapy manufacturing processes. Support process optimization efforts to increase process robustness, reduce costs and improve yield. Design and execute experiments independently; accurately record, analyze and communicate data to senior staff and team members

The Operator is responsible for operating medical balloon machines and for 100% inspection of each medical balloon produced. Understand the need to deliver quality product and demonstrate a commitment to quality. Contribute to continuous improvement and Lean initiatives. Follow controlled environment protocols for hygiene and gowning. Maintain regular attendance. Operate medical balloon machines with simple process / materials such as PET, Nylon, and Urethane

Position consists of manufacturing of medical components in a clean room environment while under general supervision in accordance with specifications and written procedures. This position may include machine operation, manual production using hand tools, visual inspection, physical measurements, and packaging of finished product. This position requires the ability to work with small and delicate components using a high degree of dexterity and accuracy.

Electrical and mechanical aptitude with the ability to design, fabricate and wire electrical control panels and test fixtures. Troubleshoot and repair circuit boards and electronic assemblies to the component level. Write comprehensive documentation on tester hardware and software designs. Develop work instructions for system users. Provide troubleshooting support to engineering and assembly teams on products and processes

coordinates the development and implementation of the quality system, researching, developing and implementing process improvements necessary to eliminate waste and reduce inventory. Responsible for development of the performance metric system used to report on continous process improvements.

The Method Development and Analytical Services (MDAS) Research Associate is an experienced resource in performing sample testing and validating the methods necessary to support development and commercialization of pharmaceutical products. The MDAS Research Associate is responsible for performing the bench chemistry testing of pharmaceutical products supporting development of new products, incoming transfer of existing products, and analytical support of product life cycle management. The MDAS Research Associate will assist in performing method development, transfer, validation, and/or verification for methods related to analyzing raw materials, semi-finished/finished products, and stability. Customer communication and active participation as the analytical chemistry expert on work teams may be required.

The Chemical Filling Operator ( Second Shift) is responsible for the proper filling, sealing and labeling of various reagents. Responsibilities: Monitoring and maintenance of the filling equipment during operation, recording necessary data into procedures, inspection of product, loading/unloading product from equipment and movement of materials.

Responsible for providing a high level of animal care and husbandry, performing regularly scheduled facility maintenance tasks, and contributing technical assistance to research projects in the NNRC rodent facility. Reports to Manager, Animal Research. Internal relationships include working with Animal Technician, Attending Veterinarian, Lab Operations Specialist, Research Associates and Research Scientists locally and globally.

We are seeking to hire an entry-level microbiologist. The positionwill involveworking with a team of scientists to discover new antibiotics from newly cultured species from soil and marine environments. The work will include special projects as well as daily lab tasks such as reagent prep,record keeping, and equipment maintenance.

The Pharmacy Technician will be responsible for assisting the Pharmacy Manager with all aspects of drug handling and storage to assure drug availability and correct dosing according to the protocol.  Responsible for handling the receipt, storage, and return to sponsor along with test articles used in clinical studies.  Responsible for maintaining daily records of storage conditions of drugs and refrigerator temperatures.  Will prepare dosage forms for clinical investigators and provide general support to the clinical operations department.

We are seeking a talented and highly motivated scientist to join our Library Discovery team and help us augment our DNA encoded library collection. DEL synthesis requires a hybrid of techniques that are borrowed from chemistry environments: chemical reaction setup, LCMS analysis, SAR evaluation, split and pool library synthesis workflows, parallel reaction development, as well as from biology laboratories: aqueous buffer preparation, centrifuge use, ethanol precipitation of DNA, A260 DNA quantification, gel electrophoresis, bioanalyzer analysis, enzymatic DNA ligation. An exposure to some of these techniques is helpful in training into a DNA encoded scientist.

Technical activities include projects leading to product improvement.  You will also contribute on several levels including: Contribute documentation for support of project Design History Files. Gain cadaver lab/OR experience – support Surgeon training. Interface effectively with suppliers and become educated on manufacturing methods and capabilities. Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485

The Associate Distribution Coordinator initiates, maintains, and compiles records associated with ordering, receiving, storing, issuing, and shipping materials, supplies, and equipment by performing the following duties: Compares nomenclature, stock numbers, and other listed information on packing slips to verify the accuracy of purchase orders and shipping orders. Compiles data from sources such as contracts, purchase orders, invoices, requisitions, and accounting reports and writes, types, or enters information into computer to maintain inventory, purchasing, shipping, and other records. Compiles and maintains manual or computerized records such as material inventory, in-process production reports, and status of material locations

Technical activities include projects leading to product improvement.  You will also contribute on several levels including: Contribute documentation for support of project Design History Files. Gain cadaver lab/OR experience – support Surgeon training. Interface effectively with suppliers and become educated on manufacturing methods and capabilities. Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485

The Downstream Pilot Plant Technician I reports to Downstream Pilot Plant Manager and performs method development, product and process development, scale up/scale down processing and purification, performing a wide variety of activities including but not limited to the following: Basic cell and tissue culture of prokaryotic and eukaryotic systems. Expression and purification of recombinant proteins using a variety of expression systems. General analytical chemistry, protein biochemistry and molecular biology methods such as liquid chromatography (HPLC, FPLC and low pressure systems), gel electrophoresis, western blotting, ELISA, PCR, protein assays, enzyme/bioactivity assays and bioinformatics.

The Transducer Design Engineer performs engineering design, development, and maintenance tasks, and assist in various phases of ongoing projects. He / She works with a dynamic team of product managers, mechanical, acoustical and manufacturing engineers to improve existing and create new best-in-class single-element and phased array probes. The incumbent's work includes concept generation, CAD layouts, detail design, fixture design and testing.

The Associate Imaging Representative (confocal) functions as a resource for the customer. Identify customer needs based upon detailed discussions. Using product and application knowledge, provide solutions to meet their imaging and system needs. Install and train customer using equipment purchased.

The Regulatory Affairs Analyst I is responsible for the review and investigation of medical device complaints. The incumebent coordinates the resolution of complaints and ensures that timely investigations are performed. He/She prepares and files Medical Device Report (MDR) for Medical Systems Group (MSG) products. The RA Analyst I maintains quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas of responsibility. The incumbent functions as part of MSGs Regulatory Affairs team, in fulfillment of corporate objectives for FDA regulatory compliance. He/She requires general instruction for routine assignments, from Supervisor and/or more experienced staff.

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.

Manufacturing Technician I is responsible for completing and assisting with daily tasks associated with cell-related functions, including producing cells, intermediate product, and manufacturing final product for commercial distribution. Additionally, the Technician I will be responsible for following SOPs, performing daily tasks in a clean room/cGMP environment per the current QSRs. The Manufacturing Technician I may also be responsible for the troubleshooting of manufacturing challenges

The Manufacturing Technician I - TCS is responsible for completing and assisting with daily tasks associated with support related functions for TC including assembly and sterilization of sub-assembly items, material management and manufacturing final product for commercial distribution. Responsible for following SOPs, performing daily tasks in a clean room/cGMP environment per the current QSRs. May also be responsible for troubleshooting manufacturing product challenges. Follows established company rules, regulations and safety precautions, and maintains quality standards

The Production Associate I - Collagen performs activities involved in the production of Collagen  These activities include, but are not limited to, protein purifications, filtrations, and titrations in the production of high quality, purified, sterile collagen for both internal and external customers.  This position requires working in a regulated area under the direct supervision of a team leader or departmental supervisor. 

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. Strong organizational skills and possess strong ability to identify, analyze and solve the problems independently.

Working under the direction of senior marketing personnel, the individual will initiate, coordinate and / or execute a wide variety of marketing tasks to help drive adoption and education of the Global Spine product lines. Execute strategic and tactical plans to support market growth of the Global Spine products. Collaborate with the Events Planning team to coordinate and manage Global Spine trade show activities. Develop and maintain Global Spine engagement on social media channels such as LinkedIn, Facebook, Twitter and YouTube, and identify new opportunities where Global Spine should interact in the future.

The Validation Engineer is responsible for supporting validation activities pertaining to new and existing cGMP systems including process equipment, utilities, cleaning, and computer systems according to current Good Manufacturing Practices (cGMP). The validation activities will include but are not limited to measuring, analyzing, and calibrating equipment and processes to ensure all cGMP systems and equipment are operating according to the predefined specifications and the output of the systems or equipment are consistently and reliably meeting the needs of the user.

The Physical Properties Technician will perform routine testing/characterization on a drug delivery device in a GMP laboratory setting. Perform physical properties characterization on a medical device such as appearance, adhesion, and performance. Perform wet chemistry as needed and properly dispose of samples and reagents. Operate instrumentation such as FTIR, microscopes, and other dimensional analysis tools

Responsible for performing inspections and laboratory analysis utilizing a variety of techniques, to ensure quality of production. This includes quality checks of raw materials used in the production process to ensure they meet ISO standards; quality checks of production samples and final products prior to shipment to the customer. This includes transferring clear and accurate data from all laboratory analyses performed to the appropriate department.

Highly experienced in an analytical development and/or QC laboratory with a track record of successful development of PCR-based, ELISA-based, and/or flow cytometry-based methods for GMP and GLP use, including creating analytical development plans and experiment design, generation of test procedures, qualification/validation, and establishing product specifications and critical quality attributes and limits.

The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging. Quality activities include product sampling and inspection, area clearance to confirm process readiness, and non-conforming event support to resolve in-process issues. Communicates to multiple departments and supervision to provide timely process and issue updates

Learns to receive components and supplies, pulling orders, issuing and returning components, shipping product, assisting with inventory, and maintaining warehouse cleanliness.   Completes tasks with close supervision or oversight.  May participate in continuous improvement projects.  Interfaces with other departments.   

Primarily responsible for processing, analyzing, negotiating and collecting disputes related to quarterly Medicaid Rebates for approximately 2,000 products and 51 state entities for 8 Labeler codes for a total of 1, 227 quarterly invoices (shared with approximately 8 other analysts).

The Validation Engineer is responsible for qualifying cGMP manufacturing equipment cleaning, process validation, and aseptic/sterile processes. Generates qualification protocol(s), for various processes in the facility. Oversees the timely completion of all validation documentation, including coordination of contractor activities. Works closely with Manufacturing, QA/QC and Facilities staff in the execution of validation activities, as applicable.

The Associate Scientist/Engineer I/II is actively engaged in process and product development within a dynamic team and displays strong technical knowledge, initiative, and scientific commitment, and makes significant scientific and technical contributions to downstream process development. Integral team member in moving projects forward toward GMP Manufacturing for clinical trials, registration, improvements of existing processes and products

Establish and evaluate all PCBA manufacturing processes, including Surface Mount Technology and Wave Soldering. Established understanding of printed circuit assembly processes including: solder paste printing, placement, reflow profiling of thermal characteristics, automated inspection parameters, IPC 610 F acceptability requirements.

The R&D Scientist is responsible for the hands-on development of immunoassays, such as ELISAs and cell-based assays, for commercial production. This individual plans and executes design, development, and Manufacturing transfer of bioanalytical assays for product commercialization. The R&D Scientist is also responsible for development of custom assays and reagents for clients.

To ensure the quality of PBL reagents the Quality Control (QC) Scientist I will perform release and stability testing of interferons, antibodies, and manufactured ELISA kits. In addition, the QC Scientist I will perform bioassays or immunoassays to troubleshoot relevant customer issues and design and initiate experiments and projects to improve the quality of PBL products. The QC Scientist I may also serve as back up to the Product Development, Assay Services, or Manufacturing departments as needed: such additional duties may include designing and performing ELISA testing protocols, custom bioassays, and solution preparation. This individual will be involved with document control, SOP writing, and recordkeeping.

Design packages, processes, and tooling to package pharmaceutical products in a consistent high quality package which complies with cGMP's and customer requirements.

Support implementation of ERP system by perfoming data scrubbing and conversion efforts. Extract, map, and transform data to meet ERP migration requirements.

Working with Business Development Executives, provides high quality clinical packaging and distribution proposals within expected timeframe. Based on quote requirements, works with various internal departments to calculate complex costing in order to deliver Proposals and Change Orders to customer's right first time. Prepares and presents proposals to Business Development Executives and customers during customer facing meetings when applicable.

As a Quality Control Inspector, you will test and inspect components and products in the laboratory. Perform routine inspection at incoming Quality Control and finished device level. Inspect components, products, labels, boxes, pouches, and coatings visually and mechanically. Take measurements using micrometers, calipers, snap gages, gage pins and other measuring instruments.

Maintain the accuracy and control of material receipts, raw material and finished goods inventory locations. Maintain accurate logs and files for receipts, lot control, and daily shipments. Process domestic and international shipments consisting of pulling the order, entering data into the computer system and scheduling carrier pick up. Update and maintain cycle counting on a routine basis with other staff members.

The Level 1 Validation Engineer/Specialist works within a small team environment to provide technical services to pharmaceutical or medical device manufacturers.  Technical services may include interpreting drawings, manuals, or other technical information to develop requirement documents, developing testing documents that verify installation, and/or operation of the equipment, and execution /documentation of these testing documents.

The candidate will conduct laboratory maintenance procedures in compliance with established protocols and in compliance with regulatory and laboratory requirements. Maintains suite equipment including, but not limited to: incubators, water baths, and biosafety cabinets. Monitors incubator temperature, CO2 and humidity. Responsible for the cleaning, sterilization and equipment functionality.

Perrigo Nutritionals, in Georgia, VT is looking to add Process Operators to their team. The shift for this position is 6:00 pm–6:06 am requiring shift, weekend, and holiday work (when applicable). Operating and understanding of all processing equipment (HTST/UHT, Homogenizer, clarifier, etc.) and Wet Process Control Systems (WPCS). Operating and understanding of all liquefying equipment (dry and wet) and process controls. Performs general housekeeping and cleans processing equipment and areas.

Perrigo is looking to add an Associate SAP Developer to its team located at their North American HQ in Allegan, MI.  The Associate Developer will be accountable for designing, developing, testing, and implementing SAP-based applications written primarily in ABAP.  The Associate Developer will also provide day-to-day applications support of SAP and other integrated systems, including quick and efficient problem analyses and resolution.

An Associate Scientist (R1) position is available in the Process Development group of Bioprocess R&D.  The successful applicant will join a team of scientists and engineers focused on developing and optimizing microbial/ mammalian cell culture processes for recombinant proteins and biologics for early- and late-phase clinical trials.  In this role you will be responsible for designing and executing bioreactor experiments in bench-top bioreactors and associated scale-down equipment with the goal of developing robust, scalable, and high productivity processes that produce therapeutic proteins with the appropriate product quality to treat human disease. 

Provide engineering and technical support related to the operation, maintenance, installation, startup/commissioning, testing, and qualification of process and automated equipment and systems within a biopharmaceutical manufacturing facility.  This may include production equipment such as bioreactors, fermentors, ultrafiltration skids, Clean – In – Place (CIP) skids, and other support equipment.

This role is a hands on statistical programmer supporting study and asset teams in the delivery of less complex statistical programming deliverables. Ensures excellence in the programming of analysis ready datasets, tables, listings, and figures, and qc work for which they are responsible. Ensures adherence to high quality programming standards in their daily work. Accountable for their assigned work in the programming space supporting the programming leads for a particular study or asset deliverable.

In this role, you have the opportunity to manage the manufacturing of Philips AED products.  Within this role, you will have end-to-end responsibility for a production line, which included part delivery, manufacturing and test flows and packaging.  You will implement and validate the changes required to meet maintain compliance with Internal documents and regulated industry requirements.

Physical Sciences Inc., located just north of Boston in Andover, is looking for a chemical scientist to conduct research, development, test and evaluation (RDT&E) of innovative energetic materials for propulsion and munitions systems. Emphasis is placed on laboratory scale and pilot scale processing of ingredients and formulations for fuels, oxidizers, propellants, and explosive compositions. We are seeking an individual with a strong background in wet chemistry and analytical instrumentation to join a multi-disciplinary team of engineers and scientists. This individual will play a key role in growing a diverse portfolio of technologies funded by the DoD and NASA. etc.

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.

Reporting to the Supervisor of Engineering, the Facilities Technician will be responsible for PMI’s maintenance and equipment support activities. The Facilities Technician performs with minimal supervision preventive maintenance, demand maintenance and calibration tasks on critical equipment, utilities, and facilities.  

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.

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.

Provides line-level management coordination of resources and work schedules for laboratory activities. Oversees daily operations and assists in preparation and implementation of company policies, quality systems and training programs. Ensures that projects are completed in a timely manner so that company revenues are met and clients are satisfied with the quality and turnaround time of work being performed.

The basic purpose of the Quality Assurance (QA) Auditor is to assure the quality of laboratory data and reports.  This is accomplished by reviewing data and reports as specified by SOP's (Standard Operating Procedures), and by conducting project specific audits of laboratory procedures and by writing audit 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. \

As a clinical trial associate, you will assist the Clinical Project Managers in the conduct of trials and may be responsible for managing start up activities, vendor communication, or other project activities as assigned.

Under specific direction, the Research Assistant, In Vivo Models will assist and perform a variety of routine technical procedures related to the execution of animal studies including: animal identification, colony management, injection of cells and new constructs, imaging, monitoring animal behavior, collecting specimens and euthanasia. May perform tasks related to the research project independently, but within specific guidelines. Strong communication skills and comfort in interdisciplinary lab required. Some evening and weekend work required. etc.

The Associate Process Engineer works within the Cell Therapy Development team and will participate in process development efforts, delivering best-in-class manufacturing methods for allogeneic T cell therapies. The position will assist in the clinical progression of candidate CAR and TCR T cell therapies by designing and executing process development experiments across a variety of process scales. The Associate Process Engineer will collaborate internally across functional areas as well as externally with industry partners to ensure project advancement, rapid and best-in-class execution, and effective communication of challenges and opportunities.

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 Proposal Associate works closely with a cross-functional team to provide responses to laboratory services RFPs and RFIs from government and commercial clients. You will support the proposal process from receipt of RFP through submission and pipeline tracking. Typical duties include attending proposal development meetings, tracking proposal statuses, assisting with developing pricing and text for proposals and quotes, crafting and distributing reports, and tracking opportunities in Salesforce.com.

Authoring and reviewing statistical analysis plans, including development of table and listing shells. Providing input into development of case report forms (CRFs). Generating randomization schedules and providing sample size calculations. Generating analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS.

We are looking for a full-time Vivarium Assistant to perform husbandry tasks such as thechanging and cleaning of animal cages, feeding/watering of animals, and the sanitation/ cleaning of the animal facility.

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.

This position is responsible for performing pharmaceutical related functions in compliance with state and federal regulations, protocol specific requirements, and the Company’s values, policies, and procedures under the direction of the Pharmaceutical Services Supervisor. Receive, label, store, organize, and return/destroy study medications for clinical trials. Prepare and update all drug inventory logs and ensure logs are current with all clinical trial drug preparation schedules.

Experience across multiple therapeutic areas e.g. gastrointestinal, hematology preferred. Experience and understanding of study start-up processes, including Trial Master File and associated document management procedures. Good overall understanding of the major areas within clinical operations. Excellent communication and interpersonal skills, along with attention to detail and organizational skills. Strong written and spoken English. Ability to collaborate, problem solve and work in a small dynamic company with minimal supervision, to achieve personal and team goals.

The Research Associate will be an integral member developing new technologies for protein analysis. This will position will report in to the R&D Science group and support product development (Consumables/Reagents and Instruments) from conceptualization to commercialization. Key responsibilities include: Assist product development by performing experiments and in-depth data analysis. Design and execute experimental plans independently. Observe and meticulously record all details during product development

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.