Links to 770 Entry-Level Biotechnology & Life Science Jobs

Individual responsibilities include purifying and testing antibodies/T cell receptors via FPLC/His-tag purification/ELISA/flow cytometry, generating DNA libraries via PCR, and interfacing between teams of computation and experimental biologists.

As a member of the quality engineering team, you will conduct product complaint investigations by reviewing reports filled worldwide, coordinating product testing with other departments, and communication internally and externally regarding aformentioned complaints. Oppertunity to also expand into development of quality engineering methodologies and quality engineering support.

Key responsibilities for the Laboratory Technician are: Executing standard operating procedures for the supportof company products;maintaining documentation of signatures, dates,labels etc.,relating to laboratory supplies and operation of laboratory equipment

Associate Scientist must be able to preform assays determining cytokine/chemokine levels, gene expression analysis, cell culture experiments, molecular biology techniques, and a willingness to work with rodent models. Candidate prefered to have experience in cell culture, and DNA/RNA sample prep.

Core responsibilities of a Research Associate will be to provide support to the immunoassay development team through the use of antibody-based laboratory techniques such as sandwich ELISA, Western blot, immunocytochemistry, and flow cytometry as well as the generation of biological materials for analysis. Data must be well documented and communicated efficiently in technical notes and reports.

The core responsibilities of a Quality Control Associate will be to provide support to the quality control team by testing our catalog of products after they have completed the manufacturing process. These products include sandwich ELISA kits, Western blot antibodies and cocktails, immunocytochemistry antibodies, and flow cytometry kits.

Under the direction of the Molecular Science team, the Research Associate will support experimental research in AbSci's 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 Mechanical Design Engineer is responsible for researching, planning, designing and developing the mechanical and structural portions of the company’s products in accordance with requriments established from various sources including marketing, manufactoring, reliability, etc. This individual will also direct and coordinate activities involved in process selection for the fabrication, assembly and testing of mechanical designs in accordance with product requirements.

As a Manufacturing Associate, you will perform performs routine and complex operations for the GMP production of pharmaceutical products. Responsibilities include the operation and monitoring of equipment for production of clinical/commercial pharmaceutical products, execution of production activities such as spray drying and capsule filling, and troubleshooting of manufacturing equipment. Experience with automated manufacturing control systems preferred.

A Sales Associate will market Acumed products to key surgeons using high level technical and surgical understanding of products and needs. Individual will focus on developing relations, responding to customer needs, technical advice, and product solutions. Ability to continuously assess consumer base to identify new business opportunities key.

As a QC Lab Support Associate, you will perform lab support duties such as glassware washing, maintance of supplies, assistance with sample handling, utilization of cGMP/cGDP ractices in documentation of job functions, and ensures assigned areas meet all regulatory requirements.

e seek highly motivated candidate with experience in mammalian cell culture, gene expression analysis and cell-based assay development. The successful individual will play an integral role in a small team of scientists working on RNAi technology development. You will be expected to perform under minimal supervision and be capable of having a steep learning curve in a fast-paced startup environment.

This is a Development Associate I position in the Upstream Process Development group. Primary responsibility will be to support mammalian cell culture processes used for the manufacture of therapeutic recombinant proteins. The successful candidate will be responsible for supporting shake flask and bioreactor experiments, sampling, inoculating, feeding & harvesting bioreactors. Under general supervision, this person carries out routine to moderately complex experiments or procedures.

As an Engineer in Upstrea, Process Development, you will plan, execute, and troubleshoot experiments for the optimization of upstream process steps in flasks and bioreactors for approved research plans, optimizing process parameteres to increase virus yield from adherent & suspension cell lines, and collect and analyze data in the course of biologics production and processing.

As a Microbiologist, you will perform routine microbiological testing of products, raw materials, components and controled environments according to SOPs. Additional responsibilities include documentation, and assisting in non-conformance investigations, and the issuing of GMP documents.

Seeking a Research Scientist to develop and perform cellular and molecular biology experiments in order to identify molecules and their functions in diverse matrices, including mouse, monkey, and human tumor and organs (tissue dissociation) and serum samples. To develope assays to characterize protease activity, and use various immunofluorescent tehniques on tumor/histological slides.

The Quality Engineer is responsible for working with the Quality and Manufacturing teams to support activities during the overall product life cycle of the assigned production area(s). The QE will support improvement projects, quality issue resolution, Non-conformances/CAPAs, process control, product transfers and validations. In some cases, the QE will be required to lead small to medium size projects. Responsibilities include data collection and analysis, implementation and revision of product conformance standards, continuous process improvement, reduction of reject levels and assigned projects and change control tasks, etc. Ensure there are adequate product and process controls in place for identified critical or major quality attributes/process parameters within assigned production area(s). Complete gap analysis against local, global, and industry standards, as needed, and support development/execution of actions to close gaps under minimal guidance.

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. Responsibilities include design, planning, and performing rodent in vivo studies.

The Regulatory Assistant works with the regulatory team coordinating activities regarding submission of documents to FDA and other governing bodies. Other responsibilities may include team progress tracking and project management. Responsibilities include compling and reviewing regulatory submissions, formatting/proofreading documents, tracking ongoing projects, and participate in quality assurance processes.

The Programmer Analyst I is a computer programming position responsible for delivering technical services relating to clinical trials data. This includes working with Electronic Data Capture (EDC) and other data management applications to achieve project integrity and the delivery of on-time, quality data. The Programmer Analyst I analyzes the feasibility of program requirements to develop applications that meet FDA guidelines.

As a Lab Associate I, you will provide general support for our laboratory by assisting in sample processing, preparation of reagents, equipment maintenance, etc. for our staff scientists/histotechs. This position is a great entry-level position for individuals looking to start their careers in a clinical laboratory setting. Perform biological specimen patient preparation, labeling, handling, and transportation and storage of specimens. Follow all procedures and protocols pertaining to patient sample processing, pre-analytical, analytical, and post-analytical testing and general laboratory system. Maintain laboratory safety by ensuring work area is safe and clean, noting any problems that may require prompt and proper repair

This R&D position will be responsible for testing of raw materials, finished products, and stability samples using existing analytical methods and wet chemistry. Perform routine analytical testing of raw materials, finished product, stability samples and lab batch samples. Record and report all lab data as per approved procedures and regulatory requirements.

The Associate Technical Engineering role will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. Will also ensure that supported areas and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards in the Inspection and Packaging area in Non Standard Shifts structure. Responsibilities include but are not limited to: Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards, Participate in the coordination of TECHSUPPORT on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues, and Execute advanced maintenance activities, or operate and monitor complex plant support equipment, with ability to investigate complex issues or problems with guidance from more experienced personnel.

This position will be responsible for the transfection or transduction of gene therapy-related constructs for the characterization of protein expression efficiency and protein product characteristics across a wide range of therapeutic targets. Duties include maintenance of appropriate cell systems for evaluation of protein expression, transfection/transudction of transgene constructs, protein expression measurements, documentation, and data analysis/presentation.

This position will be responsible for the characterization of enzymes expressed in tissues as well as mammalian and prokaryotic cell systems.This resource will apply a knowledge of protein quantitation and analysis techniques both in vitro and in cell-based models to characterize protein products including plate-based assays, SDS-PAGE, and Western blotting

The Scientist 1 - QC is an entry-level role responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, to clearly document activities performed during testing and to calculate and report results on applicable specification documents. Performs physical and chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques adhering to company policies as identified in standard operating procedures (SOPs).

This position is in the R&D department and is responsible for production support and process development of pharmaceutical ingredients: Develops scalable manufacturing processes in an cGMP environment. Conducts experiments to optimize processes for commercial manufacture. Meets with groups internally and externally for project meetings and prepares data for presentations. Effectively participates in Process R&D team meetings.

The Package Testing Technician is an integral part of the AMRI team, contributing to our success by performing data review, auditing laboratories, investigation/corrective action follow-up, and reviewing written procedures. Responsibilities include: Independently perform duties, both routine and non-routine, completed in a reliable and accurate manner. Endure the integrity of the final report of analysis being in compliance with all regulatory and company standards. Primary QA reviewer of all analytical data generated in the laboratory and performs weekly review of all logbooks, temperature tracking documents and any other related logs maintained in the laboratory.

The Research Scientist I is an integral part of the AMRI team, contributing to our success by performing laboratory experiments and instrumental testing in the Analytical Development group. Responsibilities include: Conduct laboratory experiments as part of development and validation of solid-state chemistry analytical methods to support drug development processes, including but not limited to preparation of solid-state mixtures and studies of solid-state attributes of materials. Perform routine instrumental testing according to study design and under the guidance of the project leader.

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. Some responsibilities include: Perform microbiological testing (endotoxin, sterility and bioburden) for raw materials, in-process materials, intermediates and final product. Perform environmental monitoring of the clean rooms (under ISO and EU specifications). Read, trend and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results.

The Research Scientist I is an integral part of the AMRI team, contributing to our success by developing and optimizing processes for the production of Active Pharmaceutical Ingredients (APIs). In this role, you will: Synthesize known compounds efficiently using literature or in-house notebook procedures. Purify reaction mixtures by chromatographic, crystallization, and distillation techniques as appropriate. Analyze reactions and compounds using a range of modern separation and spectroscopic techniques including TLC, HPLC, IR, and NMR. Conduct literature searches for specific target compounds, structures related to the target compound, or to determine specific conditions for compounds and reactions. Optimize the reaction processes for scale-up by making appropriate modifications of known methods or modification of reaction conditions under the supervision of a senior chemist.

The Research Scientist I, Analytical is an integral part of the AMRI team, contributing to our success by providing timely high-quality analytical support for our client.

We are looking for a Document Control Specialist to assist in the management of the QMS document control process, writing SOPs, review and archiving records. Duties include writing and reviewing SOPs, tracking document flow, archiving manufacturing and quality records, and ensure aduiting and manufacturing documentation is up to date.

The Regulatory Affairs Associate, with some guidance prepares, reviews and submits high quality, regulatory submissions such as ANDAs to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Duties will include: Coordinates with external vendors for project support activities. This may include but not limited to RS statements, TSE/BSE statements, Melamine free certificates, cGMP certificates, Debarment certificates, US agent letters, DMF LoAs, Technical data sheets, and technical drawings, Quantitative compositions of colors, flavors e.t.c., Organize and maintain submission components associated with a regulatory submission electronically. This may include scanning, converting to pdf, bookmarking, hyper linking, electronic processing and uploading in e-CTD Xpress e.t.c under superior guidance.

In this role, you will be responsible for leading and carrying out required lab activities for RNA targets and assist with the cloning and production of plasmid constructs. Duties include the development of biochemical assays, to produce/purify RNA, prepare SOPs, and support project leads, internal/external stakeholders, and research leadership as needed.

Array’s medicinal chemistry group has openings for motivated synthetic organic chemists who are able to work in a team environment to deliver quality drug candidates with a sense of urgency. Primary responsibilities are to demonstrates technical competency in reaction set-up, product isolation, purification and analysis, from milligram to multigram scale.

This is a rotational program for the Global QA and RA departments.  The scope of the rotation is limited to Florida, to include Arthrex INC, AMI, and ALC.  The associate is responsible for supporting the QA/RA Departments with quality related support for improving and maintaining the Arthrex global Quality Management System (QMS) to ensure compliance to FDA QSR, ISO 13485, and all other applicable regulatory requirements.  This is to be accomplished developmentally by working in various sectors of QA/RA, to include Product Surveillance, Quality Systems and Regulatory Compliance, Pre-Production Quality, Supplier Quality, Regulatory Affairs, and Manufacturing Quality Engineering.

Asuragen is seeking an outstanding scientist to work as part of a product development team to develop, launch and maintain molecular diagnostic products for inherited genetic disease and cancer testing. The successful candidate will contribute to new product initiatives through requirements definition, prototype design, optimization, verification, validation and troubleshooting of assays under FDA and ISO Design Control regulations. A significant focus will be on process and specification development across multiple PCR-based assay formats and technologies, including NGS, PCR/CE and qPCR.

Auris is looking for a Mechanical Engineer who will support the design and development of robotic systems for medical applications. This Mechanical Engineer will work closely with engineers from other teams to design and develop robotic equipment that meets clinical, user, and safety requirements. Responsibilities include: design/create electromechanical prototypes, provides hands-on troubleshooting, process and manufacturing support as well as designing implementing, integrating and testing hardware solutions, create design solutions, utilizing engineering methods, etc.

We are seeking a Research Associate/Sr. Associate, Process Development who is interested in pursuing a career in developing biologics and pharmaceutical agents. The Research Associate/Sr. ("RA") will assist process development in developing and optimizing scalable processes with improved product yield and reduced costs for manufacturing systems. In addition, the Sr. RA may assist with the maintenance of production equipment and may research and implement new methods and technologies to enhance process operations.

Position as Associate Engineer will provide support toward the design, development, installation, startup, validation, quality and maintenance of products, processes, and equipment. Responsibilities includes research, develop, and prepare specifications for improvements to existing and/or new products, processes, equipment, and technology. Must be able to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations, to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry, to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. and 

This position is intended to perform Quality Control Testing to support acceptance of raw materials and finished product. This position will cross-train to perform all laboratory tests to support dialyzer manufacturing. These tests will include microbiological, chemical, and performance tests. Performs required tests in the performance, microbiological, and chemical labs on finished dialyzers and raw materials to support product acceptance. This includes performing analyses, calibrations and maintenance on multiple lab equipment/instruments and entering results in the Guardus system. May assist with environmental and process media monitoring by taking samples and testing as required by defined procedure. Maintains cleanliness of labs and lab instruments

This position will assist with complaint investigations, quality management remediation efforts and other quality engineering activities as required. Assist with Monthly Reporting Related to Post Market Surveillance. Assist with Engineering representation on Product Development Teams. Develop physical and functional test methods to ensure specifications are met. Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications. Perform process improvement, control and monitoring on manufacturing processes.

This position is responsible for supporting the manufacturing operation. This individual will develop and implement improved methods of manufacturing, procedures and processes that result in improved efficiencies; yields, machine operations, and quality. Provides technical support to the development group for the implementation of new products or processes.

As a Research Associate, you will assist in production of insect-derived RUO and GMP recombinant proteins in various bioreactor systems as well as various human cell lines for CAP Survey, media and supplement preparation, and all other duties as assigned. In this position, your scheduled work-week is Tuesday through Saturday.

Bio-Techne’s Protein Platform Division is looking for a Manufacturing Technician with a motivation to participate in the growth of a fast-paced company engaged in cutting edge biological research. The successful candidate will work with other members of the Reagent production team to make great products, performing tasks involving plate filling, labeling, vialing, and finishing materials. Operation of semi-automated liquid dispensing equipment is integral to the job. Qualifications Requirements · 1+ years of working in a relevant manufacturing environment. · Familiar with basic calculations and units of measure · Experience with peristaltic pumps, pipettes and balances · Good communication skills (verbal and written English) · Able to pick up heavy items (5-50lbs) · Flexible schedule to work different shifts. Desired skills · Strong attention to detail · Ability to work in a high-growth environment · Document pertinent information consistently and accurately · Maintain a clean and organized work-space · Maintains a positive attitude on a daily basis · Work well in collaborative settings and on an individual basis · Experience in an ISO or GMP biotech environment is a plus

The Product Engineer will be a part of the process development team, supporting optimizing production conditions and characterization of hydrogel particles for research use. Candidate will be expected to prepare/characterize hydrogel microparticles, and to develop new formulations and processing conditions to meet functional requirements.

We are currently looking for an enthusiastic scientist to join our manufacturing team. This position will entail preparing reagents for our assay kits, QCing and packaging the finished products. This candidate may also join part time in our R&D team.

Work as part of Lab Services team to provide support for all routine Histology and IHC work pertaining to delivery of CAP/CLIA and GLP-like oriented lab services offered to external partners, including BioPharma, Academia, and Oncology Research Centers.

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 position also works closely with the Development and Operations management team, the Laboratory Directors, as well as cross-functional team members in Customer Service, Quality and other departments as needed. Ongoing training will be provided to supplement key skills required to perform the functions of this position as applicable.

As a member of Biogen’s Drug Product development team, the candidate will be responsible for providing formulation and process development support for injectable protein drug product development programs. Planning, executing, and communicating results from laboratory studies is a requirement of the position. Laboratory support of department innovation initiatives is also an expectation of the position.

This position will focus on development of high productivity and robust cell culture processes through classically and statistically designed experiments. The candidate’s goals will be to increase process robustness and productivity through comprehensive understanding of levers important to mammalian cell culture. A major component of the role will involve conducting and documenting laboratory bioreactor experiments with a focus on process definition and understanding, experimental design and troubleshooting, and data analysis. The ideal candidate will be able to work collaboratively with pilot scale and tech transfer teams for execution of development projects. In addition, the ideal candidate will contribute to improving laboratory process workflows, making laboratory work more efficient and with greater impact. The right candidate may also contribute to novel laboratory technology or continuous improvement projects. Candidates must be strong team players and have an ability to collaborate effectively on complex projects. A strong affinity for the laboratory with demonstrated success using those techniques is expected.

Performs PM revisions, & other CMMS inventory management tasks. The incumbent maintains knowledge of planned preventive maintenance techniques and procedures; maintains good working knowledge of mechanical equipment to provide support to Maintenance, Manufacturing, I&C and Engineering staffs, and functions as the primary contact for all inventory related issues for MRO purchases and stock.

he employee will perform surface, intracellular, and multicolor testing and analysis, and will assist with preparation of primary cells and culture of various cell lines, as well as the set-up of cell stimulations needed for testing. Primary responsibilities include performing experiments (e.g. cell culture, cell preparation and flow cytometry testing); production and analysis of reliable, reportable data; maintaining accurate documentation; utilization of internal company databases for product filing and retrieval; following company SOPs and ISO requirements.

BioLegend is seeking a highly motivated Research Associate to join our fast-growing, dynamic and collaborative Product Development team in San Diego. This position will actively participate in all stages of the development, optimization and validation of new products, including antibodies, proteins, and other probes for various research fields. The primary responsibilities include performing experiments (e.g. cell culture and flow cytometry), analyzing and reporting data, maintaining accurate documentations, etc.

As part of the Process Development team, this position will support optimizing production condition and characterization of CloudzTM hydrogel particles for research and clinical use. The role will focus on formulating new hydrogel formulations and identifying optimal particle formation conditions to deliver scalable, repeatable and functional product for a variety of internal and external customer projects. Additionally, the Product Engineer will contribute to developing new chemical, imaging and physical particle analysis tools with opportunity to collaborate with technical groups across Bio-Techne.

The individual in this position will work in a team environment. Their primary responsibilities include supporting feasibility studies and product development of Hematology controls. They assist with the optimization and testing of components, develop manufacturing procedures, and perform necessary troubleshooting. The individual is trained and follows standard practices and procedures to ensure a safe working environment.

You will have responsibilities for executing all process steps in the manufacture of lentiviral vector (LVV), a critical starting material in our gene therapy platform. This role will focus on both the facility startup, new product technology transfers and routine (clinical and commercial) manufacturing. As part of new facility design, construction, startup, and transition to routine operations, this individual will work with the cross-functional bluebird team, including Quality Assurance, Quality Control, Facilities, Manufacturing Sciences & Technology, and Process Development to lead day-to-day operations. We seek candidates with proven ability to work in a GMP environment. Specifically, we are looking for team members with track records of building a safety culture, driving the highest standards of a quality mindset, and ensuring uninterrupted supply for patients.

Performs bio-analytical methods (immunological, in vivo, microbiological, molecular biological, or virological) for various Bio QC tests on raw materials, in-process, release or stability samples in compliance with 9CFR, EU and VICH regulatory guidelines, Outlines of Production and Special Outlines. Initiates, executes and completes assays as per validated procedures and within Quality and Compliance guidelines and communicates testing, compliance and/or scheduling issues to supervisors.

The Quality Assurance Compliance Associate performs activities in support of dispositioning product and/or raw materials while ensuring clarity and compliance Brammer Bio policies and procedures, customer requirements, and regulatory standards. Responsibilities include but not limited to: Review and approval of all documentation related to late phase and commercial manufacturing to ensure timely review and disposition of client batches/lots. Review and approval includes manufacturing batch record reviews, internal records, client records, and master batch records. Support conditional and final GMP release activities for disposition of bulk drug substance and drug product.

The Laboratory Technician will work in the QC cGMP compliant Laboratories to develop, qualify, and conduct cell-based, nucleic acid-based, protein-based, and chemistry-based assays that support quality control of biopharmaceutical products being developed and manufactured at Brammer Bio under contract. Duties include performing routine assays and testing including but not limited to PCR, quantitative PCR, agarose gel electrophoresis, SDS-PAGE, immuno blotting, ELISAs, immunocytochemistry, and infectivity and reporter gene based cell assays using insect or mammalian cell lines. The Laboratory Technician will also troubleshoot and optimize assays under the supervision of the GMP QC Manager/ Research Coordinator. Functions also involve maintenance of cell lines used in the QC laboratories, maintenance (routine and preventive operation) of equipment, and preparation and purification of commonly used biological reagent and chemical supplies. The Laboratory Technician will be expected to technically interpret and review data produced from the assays they run.

To perform QC analytical testing in support of biologics bulk drug substance manufacturing using defined methods in a cGMP compliant laboratory. Assures test results are accurately recorded and abnormal data or equipment/instrument malfunctions are promptly reported to his/her supervisor

The Associate Research Scientist will join the Mechanistic Disease Discovery Research team at Bristol-Myers Squibb in Redwood City, CA and aide in the advancement of early stage therapeutic targets. This position will support day-to-day operation of a next generation sequencing lab. Experience in sequencing of primary human samples, both tumor and immune-derived, as well as mouse samples will be key to successfully fulfilling the requirements. The position will require the individual to be highly collaborative and work closely with and support an array of project teams and scientists within the Discovery Research organization.

Perform routine environmental monitoring and clean utilities sampling and testing in accordance with SOPs, safety, and cGMP guidelines to support qualification of new facility. Monitor critical operating parameters for equipment and instrumentation to ensure standard operation. Recognize, report, and document deviations from test methodologies, specifications, and alert limits Develops working knowledge of cGMP, learn specific job related SOPs and develop proficiency in laboratory techniques.

C3J Therapeutics is seeking a Research Associate I/II to work with the R&D team. The candidate will support the overall program goals and strategy of the group which include significant laboratory activities, such as phage engineering and characterization, protein expression and preclinical evaluation of phage therapy efficacy in relevant animal models. The candidate will have broad molecular and cell biology experience. Previous experience with virology and viral vector construction (phage or mammalian viruses) will be considered a plus. Excellent verbal, presentation, and written communication skills are essential and the capability to effectively work in a team environment is required

Caribou is seeking an experienced Research Associate to join its R&D team at its facility in South San Francisco, CA.  The candidate must be motivated, enthusiastic, professional and committed to working as a team player.  The ideal candidate enlists confidence, comfort and a working knowledge of laboratory animals, with a background in animal husbandry, restraint and handling.  In addition, experience with injection and blood draw techniques, along with rodent surgery and anesthesia experience is desirable.  The candidate must have the ability to effectively communicate with coworkers, take direction from supervisors, and be accountable for their actions.  They must possess a strong attention to detail and always strive to perform quality work.  This is an excellent opportunity to utilize and advance the ideal candidate’s laboratory animal skills in a progressive, state-of-the-art and diverse facility.

We are seeking a highly motivated, Research Associate to participate in drug discovery programs that lead to the identification of new targets and drug candidates for clinical development.  The individual should possess strong core competencies in cell biology, molecular biology, assay development.

The Associate Scientist, Analytical Development is responsible for developing new analytical methods independently and transferring the methods internally or from/to clients. Duties include:  Executes all activities related to the analysis of proteins from mammalian cell culture ranging from SDS-PAGE analysis, ELISA analysis, various HPLC based methods, cIEF and product binding assays. The position requires strong documentation skills and the ability to follow SOPs. Independently develops/optimizes analytical methods to characterize protein/antibody, including, but not limited, to RP-HPLC, SEC, cIEF, and CE                                    

The Documentation Associate will support the creation, review, and processing of general documents and batch records.  The Documentation Associate is also responsible for issuing, distributing, and reviewing documents in a timely and efficient manner. Responsibilities include: Creating and updating master documents, issuing a copy of the current approved master documents for packaging or manufacturing; Compiling, summarizing and reporting information from the batch records as required; Accurately controlling the electronic and paper versions of all documents such as Standard Operating Procedures, Master Forms, Packaging Instructions and Production Batch Records;

Works with the project manager coordinating all aspects of communication and activities related to a project.  Prepares for, attends, and does follow-up for sponsor meetings; compiles documents for submission to the regulatory agencies or to the sponsor; coordinates the document review process; works with the clinical trial manager on the conduct of a clinical trial; creates and monitors project budgets; manages the project files; prepares project activity tracking reports and attends project review.

As part of the Product Sciences group, the energetic and motivated scientist will design, perform and interpret complex experiments related to the development of novel analytical tools and characterization of the final product and process intermediates for CAR-T products. This role will support the activities related to the identification of product critical quality attributes, in collaboration with Process/Analytical Development, Translational Development, Clinical and Immuno-Oncology research functions.

We are seeking an entry-level Research Associate to join our fast-paced, highly collaborative team.  The Research Associate will work as part of the Antibody Manufacturing Core to produce and purify antibodies for development. The Antibody Manufacturing Core is responsible for upstream processes to produce monoclonal antibodies in cell culture.

Duties and responsibilities include: preparing passaged and primary cells for use by in vivo and in vitro technicians as directed, performing related general duties such as inventorying supplies and reagents, general lab housekeeping, and maintaining safety records. Individual must be able to work effectively and productively in a team-oriented environment while maintaining a strong sense of accountability, integrity and confidentiality.

Primary objectives include supporting in vivo oncology studies in mice as a member of the Study Services Team. Individual should have experience conducting preclinical in vivo experintation in mice .

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

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

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

The Laboratory Specimen Assistant is responsible for managing specimen containers, data, and communications for accurate and timely tracking and disposition of specimens within the necropsy, trimming, and histology laboratories. Individuals in this role use effective communication and interpersonal skills in a collaborative team environment.

The responsibilities of this role as Technician I Microbiology will be specific to the Environmental Monitoring division of the Microbiology department. Daily activities and responsibilities of this role will include, but are not limited to the following:

This person will perform technical tasks in the conduct of in vivo research studies or support services in accordance with good animal welfare practices. Prepare, collect and record research data and specimens in compliance with applicable regulations and SOPs.

Generate 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.

Perform daily laboratory tasks and interpret data related to cell culture and media preparation.

The Sales Professional will lead a device territory base business and growth by promoting, selling, and supporting a Circassia Respiratory device product specifically across the Respiratory Specialty and Institutional space. This person will be tasked with successfully partnering cross-functionally with internal business partners in order to drive growth with current customers/accounts as well as develop new business with customers/accounts of high potential within the outlined geography.

The Clinical Trial Associate will support and work closely with the global project team including internal and external customers and suppliers through all phases of the study.  Duties may include coordination, participation in study meetings, minute taking or ADI Log maintenance, study and site binder creation, data entry, tracking, scanning, copying, creating, maintaining and QC of essential documents and Trial Master Files.  Coordinates and distributes study supplies.  Meets defined chargeability expectations for position.

The primary purpose of the QC Analytical Chemist is to provide support to the Production and Formulations Departments by analyzing pharmaceutical and/or cleaning samples.  Support will be provided by analyzing samples using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendial monographs, client procedures, and miscellaneous protocols.  The QC Analytical Chemist is expected to understand basic internal procedures, and conduct analyses with some supervision after training is complete.

This position will provide key engineering and validation support and project coordination primarily to the manufacturing process side of plant operations. Additionally, technical support for process and product investigations will be offered. Major responsibilities include: Provide technical support for the manufacturing processes, including process investigations, process changes, and technical transfer and scale up of new product introductions. Coordinate and execute tech transfer projects in support of new clinical and commercial products and contract manufacturing opportunities. In addition to project management responsibilities described above, individual will be required to interface with external clients and contractors in support of contract manufacturing opportunities. ect.

This is an opportunity to discover therapeutic antibodies for immuno-oncology applications. In this role, the successful candidate will participate in projects to select therapeutic leads by screening and characterizing antibodies from initial discovery using various assays and antibody production. This is a critical role that enables therapeutic lead selection and requires strong organization, attention to detail, generation of experimental data, troubleshooting skills, and presentation of work to project teams.

The Process Development Group provides support through the development and optimization of production processes. We work with our R&D and manufacturing colleagues. We are seeking a Research Associate to join our Fermentation Process Development team. This individual will collaborate with Scientists and Process Engineers to design experiments, record and analyze results, and participate in scale-up/scale-down activities. Responsibilities include performing media, buffer, and stock solution preparation, small scale studies, operating and monitoring fermentation processes, and routine sampling processing.

The Product Quality Engineer will be responsible for product quality engineering/ quality assurance activities. This includes interpretation and implementation of quality standards to routine manufacturing, continuous improvement, and product release activities. Essential duties include developing/maintaining working relationships across the company, performing quality testing of CER/water system, administer bioburden/endotoxin testing, implement/maintaining quality system in accordance to regulatory requirments, developing/upgrading procedures for quality system, etc.

 This engineer will have immediate opportunities to contribute to ongoing sustaining, and new product packaging initiatives working alongside other experienced Packaging Engineers, as well as cross-functionally with manufacturing, project management, R&D, procurement, regulatory, marketing, quality and operations team members. Duties include designing/implementing packaging designs and operation processes for mechanical function, manufacturability, and efficiency, perform in-process packing systems engineering tasks, prepare equipment validations protocols and reports, etc.

Work closely with project management and clients to establish required specifications for manufacturing materials from approved vendors and ensure sourced materials are available when required. Ensure materials are sampled by Quality Control and tested per the approved specifications. Work closely with the Quality Unit to ensure results for material testing are completed and submitted for approval in order to release for use in manufacturing. Support projects by locating sources and completing purchase orders as per the established internal processes and procedures.. Assist Purchasing with vendor management; factoring in costs, customer service, availability of materials and assessing reliability

Purpose of the position is to lead and/or participate on project teams to develop new manufacturing technology for the purposes of reducing cost, increasing capacity and/or improving product. Provide engineering-level production support to manufacturing operation and actively engage in plant safety initiatives and projects. Develop and maintain systems to monitor and proactively address equipment/process performance, including trend analysis and implementation plans.

Duties include: trim wet tissues, embed tissues into paraffin, tissue staining, microtomy, necropsy, and other basic histological duties

The QC analyst will join the Large Molecule team in the CMC division and will be responsible for performing analytical testing on large protein molecules (e.g. monoclonal antibodies, ADCC, biosimilars etc). This testing will be performed to support characterization, method validation, batch release and stability across pre-clinical, clinical and commercial release.

Crown Bioscience has an immediate opening for a full-time or part-time Research Associate in our In Vivo department. Responsibilities of the position include the handling, treatment, and monitoring of tumor-bearing mice.

We are seeking qualified individuals to join us as GMP Manufacturing Chemists at our Menlo Park facility. This position will be responsible for the synthesis and cleavage of peptides or the purification and lyophilization of peptides in our GMP manufacturing areas. Core duties and responsibilities include the following: Execute batch production records or protocols for synthesis and cleavage processes with minimal supervision in a timely and efficient manner, Analyze organic and inorganic compounds to determine chemical and physical properties, Operate laboratory equipment and instruments including: HPLCs, centrifuges, freeze dryers, stir plates, lab balance, mass spectrometers, sonicators, vacuum ovens, N2 tanks, etc.

Cyprotex US is looking for an Associate Scientist based in Watertown, MA to assume responsiblity for the routine screening of compounds in various in vitro toxicology assays and reporting to the Associate Director or Senior Scientist.  There will be no direct reports. Responsibilities include cell culture experiments, toxicology screens, validation/investigative assays, and experimental troubleshooting.

QA Operations Associate I is responsible for maintaining quality oversight of operational areas by working closely with Operation’s personnel and performing various checks during manufacturing processes to ensure that current Good Manufacturing Practices (cGMP’s) are followed. The QA Operations Associate I also assess regulatory and quality risks in activities and processes according to GMP and Cytovance Standard Operating Procedures. Duties include record reviewing, process audis, room releases, interfacing with various functional groups (manufacturing, QC, etc.), and support CAPA systems.

The Process Development Associate I conducts laboratory experiments in a productive manner with consistent quality and timely outputs, under supervision. Duties includes monitoring/executing experiments, keeping detailed written records in accordance with GDPs, and function independently in an lab environment.

As a member of the R&D Advanced Technology team, this Engineer will work closely with product designers from all technology areas (sensor, transmitter, software, etc.) to take the product through preclinical in-vivo feasibility.  This role will support the planning, development, and execution of pre-clinical models to evaluate prototype product.  This role will work closely with other engineers to determine the appropriate study design to evaluate the product, and this role will analyze/report study results.  Additionally, this role may also facilitate additional activities to support the product to begin testing in human clinical studies

The Regulatory Affairs officer is in charge of meeting regulatory expectations and ensuring compliance of In Vitro Diagnostic (IVD) products with national and international regulatory requirements. Key responsibilities include advising/assisting other departments (research and development, production, quality, marketing, sales, ...) with the various regulatory aspects related to IVD products, and to prepare regulatory applications: assessment of regulatory requirements according to the countries in which the product will be submitted: collection and compilation of information/data in collaboration with the other departments, redaction of submission files and management of shipments for the placing on the market of the product

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 in vivo (mouse) and in vitro methodologies. 

Duties as a tehcnical service associate include: project management (project plan, tracking of activities, material tracking, review scheduling), process validation activities (review/approve protocols, update manufacturing records), and continuous process verfication (protocol verification, data collection).

EAG Laboratories is looking for a Technician to join our team in Syracuse, NY. The Materials Laboratory Technician will be responsible for supporting Project Managers and Analyst activities. In this position, the individual will be using manufacturing, test, development, or diagnostic equipment, operate and maintain sample preparation related equipment. Also, prepare samples and equipment for analyses, including but not limited to, machining, mounting, and polishing, using techniques.

Editas is seeking a highly motivated Research Associate I/II to join our in vivo pharmacology group. The candidate will be responsible for conducting preclinical animal studies to support the development of gene-editing based therapies in multiple disease areas, including ophthalmology, oncology, and hematology. The successful candidate will be part of a dynamic team and will interact with the discovery, platform, process development groups, as well as contract research organizations.

In this role, you will contribute to the pre-clinical development of gene-edited cell products for oncology indications. An ideal candidate should have a background in immunology, cancer biology, and a strong interest in genome editing. Duties include basic molecular biology work, develop/perform immune cell activation, cytoxicity and other cellular/ELISA-based assays, and conducting cell based experiments. The successful candidate will be part of a dynamic team and will interact with the discovery, platform, process development groups, as well as contract research organizations.

This R&D engineering position is responsible for design and development experience in new medical device and product development. The R&D Engineer II supports new technology development by creating CAD models, prototyping new technologies, and executing performance testing. An Engineer II works through complex challenges and problems, communicates clearly, and works well in a team.

The Electrical Engineering will provide  project management support for the Clinton Laboratories plant site. Primary responsibilities include ownership, support and/or troubleshooting for the power distribution system, various control systems, energy initiatives, electrical safety programs, design and execution of small projects and participation in proactive asset maintenance reliability efforts for electrical equipment

Job activities include the preparation of equipment and components for aseptic filling operations, performing visual inspection of filled vials, vial labeling, vial packaging and distribution of filled vials as per GMP regulations. Execute daily tasks according to standard operating procedures in support of filling operations such as washing, cleaning and sterilizing equipment and components. Qualifies as an aseptic operator for the participation of filling activities using isolator technology.

The QC Analyst I - Chemistry will provide bioanalytical expertise for the Quality Control department.  Key areas of focus are development and implementation of the quality aspects of late stage or marketed product strategy.  This role is also responsible for maintaining sample traceability via QC logbooks. Responsibilities include: Testing responsibilities may include RP-HPLC, SEC, KF, FT-IR, SDS-PAGE, and UV-Vis. Assists with preparing new SOPs / test methods or revising of existing documentation.

Works in a hands-on capacity in the cGMP purification and production support areas to manufacture bulk drug substances. Supports necessary purification and production activities, including validation and development work as needed.  Works in hands-on capacity to operate chromatography systems, ÄKTA chromatography controllers, UF/DF skids, perform sterile filtrations, prepare production buffers, and clean equipment as required.

Endotronix, Inc. seeks a Manufacturing Engineer to join its Manufacturing team to assist with activities related to the development, manufacturing and validation of wireless implantable sensor products in Lisle, IL. Responsibilities include: Develop manufacturing processes including laser processing, dispensing, soldering, assembly processes and automated electrical testing, working to improve cost, manufacturability and lead time, and creating manufacturing documentation (Item Specifications/drawings, routers Manufacturing Process Instructions, Standard Test Methods, etc.)

This position is responsible for accurately and efficiently assembling in-house and OEM manufactured products, and providing support to the Production department to ensure timely production, product quality, and accurate maintenance of inventory. Responsibilities include: Fill and label kit components. Assemble immunoassay kits, chemicals, and other products. Perform OEM-related duties, including product re-labeling, assembly, and receiving. Operate automated filling machines and equipment. etc.

Project Coordinator assists in daily project management, including grant production, project schedual development, project budgets, project communication, and status reporting. Specific responsibilities include: identifying private/federal funding opportunities, establishing/maintaining grant submission processes, initiating inter-interstutional agreements, preparing letters of intent/support/CLs for PI, consultants, subcontractors, etc.

HPLC / UPLC Scientist responsibilities include, but are not limited to, the following: Conducts analysis and experimentation on formulated pharmaceutical materials in the laboratory with minimal supervision and using prescribed procedures, conducting independent chemical analyses of candidate formulations and working closely with formulators to streamline drug product development, evaluating “Fit For Purpose” analytical methods and working closely with the analytical method development team to streamline analytical method development, general knowledge of separations science and hands-on experience in chromatographic analysis, data interpretation and processing

Duties as an associate formulations scientist include: Preparation of prototype formulations (solutions, suspensions, tablets, capsules, powder blends, semi-solid dosage forms, sterile and non-sterile liquids) for exploratory studies in in-vitro and in-vivo models. Development of oral, topical and intravenous (sterile) dosage forms for feasibility studies and small scale manufacturing operations. Assessment of the chemical and physical stability of prototype formulations, as well as the performance of prototype formulations using in-vitro tests (non-sink dissolution, precipitation, etc.)

Eurofins Scientific is searching for an Associate Analyst I in Petaluma, CA. Title responsibilities include, but are not limited to, the following: ·Understand and follow Quality System documents relevant to responsibilities, e.g., Quality Manual, SOPs, and Methods. ·Adhere to, and assist laboratory staff in adhering to, appropriate quality measures to meet or exceed the standards set by ISO/IEC 17025, government regulatory (cGMP, GLP), and company requirements relevant to assigned duties. ·Adhere to all health, safety, and environmental regulations relative to assigned analyticl work; maintain and assist others in maintaining a clean, safe work environment. ·Perform timely and accurate analysis of samples to meet customer commitments, including but not limited to, preparing samples for analysis, using appropriate analysis methods and techniques, applying appropriate data review and reduction, and providing data interpretation and opinion.

As a QC Lab Technician you will provide basic laboratory test analyses, inventory lab supplies, and verify functionality of laboratory equipment. Responsibilities include: Perform Quality Control Tests on all raw material, in-process and finished samples brought to the lab per SOP’s and sample testing plans. Complete associated paperwork. Provide minimal guidance to Operations on corrections to batches to meet specification. Inventory laboratory supplies for all materials necessary to perform QC tests.

As a lab technician you will: Prevent release of material not meeting specifications and acceptance of raw materials not in specifications. Maintain inspection, measuring, and test equipment and perform verifications/calibrations in accordance with the plant quality system. Must also be aware of the regulatory requirements and must implement those standards as specified in the standards and regulatory requirements in this work assignment. Maintain a clean lab that promotes safe, accurate, and efficient completion of quality tasks. Assure material is of acceptable quality by performing necessary lab tests/inspections. Review the analytical results to determine if they are meaningful, accurate, and completed in compliance with the established Control Plan.

The Scientific Associate, Business Development will play a vital role supporting the Business Development/CDx Team. This position will report jointly to the Scientific Manager of the Business Development Team and to the Business Development Manager. Key accountabilities include handling logistical aspects of Pharma/CDx projects, developing and/or enhancing Scientific documents (SOWs, SOPs, presentations), Regulatory documents and Business Documents in support of Pharma/CDx projects in support the successful execution of CDx projects. Activities also include drafting and editing scientific and business presentations and marketing documents with the pharma audience in mind, assisting in CDx associated project management and oversight activities.

As regulatory representative for assigned clinical studies, provides representation for study-level regulatory activities and updates in study team management meetings, supports clinical trial application activities, reviews and approves investigator document packages including FDA and ex-US submissions, and manages other regulatory aspects of study as directed.

he research engineer produces specifications for, designs, develops, tests and optimizes the FRI technology. A person in this function performs research on new methodologies needed to address investigative questions. The research engineer combines these with medical science insights and data analysis strategies to come up with an optimal solution for every problem.

We are seeking a highly motivated Research Associate or Senior Research Associate with Peptide Chemistry experience to join our peptide medicinal chemistry team.  The individual should have experience in peptide synthesis and purification, peptide libraries, and the optimization of drug like properties with leading molecules. Primary job responsibilities include: Synthesis, purification and analytical characterization of peptides, small proteins and chemically-modified analogs using state-of-the-art synthesis and purification techniques. Program and operate instrumentation such as automated parallel peptide synthesizers, semi-preparative and preparative HPLCs, and an analytical LC/MS

Perform routine testing of in-process and finished product samples. Monitor environmental conditions in the production and lab areas. Summarize environmental monitoring and product test results. Provide project support to Scientist and Lead Scientist. Prepare media and reagents and equipment.

This position reports to the supervisor for the functional area to which they are assigned, and has no direct reports. The Associate Scientist position works closely with other departments, such as Operations, Validation, Product Development, Quality Systems, Product Release and Chemistry to assure the support of the Microbiology department on various projects, studies and routine tasks. The individual holding the position of Associate Scientist shall be responsible for coordinating the timely completion of routine and project testing. This person will also be responsible for coordinating the timely completion of routine and special finished product testing and environmental issues. They will assist with the training of Production and Quality Control personnel in microbiological tests and methods.

Responsibilities as an associate scientist-product development include: Perform assigned tasks per procedures compliant with cGMPs and participate in the clinical manufacturing of parenteral, ophthalmic, and other sterile dosage forms, Assist with manufacturing area maintenance such as area monitoring and qualification, purchase of gowning supplies, purchase of equipment and room cleaning supplies, microbiological monitoring supplies, Execute product development studies under the guidance of supervisor or lead project scientist to support formulation development (R&D), and clinical drug product manufacturing

Performs routine sample analysis and a variety of tasks to support product development, ensuring agreed timelines, assists method development

The successful candidate assists in the planning of, conducting, evaluating, and interpreting routine laboratory experiments. The individual monitors on going experiments and identifies and resolves or suggests alternates or solutions to complex occurrences. The individual understands and applies use of equipment, technology and materials associated with area of expertise and related studies and projects. The individual takes a more active role in non-routine analytical or process development activities.

The ideal candidate works independently and with colleagues to provide assistance for the design, development, standardization and maintenance of an operational biotechnology utilized in the manufacture of proteins and drug substances. This person would become familiar with a variety of core manufacturing and operational technologies including equipment used in: Fermentation, Cell Culture/Single Use Technology, Filtration, Centrifugation and Chromatography, Mixing and Buffer Preparation, Parts washing and Sterilization, and Homogenization

The Analytical Methods Transfer group is seeking an energetic Associate Scientist with protein chemistry experience to become an integral member of a high performing method transfer team supporting protocol based activities including technical transfer of methods from donor labs as well as training of colleagues for internal transfer, and qualification, validation and verification of methods. The successful candidate will primarily execute biochemistry based techniques such as UPLC/HPLC (SEC, IEX, RP, glycan, affinity, etc), capillary electrophoresis (icIEF, CE-SDS), gel electrophoresis, western blot, plate based assays and spectrophotometry (SoloVPE) for the characterization and testing of recombinant protein pharmaceuticals.

Fulcrum is seeking a Bioinformatics Engineer to (1) implement and manage lab informatics software applications utilized across research teams and (2) build and sustain custom software in the Computational Biology group. Lab informatics includes applications such as GeneData, Dotmatics, LIMS-biorepository systems, cheminformatics tools, and relational databases. Working closely with the IT/Operations and Molecular Sciences groups at Fulcrum, this individual will manage these applications on the cloud in a secure manner, serve as the point of contact with application vendors, organize training, and operate on an efficient budget. Custom software development within Computational Biology will be focused on, but not limited to, molecular profiling pipelines.

The Laboratory Technician performs an entry level role in the testing of clinical DNA specimens for the purpose of diagnosing genetic disease, using manual and automated methods in a team environment, and following established policies and procedures in a professional manner. Responsibilities include: Implements standard operating procedures for specimen handling and processing, Assess and process prenatal specimens for DNA extraction and sendout testing

Responsibilities as a sales associate include: Achieve annual sales goals within defined territory/accounts through the development, maintenance, and enhancement of customer accounts, Retain current business baseline revenue by managing relationships with customers and other account contacts by collaborating with business leaders and the customer interface teams and, Drive the marketing process for the territory by creating a marketing plan, registering/planning/ attending local vendor shows, and working with Marketing to follow up on leads from email campaigns

Essential Duties and Responsibilities: Responsible for day to day running of experiments and data analysis, conducts general molecular biology tasks, including nucleic acid purification, quantification, amplification and analysis on multiple platforms, prepares reagents and solutions as needed, using appropriate procedural and documentation methods, maintains stockroom supplies and inventory, prepares documents meeting company standards, including data summaries, reports, SOPs and procedures, presents work at meetings as required, and proposes new strategies and methods to address immediate and upcoming technical issues

The Sample Processer’s primary responsibility is to provide front-line support in the procurement of record of loan (ROL) material and manage chain-of-custody of samples received.  This individual must support the GenomeDx internal and external customers in the routine functions to ensure client satisfaction and appropriate records and materials management are consistently maintained.  This individual must work with staff to employ a team approach.  Manages patient orders with or without samples and oversees special projects assigned by their supervisor.

GigaGen seeks a talented, highly motivated Research Assistant to work alongside PhD-level scientists on research. This project involves high-throughput discovery and development of therapeutic antibody drug candidates from human and mouse immune repertoires. The work involves significant cell culture work, including a bioreactor and flow cytometry.

Must meet all requirements for Clinical Project Assistant position and have demonstrated proficiency in all relevant areas

We are looking for someone who is excited about the field of synthetic biology and loves a challenge.  Responsibilities include enzyme purification and characterization. We want a person who is eager to learn and has a desire to utilize automation to work more efficiently. Our ideal candidate will elevate our team through creative solutions while working closely with other foundry groups.

Pharmacovigilance Scientist. Jobs located in Edison, NJ. Review non-serious and serious AEs and aggregate AE listings. Prepare signaling meeting presentations in collaboration with the team, including a review of events of interest, initial trending of AEs, set thresholds for escalation, and preparation of meeting minutes. Monitor the safety profile of assigned compounds to identify any safety signals and support execution of plans for signal evaluation.

Global PharmaTek, LLC has job openings for Drug Safety Associate.Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.Receives clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements, obtaining follow up as needed; ensure that all SAE’s are complete prior to database closure Process and distributes clinical study SAE reports as per the company SOPs Completes AE/SAE reconciliation prior to clinical trial database closure Receives, processes, and distributes spontaneous adverse event reports for marketed products, both serious and non-serious, as per the company’s SOP’s .Processes all types of adverse event reports utilizing the ARIS safety database Assists with preparing and/or reviewing safety summaries for Investigator Brochures and annual reports, safety submissions for marketed products, and other safety reports as needed or requested

As an industiral engineer you will be responsible for: leading cross functional operation projects, drive financial analysis, ensure execution of quantitative project management deliverables within projects such as project cost benefit analysis and metrics of project success, etc.

Responsibilities as an associate biochemist include: coordinating routine in-process biopharmaceutical materials, bulk bio-pharmaceutical ingredients, finish bio-pharmaceutical products/stability sample testing. Conduct/document routine compendial, chemistry, immunology and molecular biology analytical testing for in-process, release and stability samples per SOP. Operate/aintain QC lab equipment.

The successful candidate will join a Product Development Team within the Biopharmaceutical Product Sciences (BPS) department of the Biopharm Product Development & Supply organization within GSK R&D. The candidate will focus on developing protein formulations, assessing product stability, implementing biopharmaceutical drug product manufacturing processes, and when applicable, coordinating with Device Engineering for implementation of drug delivery devices. The scientist in this role may be expected to contribute to cross-functional initiatives and/or rotate between other BPDS departments to support a flexible product development initiative.

As Value Stream Manufacturing Associate you will manage/lead/be responsible for performing duties as assigned with respect to quality, timeliness, quantity and cost. Work individually and as a team to deliver cGMP compliant product.  Adhere to GSK policies, procedures and support site goals.  Complete documentation in line with regulatory, GSK, and departmental requirements.  Work and communicate closely with other departments both inside and outside of the Value Stream.

The Research Associate will be a member of the Product Development team at Halozyme and will be responsible for performing analytical testing support, method development, and qualification for in process, drug substance and drug product samples from a variety of drug development programs. Analysis will cover a wide array of analytical techniques such as UV/Vis, ELISA, potency, HPLC, CE, icIEF and wet-chemistry. This individual will also be involved with data verification of laboratory notebooks, protocols, reports, and regulatory filings to ensure the accuracy of the record and to meet critical timelines.

As a process development technician you will be responsible for production of products and to support the scale-up process of new products meeting customer specifications and performance requirements. Projects involve establishing standard operating procedures for new products or product modifications. Additional responsibilities include: Control or operate equipment in which chemical changes or reactions take place during the processing of products and pilot scale evaluations, interpret process data trends, developmental results, and statistical analysis, and draw samples of products for the Analytical Department at specified stages so that analyses can be performed for specific chemical characteristics such as pH levels, concentrations, or viscosities.

Manage the ideas to launch process and NPD Project Management Team with an approach focused on cross-functional team coordination. Support CSO with general process and budget management for the R&D function. Responsibilities include portfolio management, managing team, planning/reporting projects, and creating timelines.

To perform routine, work-flow processes within the quality control laboratory to meet customer requirements by supporting the testing of raw materials and finished products while ensuring regulatory compliance standards and release times are met. 

Perform functions within the Microbiology Laboratory related to Environmental Monitoring of controlled production areas. The duties also include equipment maintenance and LIMS management.

Coordinates documentation and facilitates communications regarding the required documentation of pending, in progress and completed installations of Clinical Workflow Solutions products. Reviews all documents related to the CWS Device History Records prior to submission to document control in accordance with FDA acceptance activities standards. Responsible for reviewing and processing certification documents associated with CWS implementation and service work orders. Daily interfaces with field service personnel, project management and document control to complete required tasks.

The Associate Product Manager will support the Brand and Integrated Marketing teams for the Hologic Surgical Division through collateral and campaign development, daily product management needs, and through the creation and management of small digital marketing campaigns. This role's responsibilities include: Support brand leads throughout the supply chain process, ensuring consistent communication to internal and external stakeholders as needed. Contribute to marketing activities, including collateral creation and promotion/campaign assistance related to the promotion of the Office access tools business, as well as MyoSure and NovaSure as needed

Hologic is seeking a Research Associate 1 responsible for designing and performing experiments while collaborating and communicating effectively. Duties & Responsibilities: Performs minimally complex experiments with input from supervisor. Understands experimental goal and may provide input to the experimental design. Analyzes data from individual experiment with input from supervisor and documents work in laboratory notebook or report. Able to summarize a group of experiments. Effectively communicates with peers and supervisor. May present data in group meetings.

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).

ICON, a leading Clinical Research Organization, is seeking passionate, resilient and inspiring Graduates to join our team as a Clinical Trial Assistant. This opportunity offers an entry-level permanent position to highly skilled individuals interested in a career in clinical research.

Our Quality Assurance Auditor will assess the compliance of ICON Laboratories to all federal/state of New York, US FDA GLP regulations, ICH E6(2) regulations, adherence to Guidance for Industry documents and ICON quality standards as well as assist with developing Standard Operating Procedures.

The R&D Engineer is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices. The key responsibility of this position is the design, development, and improvement of product lines to ensure their efficiency and reliability. The incumbent will be heavily involved with plastics, polymers, molding, medical disposables, plastics engineering, and solid modeling. The R&D Engineer will be expected to interface with customers and suppliers on high-volume disposable medical device design.

As a production planner you will analyze, plans and prepares production schedules for manufactured products within the production facility to meet customer demand. Draws up production schedules to establish sequence and lead time of each operation to meet shipping dates according to sales forecasts and/or customer orders. Analyzes production specifications and plant capacity data and performs mathematical calculations to help determine manufacturing processes, tools, and human resource requirements. Gathers performance data and assesses whether or not departments are performing according to production schedules. Produces reports that evaluate plant capacity and identify areas where improvements can be implemented.

As a mechanical engineer, individual duties include: develope/execute new product plan in accordance with Pulsafeeder processes, works with marketing to generate product specifications, designs reliable and cost-effective products, etc.

The Synthesis Scientist I synthesizes custom oligonucleotides according to the customer’s order.  This generally includes synthesis, cleavage, deprotection and QC sampling of the products being made. Other responsibilities include adherence to lab SOPs, maintaining lab equipment/stock, keeps record of specalized processes for oligo, etc.

The Manufacturing Chemist efficiently produces high quality materials for use in IDT’s production labs. Essential Functions include: monitoring inventory, follows processes for manufacturing/storage/transportation, gathers/interprets/analyzes oligo data, maintains accurate/detailed product/process, intstrument and training.

We are seeking a Systems Engineer 1 to help us build the next generation of clinical diagnostic tests. This position work with external and internal partners in Operations, R&D, and Software Development to develop new laboratory automation and diagnostic equipment. This engineer will focus on development and system testing activities for our sample preparation systems. Responsibilities include: Participate in development of consumables, assay automation processes to accomplish development and product goals. Conduct screening and troubleshooting experiments to assess the technical capability and performance of assay, robotic, fluidic, sensor, and instrumentation sub-systems and systems, collaborating with senior engineers and scientists.

The primary purpose of the Laboratory Support Assistant position is to provide support to the research and manufacturing teams to assist in laboratory maintenance and logistics coordination. In addition, provide support to the clinical team in support of adoptive cellular therapy (ACT) clinical trials. This position will report to the Director QA/QC. The primary purpose of the Laboratory Support Assistant position is to provide support to the research and manufacturing teams to assist in laboratory maintenance and logistics coordination. In addition, provide support to the clinical team in support of adoptive cellular therapy (ACT) clinical trials. This position will report to the Director QA/QC. The primary purpose of the Laboratory Support Assistant position is to provide support to the research and manufacturing teams to assist in laboratory maintenance and logistics coordination. In addition, provide support to the clinical team in support of adoptive cellular therapy (ACT) clinical trials. This position will report to the Director QA/QC. The primary purpose of the Laboratory Support Assistant position is to provide support to the research and manufacturing teams to assist in laboratory maintenance and logistics coordination. In addition, provide support to the clinical team in support of adoptive cellular therapy (ACT) clinical trials. This position will report to the Director QA/QC. 

As a Red Blood Cell Processing Technician, you will perform production tasks in a clean-room environment. In addition, it will be your responsibility to ensure that your work is consistently in compliance with Good Manufacturing Practices and Good Documentation Practices. Additional duties include: Performing blood processing operations according to corporate policies, operating procedures, specifications, and verbal work instructions. Ensuring that blood products are transported, processed and stored in a manner that prevents contamination.Following appropriate control measures to prevent mixing of dissimilar production components in compliance with Good Manufacturing Practices

ImmunoGen is seeking an experienced and talented professional to join the department of Analytical & Pharmaceutical Sciences (APS) to advance ImmunoGen’s key development programs of our Antibody Drug Conjugates (ADCs). The Research Associate will work with other internal development functions (e.g., Process Development) to perform high throughput purification and related analytical testing of development samples.

The Cell Culture Technologist, Upstream Process and Manufacturing Sciences is responsible for participating in the operation of mammalian cell culture processes under cGLP conditions. Responsibilities include: Prepares and maintain cGLP research cell banks. Performs cell culture expansion under cGLP for cell culture in benchtop bioreactors and shake-flasks.Strong aseptic techniques and demonstrated ability in documentation and knowledge of cGMP/cGLP cell culture development.

The Pharmaceutical Formulation Technician will conduct formulation and process development for powder and liquid nasal dosage forms under the supervision of the Pharmaceutical Formulation Scientist. Responsibilities include: Conduct laboratory experiments under the supervision of the formulation scientist. Assist technical staff in the development of Impel’s drug formulations.

The Staff Scientist, Pharmacokinetcs schedules and monitors Discovery pharmacokinetic studies, provides dose formulations, and completes general lab work.

Assists with the development of new or improved autoimmune diagnostic assays according to established procedures. Major research and development duties include assistance with reagent formulation and optimization of existing formulations. Additional duties involving organizing and facilitating timely progress and completion of projects will be assigned.

Assists with the development of new or improved autoimmune diagnostic assays according to established procedures. Major research and development duties include assistance with reagent formulation and optimization of existing formulations. Additional duties involving organizing and facilitating timely progress and completion of projects will be assigned.

Assists technical support with investigation of complaints according to established procedures. Assists with the design changes of current products according to established procedures by improving or developing new procedures. Major development activities include assistance with process validation, equipment validation and evaluation of vendor samples.

The Assistant, Clinical Trials (CTA) is responsible for supporting, under the direct supervision of the supervisor/Clinical Project Lead (CPL), clinical trial execution, externally sponsored research and program level activities as assigned within Clinical Operations at Inovio. This position assists in various tasks and projects related to clinical trials as well as basic, administrative duties such as ordering drugs and devices, maintaining milestone trackers and filing of essential documents of externally sponsored trials.

The primary purpose of this position is to develop the risk-based supplier management process, lead the critical supplier-related projects, and support daily supplier non-conformances and requests for change. This position will also be responsible for performing GMP/ISO audits on suppliers, proposing improvements to their quality system and tracking the closure of any audit related non-conformance. 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 the risk-based supplier management process, lead the critical supplier-related projects, and support daily supplier non-conformances and requests for change. This position will also be responsible for performing GMP/ISO audits on suppliers, proposing improvements to their quality system and tracking the closure of any audit related non-conformance. 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 the risk-based supplier management process, lead the critical supplier-related projects, and support daily supplier non-conformances and requests for change. This position will also be responsible for performing GMP/ISO audits on suppliers, proposing improvements to their quality system and tracking the closure of any audit related non-conformance. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.

Develops new or makes improvements to existing weld equipment or processes verifying proper operation.

As a Microbiologist I, duties include: Ensure compliance with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive. Perform and document in-house microbiological testing on all in-process and finished products to comply with acceptance requirements. Perform LAL, water analysis, growth promotion, gram staining, identification of microorganisms and other microbiological testing. Perform and document environmental monitoring in compliance with Standard Operating Procedures. Report any equipment and testing deviations to the Supervisor. Submit samples for shipment to third party labs when necessary. Maintain GMP/GLP laboratory notebooks and documentation relevant to the duties and responsibilities assigned.

Duties and functions include: assemble study designs, perform laboratory experiments, organize data, and analyze results under minimal supervision, set up/perform HPLC as well as other assays to characterize protein/peptide molecules, analyzes data, etc.

Install and support the Intuitive Surgical products and ensure service agreements and warranty obligations are fulfilled.  Exceed customer expectations and maintain customer satisfaction to the highest possible level. Pre site verifications to prepare site for system installation. Assist in coordination of system delivery (e.g. confirming site readiness). Perform system installations. Install system upgrades. Provide technical and clinical support to end-users and other ISI employees. Train customer on new features or enhancements made to existing features. Install and support the Intuitive Surgical products and ensure service agreements and warranty obligations are fulfilled.  Exceed customer expectations and maintain customer satisfaction to the highest possible level. Pre site verifications to prepare site for system installation. Assist in coordination of system delivery (e.g. confirming site readiness). Perform system installations. Install system upgrades. Provide technical and clinical support to end-users and other ISI employees. Train customer on new features or enhancements made to existing features.

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.

The Process Development Associate I will provide analytical support to development and research projects, including but not limited to: assess data integrity and accuracy through data audits, data surveys, and final data audit reports.

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. Using monitoring tools, pro-actively identify trends and provide feedback to internal departments and/or client on performance of both the Investigator and the Q2 Solutions services to ensure timely service delivery. Examples may include:

Statistical Programming projects vary, your typical responsibilities and opportunities might include: Programming all aspects of a clinical trial, from files to tables, listings and figures Using SAS in a quality control and production capacity Programming from scratch as well as updating existing programs Developing specifications for analysis files and annotating output shells for programming instruction and documentation Working and communicating effectively in a team environmentStatistical Programming projects vary, your typical responsibilities and opportunities might include: Programming all aspects of a clinical trial, from files to tables, listings and figures Using SAS in a quality control and production capacity Programming from scratch as well as updating existing programs Developing specifications for analysis files and annotating output shells for programming instruction and documentation Working and communicating effectively in a team environment

We are seeking an individual to perform applicable testing on raw, in-process, and final products to insure material quality as well as to perform tests for monitoring environmental conditions and water quality. Responsibilities include: testing raw, in-process and finished products. Testing environmental conditions, testing water systems, calibrating and maintaining instrumentation, etc.

TheRegulatory Affairs & Pharmacovigilance Associatesupports the regulatory compliance and pharmacovigilance programs by coordinating the scheduled activities of state and federal reporting, as well as medical complaint handling, ensuring compliance with US and International regulatory agencies. This individual evaluates both the compliance and medical complaint report information in order to plan appropriately, request information, and maintain schedule adherence. Responsibilities also include eSubmissions and the assurance that assigned departmental procedures are developed and maintained in accordance with US and/or global regulatory requirements as well as enhancing regulatory compliance systems and strategies.

Just is seeking a motivated and creative scientist who desires a significant opportunity to improve worldwide access to biotherapeutics. In this position, you will work with a multidisciplinary team for the analytical and functional biocharacterization of large molecule therapeutics and analysis of process impurities. Experience with HPLC and CE methods, DNA extraction, PCR and ELISA binding assays preferred. Cell-based and ligand-receptor binding assays, as well as high-throughput methods and liquid handling robotics beneficial. The successful candidate has strong written and verbal communication skills and is interested in ways to improve technology. The ability to multitask and to work both independently and in teams in a fast-paced collaborative environment is necessary.

Just is seeking a highly motivated entry-level manufacturing Process Engineer(s) that desires a significant opportunity to improve worldwide access to biotherapeutics. This team member will be responsible for the manufacture of mammalian cell-based biotherapeutics for clinical use under cGMP conditions. Under direct/moderate supervision, job responsibilities include set-up, operation, and maintenance of disposable-based manufacturing equipment; execution of manufacturing process operations; and assist in general lab operations. The staff member is expected to comply and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation.

Just is seeking a motivated and creative scientist or engineer who desires a significant opportunity to improve worldwide access to biotherapeutics. The new scientist/engineer will join a fast-paced, collaborative, and multidisciplinary team to develop purification processes for low-cost biotherapeutic manufacturing. The successful candidate will have experience in chromatography and filtration theory and operations. Experience with high throughput chromatography screening, chromatography mechanistic modeling, multicolumn chromatography and/or process modeling is a plus. The ideal candidate has strong written and verbal communications skills, works well independently and in teams, and constantly looks for ways to improve processes and technology.

We are looking for a Jr.-level applications developer to design, build, modify, deploy, and support custom applications to complement existing syndicated applications per our client’s needs.

A Scientist will be a key technical resource responsible for independently developing methods, generating reliable and interpreting data, using analytical instrument that include HPLC, UPLC, GC, UV/Vis, Mass spectrometer, dissolution apparatus and particle analyzer. This position is also responsible for designing experiments, writing method validation protocols, conducting method validation, and processing and interpreting the analytical data.

Responsible for executing experimental protocols and performing elementary data analysis in biopharmaceutical development laboratories. Understands experiments and conducts troubleshooting analysis. Regularly exercises technical discretion in the execution and interpretation of experiments that contribute to project goals. Assures proper labeling, handling, and storage of all chemicals used in the area; assures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures, and attends all required safety and health training, including handling hazardous waste.

The Analyst I is responsible for preparation of reagents and solutions, as well as sample processing under required regulatory documentation. May also analyze data, interpret results or contribute to troubleshooting activities. Conducts sample inventory and carries out lab support duties as assigned, such as inventory of chemicals, washing glassware, waste disposal and/or general cleanup.

The incumbent in this position is responsible for all production activities at KLS. Directly reporting to the Production Manager and working with the QA/QC analysts, this position will also ensure all production process are documented and executed accurately according to established SOPs. The ideal candidate is a chemist with at a minimum of one year of experience in production of chemical compounds, preferably in a GMP environment.

The successful applicant will work with internal functional groups to help design and execute screening strategies for therapeutic antibody discovery campaigns – including biochemical, molecular, and/or cellular assays for the testing of biotherapeutics from discovery to lead-optimization. Work with internal functional groups to develop, optimize and execute high throughput binding assays (ELISA, Octet, FACS) and cell-based assays (functional, phenotypic, reporter etc.) for screening panels of therapeutic antibody candidates

Prepares laboratory specimens for analysis and testing. Spinning samples, pouring urine tubes and creating frozen samples. Picking up and delivering samples to clients/hospitals. Unpacks and routes specimens to their respective staging areas. Accurately Identify and label specimens. Pack and ship specimens to proper testing facilities.

Prepares laboratory specimens for designated departments/locations prior to laboratory analysis and testing. Unpacks specimens from branches or ports and routes specimens by type to various staging areas. Prepares all specimens received for testing in designated laboratory departments or locations such as staging of specimens, centrifuge, separate serum, and blood smears. Aliquots sample for departments. Prepares excess specimen samples for storage and resolves and document problem specimens.

Responsibilities include but are not limited to: Maintain laboratory instruments, follow SOPs for mammalian cell culture and protein/antibody purification, conduct data input, analysis, and interpretation, think critically and creatively to determine appropriate resources for resolution of problems, recognize and trouble shoot anomalous and inconsistent experimental results.

A successful candidate will possess proficiency in a variety of analytical chemistry techniques including HPLC. The position of Research Associate will report to a Formulation Scientist. Responsibilities include: assist the supervising Formulation Scientist to complete individual formulation development projects, assist in the design, execution and interpretation of formulation development based on the defined deliverables, as well as in the planning of activities to meet the project timelines, and prepare presentations of data and progress and assist in regular presentations to external clients during formulation development projects

We are seeking individuals who arepassionate about research, bringout of the box thinking and take bold steps todevelopinnovativetechnologies with applications in the ubiquitin research field.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.

Execute virus media development projects. Data analysis and report writing. Troubleshoot problems in manufacturing and QC for virus media.

Filtering finished latex from reactors to storage, including: the verification that latex is within all specifications, calculation of correct storage tank capacity, proper sampling and record keeping (valve placement sheets, shift log, filing charts, etc.). Manufacture, packaging and shipment of customer bulk orders, including: the calculation of correct tanker outage/inage, inspection of tanker, proper sampling, completion of weight ticket and bill of lading. Manufacture, packaging and shipment of customer drum orders, including: proper sampling and labeling, completion of packing list and bill of lading and the proper use of forklift.

The International Sales Coordinator provides administrative and management support to LGC, Biosearch Technologies' distribution network, both domestic and international, as well as support to international customers. This position requires excellent customer interaction with both internal and external customers. Responsibilities include: Respond to distributors' inquiries regarding pricing, marketing tools, re-direct technical questions, or special projects such as logistics planning & preparations for distributor meetings, Capture marketing and sales announcements, or corporate updates to develop monthly newsletter for distributors and distribute the newsletter in electronic format to entire distribution network, etc.

Manage, coordinate, and maintain CGMP documentation, electronic and/or paper based, procedures, and records to ensure only controlled copies are reviewed, approved, issued, distributed, and archived.

Conducts sampling of incoming raw materials, production environments, and/or facility clean utilities, as per approved procedures and submits these samples to the appropriate testing facility for documented and controlled results. Applies material / system status labels, as indicative of testing status and/or results obtained. Assists with lab maintenance and inventory.

Review all records associated with the manufacturing of a product lot for completeness and accuracy to ensure qualified specifications, parameters, and controls have been met and/or all deviations from such have been adequately and timely addressed.

This position provides QA support in the manufacturing of clinical and commercial drug products/medical devices to ensure compliance with the principles and guidelines of cGMP. QA Associates maintain the quality systems, such as laboratory control, investigation management, materials management, document control and training to ensure control of the manufacturing process. This position will actively partner with Manufacturing Operations, Facilities, Materials Management, and other supporting departments to provide compliance and technical guidance to ensure quality issues are identified and resolved in a timely manner.

Mammoth is seeking a Research Associate experienced in protein and nucleic acid biochemistry techniques to work with our CRISPR development team. The ideal candidate will have experience with protein engineering, molecular biology, protein purification and bioinformatics. Further, the candidate will be comfortable working as part of a team, be highly motivated, and display excellent time management skills. The Research Technician will report directly to a Scientist.

Manus Bio is a next-generation industrial biotechnology company based in Cambridge, Massachusetts that produces plant-based ingredients. We use a variety of patented and proprietary technologies for engineering microbes for the production of specialty chemicals, such as food ingredients, agricultural chemicals, and pharmaceuticals. We are seeking a motivated individual for a research assistant position that will specialize in molecular biology and natural product discovery. This person will be expected to tackle a variety of challenges as an integral part of Manus Bio’s R&D team.

This position is responsible for ensuring all incoming customer product is correctly inspected, inventoried and accurately entered into the electronic inventory system.  This includes initially entering data and being a secondary reviewer.  Duties include abiding by area work instructions and ensuring that customer product is stored at appropriate conditions during inventory to ensure compliance. Communicate with appropriate personnel to determine all pertinent information that needs to be captured

The Clinical Laboratory Scientist I (CLS I) performs a variety of both routine and complex clinical laboratory tests in accordance with established processes and procedures. These require professional level of knowledge to properly execute and analyze results, especially where results are abnormal or atypical. Responsible for compliance to all applicable regulations including but not limited to the Food and Drug Administration, ISO and State and Federal requirements.

his is a hands-on laboratory-based position to support pre-clinical research to further our understanding of the disease-driving mechanisms and to develop new medicines for respiratory diseases such as COPD, asthma, and pulmonary fibrosis. The candidate will assist in study design, execution and data analysis of complex and technically demanding in vitro and in vivo experiments using a variety of cellular and molecular techniques.  The candidate will develop close working relationships within a highly collaborative environment using strong interpersonal and communication skills to advance team goals. his is a hands-on laboratory-based position to support pre-clinical research to further our understanding of the disease-driving mechanisms and to develop new medicines for respiratory diseases such as COPD, asthma, and pulmonary fibrosis. The candidate will assist in study design, execution and data analysis of complex and technically demanding in vitro and in vivo experiments using a variety of cellular and molecular techniques.  The candidate will develop close working relationships within a highly collaborative environment using strong interpersonal and communication skills to advance team goals. 

This role will contribute in the development of product requirements, generate and evaluate device concepts, conduct engineering analyses, develop detailed engineering specifications, create device designs, and perform design verification/validation testing in a cross-functional team to ensure successful development and launch of mechanical and electro-mechanical medical devices. This role requires excellent technical writing skills and good understanding of design control process. 

The successful candidate will carry out bioanalytical cell based assay testing of recombinant protein therapeutics under cGMP. The ideal candidate will make detailed observations, analyze data, interpret results, and exercise appropriate technical discretion in the design, execution, and interpretation of experiments in an independent manner.This person may be involved in the qualification and validation of cell-based bioassays for biological characterization and testing of biopharmaceutical products, and assist in assay investigations and troubleshooting. He/She will perform cell culture, maintain cell lines and perform routine lab equipment maintenance. The candidate will be expected to prepare technical reports, SOPs and technical summaries for meeting presentation. The candidate will be expected to assist/lead investigation for non-conformances and coordinate equipment validation with different departments.

As a Production Technician II in Frederick, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca/Medimmune is a truly world-class business unit. 

The ideal candidate will make detailed observations, analyze data, interpret results, and exercise appropriate technical discretion in the design, execution, and interpretation of experiments in an independent manner.  This person may be involved in the qualification and validation of cell-based bioassays for biological characterization and testing of biopharmaceutical products, and assist in assay investigations and troubleshooting. He/She will perform cell culture, maintain cell lines and perform routine lab equipment maintenance. The candidate will be expected to prepare technical reports, SOPs and technical summaries for meeting presentation. The candidate will be expected to assist/lead investigation for non-conformances and coordinate equipment validation with different departments. The successful candidate must have excellent written and oral communication skills, good time management and outstanding multi-tasking abilities, and the ability to work in a cGMP environment and a fast-paced team-centered setting. The candidate will be expected to present findings at internal and/or external meetings.

Primary trainer of those with less experience, Execution of validation protocols.

Develop downstream processes for the manufacture of biopharmaceuticals (monoclonal antibodies and other proteins).

This is a hands-on laboratory-based position to support pre-clinical research to further our understanding of the disease-driving mechanisms and to develop new medicines for respiratory diseases such as COPD, asthma, and pulmonary fibrosis. The candidate will assist in study design, execution and data analysis of complex and technically demanding in vitro and in vivo experiments using a variety of cellular and molecular techniques.  The candidate will develop close working relationships within a highly collaborative environment using strong interpersonal and communication skills to advance team goals. 

Review third party contracts for business implications and acceptable predefined legal terms; Utilize governance, risk, and compliance (GRC) software to contribute to contract management and third party information; Employ risk analysis processes in the performance of third party due diligence; Apply understanding of policies and procedures associated with purchase contracts such as indemnification and amendments; Review third party performance ensuring that contract KPI’s are achieved and develop relevant improvement plans in collaboration with the operations teams; Analyze financials to assist in negotiation of agreements; Prepare and coordinate third party requests for proposals; and May be responsible for other projects and responsibilities as assigned. Review third party contracts for business implications and acceptable predefined legal terms; Utilize governance, risk, and compliance (GRC) software to contribute to contract management and third party information; Employ risk analysis processes in the performance of third party due diligence; Apply understanding of policies and procedures associated with purchase contracts such as indemnification and amendments; Review third party performance ensuring that contract KPI’s are achieved and develop relevant improvement plans in collaboration with the operations teams; Analyze financials to assist in negotiation of agreements; Prepare and coordinate third party requests for proposals; and May be responsible for other projects and responsibilities as assigned.

Reviews sterile load cycle data and performs sterile load release for finished product lots manufactured by Medtronic Danvers or contract manufacturers. Administers the Environmental Monitoring Program for the Danvers manufacturing areas including viable and non-viable particulate counts, product bio-burden, water and surface microbial levels, etc. to ensure an appropriately controlled environment meeting regulatory expectations and industry standards. Communicates detailed information regarding monitoring results and trends to Manufacturing and Quality; recommends revisions to monitoring program and/or manufacturing process controls and ensures effective corrective actions are implemented, where necessary.

esponsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Provide Quality Engineering support as a Process Validation team member and lead/execute Test Method Validations and Measurement Systems Analysis (MSA).esponsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Provide Quality Engineering support as a Process Validation team member and lead/execute Test Method Valida

We are seeking a hands-on Manufacturing Engineer to work closely with R&D, Operations and Quality in the development of new processes necessary to produce Catheters/Delivery Systems/Stents for a lean manufacturing environment. Manage development builds, develop new manufacturing processes, implement and qualify production equipment and methods, generate testing protocols and reports, and work with minimal direction for NPI.

Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality Performs chemical evaluations of new and existing products and processes.

The Associate Materials Engineer responsibilities include but are not limited to support various manufacturing sites for Medtronic devices. This includes working with Seniors Engineers and participating in cost savings, redesigns, manufacturing process improvements, tooling replacement projects and resolving production issues related to metal and/or plastic components. The Associate Materials Engineer will not only need to follow but to help develop new company’s best practices and standard procedures. The Associate Materials Engineer must be able to communicate technically with various suppliers for Medtronic to support troubleshooting, supplier development programs and tooling replacement programs to ensure quality components will continually be received timely at the manufacturing sites.

Provide engineering support in the concept, prototyping, clinical evaluation, process/equipment development and production scale up of new products and components from R&D, Supply Chain, manufacturing transfers and business acquisitions. Provide engineering support in product transfers from R&D to Manufacturing. Provide engineering support in product line transfers from outside facilities to internal manufacturing in Massachusetts. Provide engineering support in product line transfers from current manufacturing to outsourced manufacturing vendors. Provide engineering support scale up of component manufacturing for other businesses within Medtronic. Provide engineering support for development and scale up of low cost manufacturing for legacy product lines. Define equipment, process, material and operator specifications for manufacturing. Approach all engineering activities with the objective to reduce variability in operator, materials, machines and manufacturing processes to improve profitability at the Danvers site.

We are seeking a hands-on Manufacturing Engineer to work closely with R&D, Operations and Quality in the development of new processes necessary to produce Catheters/Delivery Systems/Stents for a lean manufacturing environment. Manage development builds, develop new manufacturing processes, implement and qualify production equipment and methods, generate testing protocols and reports, and work with minimal direction for NPI.

The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise.  Specific assignments may be focused in one area or span across multiple areas of focus. Candidates will be responsible for: Provide on-the-floor support of operational and technical issues; collaborating with the shop floor to provide immediate responses to deviations and potential deviations. Performing deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc 

The successful candidate will be expected to be a first responder to requests from the manufacturing areas when support is needed. The well-qualified candidate must have analytical, problem-solving, and communication skills. In this role, the candidate will provide support for the manufacturing of aseptic products.

The Quality Assurance Associate works within the Teutonia QA team to ensure that the site meets customer and Life Science quality requirements. Responsibilities will include reviewing/updating procedures, providing training on quality-related topics, performing self-assessments and internal audits, assist with/or lead investigations/root cause analyses/CAPAs for customer complaints or other internally identified issues. Ensure that all aspects of product release meet analytical, production, packaging and labeling specification in accordance with established quality systems. Support the maintenance, development and improvement of GMP and/or ISO-9000 quality systems, such as auditing (internal, supplier, and customer), training, change control, complaint handling, and documentation control.

Within the Biodevelopment Process Development group, will execute projects including developing purification processes and analytical methods for a variety of therapeutic candidate proteins including monoclonal antibodies and Fc fusion proteins. The scope of work includes protein purification, biochemical and biophysical characterization, as well as to develop, validate and transfer robust analytical methods required for successful drug development and manufacturing. Compile and analyze experimental data to generate process knowledge and decide on next experimental steps. Write development and validation reports and ensure their timely delivery. Prepare and present project updates to global project team and to upper management. Execute client projects according to budget and timelines given to the project team.

The Associate Scientist I and Associate Scientist II conducts pre-designed assays, make scientific observations, maintain detailed workbooks and ensure all documentation fulfills generally accepted professional/industry standards. The Rockville, MD location performs a wide variety of assays or tests required to characterize product or material safety.

Protein Sciences in our research division in Boston is seeking a Scientist-level associate to help develop and execute high-throughput molecular biology methods to support a largely automated antibody and protein production platform. This Scientist will apply an industrialized approach towards generating clone content for exploring antibody and protein diversity. S/he will be responsible for executing a centralized workflow that includes high-throughput cloning, DNA purification and DNA sequence analysis along with the associated data management. These efforts will be a complement and central resource to existing capabilities and will serve as a means to expand the ability to interrogate antibody/protein diversity in order to identify optimal leads.

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

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

The Product Support Specialist's role is to be an expert in the functioning and application of Magellan Diagnostics' products and to participate in the team that provides technical product support as well as product training to external and internal customers, including nurses, doctors, and laboratory technicians as well as sales, marketing and other personnel. This team is also responsible for laboratory investigations required to assess and understand customer complaints, for tracking and closing complaint investigations, and for working with Quality Assurance to properly escalate complaints in the quality management system. This individual must have knowledge of specific laboratory techniques and instruments and must be able to recognize factors that directly affect procedures and results. The Specialists are also called upon to report lab results internally, maintain equipment, and maintain laboratory records, as well as to use the company's CRM system to document customer interactions. The job requires patience, precision and the ability to work well under pressure. The Support Specialist understands lab licensing and CLIA regulations, as well as regulatory requirements (ISO, FDA). The Specialist should have excellent telephone communication skills and the ability to work independently as well as in a team. Specialist should have excellent telephone communication skills and the ability to work independently as well as in a team.\

The incumbent is responsible for the testing of food samples using various microbiological analyses. Job responsibilities include: Follow appropriate methods and SOPS when conducting sample preparation. Maintain quality control records. Maintain knowledge of Laboratory Information Management System (LIMS) that is required to complete job responsibilities. Pipette sample solution into tubes or plates according to the analysis process being performed. Pour the agar into plates or tubes to begin the growth process. Perform confirmation tests on suspect plates or tubes to identify the strain of bacteria.

Performs routine and complex technical work such as the design, manufacture and operation of structures, machines and systems under broad supervision and guidelines. Essential duties include: Independently evaluates, selects, and applies standard technical techniques, procedures, and criteria, using judgement in making minor adaptations and modifications. Investigates a moderate number of technical variables in completing assignments that have clear and defined objectives. Performs work which involves conventional types of plans, investigations, surveys, structures, or equipment with relatively few complex features for which there are precedents.

Our Manufacturing Lab Engineer performs testing on equipment and parts in a manufacturing lab environment. Performs routine technical work such as the design, manufacture and operation of structures, machines and systems under general supervision and guidelines. Prepares and tests specimens, adjusts and operates equipment, and records test data, pointing out deviations resulting from equipment malfunction or observational errors. Performs routine technical work requiring the application of standard techniques, procedures, and criteria in carrying out engineering tasks.

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. Support preparation and coordination of submissions in accordance with the current regulations and guidance’s. Ensure submissions support company objectives and strategy. Identify and communicate regulatory risks and project issues. Make recommendations to team and regulatory management.

We are seeking a Quality Assurance Associate to work closely with the MethodSense Executive Team and Project Managers to assist with the maintenance of client’s Quality Management Systems, supporting client Regulatory solutions, and the implementation and maintenance of client technology solutions on a contract basis.

This opportunity, you will report to the Director of R&D and work with the Research and Product Development teams to both support existing applications and assist in the development of new applications in diagnostic, therapeutic, and research markets. Duties include processing clinical samples, including blood and blood products, employing safe, accurate, and repeatable methods, gathering data and information to identify best methods, materials, and technologies for cell and molecular assays, etc.

(Two openings)These positions are responsible for basic and routine tasks involved in the manufacture and assembly of the company's disposable test cartridges. Responsibilities include: 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, Maintains records and documentation associated with producing cartridges in compliance with GMP and SOPs

Duties and functions include: Improve, sustain, develop, and support of new and existing manufacturing processes for new and existing products, product changes and enhancements, as well as related tooling and fixtures. Investigation and testing of product processes. Manages builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning

This is a laboratory position in the API R&D organization. The primary activities for this position will involve assisting with the development of analytical methods, performing sample testing during R&D, and then transferring the newly developed methods to Quality Control for manufacturing. Essential job functions include assisting with the development of test methods for R&D products/intermediates/materials, perform lab testing as needed (HPLC, GC, DSC, TGA, etc.), and to report data/analysis in timely manner.

In this role you will manufacture or evaluate products according to established protocols, provide technical support to others and perform operations in support of the group and department. Essential job functions include performing safty operations, ensuring quality, performing routine assays, processes and/or unit operations, ensure proper documentation, and participate in quality audits. This job is a 24/7, 2.2.3.2 Rotating 12 hour shift 6:00 PM- 6:30 AM - 3 day weekend, every other weekend.

As a member of the Lentigen Technology team, you will have the opportunity to support the Quality Assurance systems by means of creating, tracking, and maintaining high quality technical documentation. Furthermore, you will be responsible for ensuring records are organized and maintained, and support the implementation of quality systems in compliance with GMP regulations and company policies. Overall, your keen ability to support the maintenance of quality systems and processes will help power Lentigen Technology’s continued success.

As a member of the Lentigen Technology team, you will have the opportunity to support the Quality Assurance systems by means of creating, tracking, and maintaining high quality technical documentation. Furthermore, you will be responsible for ensuring records are organized and maintained, and support the implementation of quality systems in compliance with GMP regulations and company policies. Overall, your keen ability to support the maintenance of quality systems and processes will help power Lentigen Technology’s continued success.

Responsibilities as a compounding technician include: Mixing chemicals/ingredients and operating all mixing related equipment in a way that meets safety, quality/compliance and productivity objectives. Following and enforcing safety rules, regulations and procedures. Checking all raw materials against MBR ingredients list, recognizes errors and notifies lead personnel as required. Compound/blend all routine formulations and follow MBR as written.

This position is seeking a contract Research Associate/Sr. Research Associate who will be responsible for preparation and characterization of mRNA formulations within a dynamic and highly interdisciplinary environment. Understanding of nanoparticle preparation techniques and biophysical / chemical characterization is essential for this position.  Experience with nucleic acid delivery systems is a plus. He/she will be responsible for executing lab experiments, reporting results, performing stability assessments, maintaining a high-quality lab notebook and working within a larger team of formulation scientists and associates.  The successful candidate must have a foundation in pharmaceutical sciences and materials science/engineering. 

The Research Associate will work closely with the Delivery Innovation and Production Science and Technology (PS&T) teams to manufacture lipid nanoparticles (LNPs). Novel LNPs will be manufactured in a high-throughput manner and screened for lead candidates to advance.  The Research Associate will have a unique opportunity to work in both a research and production environment, utilizing state-of-the-art automation to enable manufacture. 

Moderna is seeking a Quality Control Associate I/II for a position based at their Norwood, MA site.  The individual in this role will provide routine laboratory support for bioassay testing of mRNA material that is manufactured in the Preclinical manufacturing suite.  The successful candidate must demonstrate the ability to quickly master new techniques and the drive to be a part of a dynamic, fast paced, and highly motivated team.  He/she will participate in troubleshooting assays and equipment and may support QC related investigations. 

Moderna is seeking an Associate Engineer for a position based in Norwood, MA. The individual in this role will provide support for automated processes in Preclinical Manufacturing. The individual will work with method developers, scientists, and operators to ensure instruments are functioning to manufacturer’s specifications. The ideal candidate must have at least 2 years of experience in the industry, specifically working with integrated systems, custom automation/skids, Hamilton liquid handlers, and chromatography solutions.

 The candidate will collaborate cross-functionally with the immunology, fibrosis, and oncology groups. The candidate is expected to be able to multi-task and pay attention to detail. Strong experimental and technical research skills as well as excellent communication skills are required. Creative problem solving will be an integral part of the job. 

The QC Technician is responsible for a wide variety of routine tasks in the Quality Control Department. These include: RIA and EIA bench top assay work. Inspection of incoming raw materials. Refrigerator and freezer temperature monitoring. QC document copying, collating, and filing.

As a chemist one will be responsible for performing pharmaceutical testing (HPLC, GC, TLC, UV, IR Spectroscopy, etc), develop/validate analytical test methods for pharmaceutical products, and write technical analytical reports.

Essential duties and responsibilities include: Prepare isolated adult animal cardiomyocytes for contractility assays, Use pre-established experimental designs to plan, and execute myocyte contractility and Ca2+ transient assays, Propose solutions to technical issues: proactively seek out senior team member to discuss potential resolutions to problems

Purification of a wide variety of cardiac muscle proteins using various chromatographic techniques; Carry out multiple experiments in parallel and keep detailed, meticulous notes; Collaborate with colleagues and team members to provide robust quality control data

The Document Control Associate, Quality Assurance will be responsible for performing Quality Assurance document control, document workflow, administrative support and other quality system activities at MyoKardia. This position will be eligible for overtime.

Triage Patient Advocate reviews all paperwork submitted with patient samples to ensure all required information for testing is received. They enter the patient’s insurance information into the database application and determine if the patient’s insurance requires additional documentation/processing for testing to be covered. The ability to focus on quality is crucial in this role. The candidate must be very detail oriented as well as be able to determine how small details will affect case completeness as a whole.

The Automation Engineer I is responsible for maintaining existing Manufacturing systems as required. Additional duties include the development of new methods and implementation of new systems. The ideal candidate has knowledge of FDA and ISO requirements as they apply to manufacturing processes.The Automation Engineer I is responsible for maintaining existing Manufacturing systems as required. Additional duties include the development of new methods and implementation of new systems. The ideal candidate has knowledge of FDA and ISO requirements as they apply to manufacturing processes.The Automation Engineer I is responsible for maintaining existing Manufacturing systems as required. Additional duties include the development of new methods and implementation of new systems. The ideal candidate has knowledge of FDA and ISO requirements as they apply to manufacturing processes.

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.

Natera is currently seeking a Clinical Laboratory Associate I (Temporary) to analyze laboratory specimens following the standard methods and procedures while maintaining equipment and instruments in good operating condition by troubleshooting malfunctions as needed. Primary responsibilities include: Assists in testing of patient samples according to standard operating procedure in an efficient manner with little to no errors, Responsible for maintaining updated understanding and knowledge of methods performed in the lab, Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.

The Laboratory Technician will join the QC Equipment team in the Operations department to support the equipment used in the clinical laboratories. Responsibilities will include activities related to maintenance of accessory equipment used in the Operations lab.

The Research Scientist is responsible for independently evaluating, selecting, and applying standardized scientific or engineering procedures and techniques.  They work with a project team to determine the experiments, testing, and/or modeling necessary to achieve project objectives.   

Natus is seeking a Product Implementation Engineer for our Midwest region. This position is responsible for working with customers on Neuro product line site-specific server planning for SQL, Citrix, and HL7; server implementations, and post-installation support.  The qualified individual will provide input to product development teams on such products and train technical support as required to support such products and may be called on to visit customer sites for the installation, in-service, and repair of the company's supplied equipment.

We are seeking highly motivated, energetic and committed individuals to join our interdisciplinary team and actively contribute to advancing our drug discovery programs from discovery to proof- of-concept. You will build your experience in early discovery projects using cell-based and biochemical/biophysical approaches to support small-molecule discovery activities and advance our cutting-edge programs that target the mTORC1 pathway.

Operates production equipment. Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities. May help in validating processes and equipment that are directly related to filtration, cleaning and sterilization. Maintains records and clean room environment to comply with regulatory requirements, good manufacturing practices and standard operating procedures. Works on projects that are moderately complex in nature. Exercises judgment in resolving problems and making some routine recommendations. Provide Lab Support for manufacturing suites. Learn how to run equipment, read and understand SOPs. Support processing by adhering to SOPs. Follow HazMat procedures, for movement of Raw Material used in chemical processes. Support investigations
Review SOPs. Troubleshoot and offer ideas on improvements. Interact with other departments to share information. Performs other duties as assigned.

The Chemist I provides daily operation to established methods, ensuring quality compliance to the protocol. They have overall responsibility for the technical conduct of all assigned tests as well as for the analysis, documentation, and reporting of results. They are the single point of study control. They communicate with clients on technical aspects of the testing. They serve as a master trainer in the company.  

Join our team in Salt Lake City, UT to build custom transgenic C. elegans strains for clients around the world. Enjoy the challenge of applying cutting edge genome engineering techniques to create new research tools in a timely manner. The sophisticated nature of the work requires attention to detail and high-functioning knowledge of current genetic techniques. You will use your creativity and problem solving to troubleshoot projects and identify new solutions. The ability to work independently according to schedule is balanced with the need to collaborate extensively with teammates to ensure that we consistently meet or exceed our clients’ expectations.

In this position, you will need to analyze specimens and review and release test results. You will have the means to prepare stock solutions, reagents and cocktails used in the laboratory. You will then test these based on standard criteria and document all observations. You will be responsible for performing highly complex laboratory testing procedures. You will figure out acceptability of specimens for testing, prepare clinical specimens and identify specimen related problems.

The Diagnostic Production Department for Neogen Corporation is seeking candidates for a technician position responsible for manufacturing, packaging, and assembly of diagnostic test kit components. The ideal candidate will be reliable, possess attention to detail, and able to work in a fast-paced environment. Responsibilities include: Sets up, adjusts, and operates laboratory equipment and instruments including, but not limited to: balances, microplate dispensing equipment, reagent dispensing equipment, bottle cap tightener, and labeling equipment. Cleans and maintains work areas and equipment used in daily manufacturing duties. Produces and packages plates approved by QC Department.

The Food Safety Division is currently seeking a candidate for a Lateral Flow Chemist position. The selected candidate would be responsible for formulating reagents and preparation of some components used in the assembly of Diagnostics and Dairy Antibiotics Lateral Flow products. Other duties would include testing and documenting results following ISO and GMP procedures. The ideal candidate should have the ability to perform basic mathematical operations, follow and document all manufacturing procedures, be capable of identifying and resolving problems in a timely manner and be able to work both independently, as well in a group setting. The selected candidate will be responsible for preparing buffers, solutions, and reagents according to Standard Manufacturing Procedures (SMP’s) and Work Orders, while maintaining an accurate inventory of chemicals and supplies.

Neogen’s analytical laboratory has an opening for an associate research scientist. The position requires a B.S. in Chemistry or Natural Sciences with a Chem. minor and >1 year of direct experience performing HPLC. Candidates should have experience with the detection of analytes in food matrices using solid phase extraction or immunoaffinity columns. Experience with other spectroscopic methods including IR, NMR, and NIR are desirable. The primary task in this role will be to assist with daily operations of the analytical lab. These operations include sample analysis using standard methods, compiling and reporting data, accurate documentation, and maintaining equipment. Additional duties include implementation of continuous improvement goals and the development of new assays. The ideal candidate will work well in a fast paced, cooperative environment to ensure that samples are analyzed quickly, accurately, and that results are reported in a timely fashion.

The Food Safety Division is currently seeking a candidate for a Lateral Flow Chemist position. The selected candidate would be responsible for formulating reagents and preparation of some components used in the assembly of Diagnostics and Dairy Antibiotics Lateral Flow products. Other duties would include testing and documenting results following ISO and GMP procedures. The ideal candidate should have the ability to perform basic mathematical operations, follow and document all manufacturing procedures, be capable of identifying and resolving problems in a timely manner and be able to work both independently, as well in a group setting. The selected candidate will be responsible for preparing buffers, solutions, and reagents according to Standard Manufacturing Procedures (SMP’s) and Work Orders, while maintaining an accurate inventory of chemicals and supplies. Responsibilities also include maintaining the general cleanliness and organization in area of physical responsibility and assisting in troubleshooting and validation procedures.

The Food Safety Division is currently seeking a candidate for a Lateral Flow Chemist position. The selected candidate would be responsible for formulating reagents and preparation of some components used in the assembly of Diagnostics and Dairy Antibiotics Lateral Flow products. Other duties would include testing and documenting results following ISO and GMP procedures. The ideal candidate should have the ability to perform basic mathematical operations, follow and document all manufacturing procedures, be capable of identifying and resolving problems in a timely manner and be able to work both independently, as well in a group setting. The selected candidate will be responsible for preparing buffers, solutions, and reagents according to Standard Manufacturing Procedures (SMP’s) and Work Orders, while maintaining an accurate inventory of chemicals and supplies. Responsibilities also include maintaining the general cleanliness and organization in area of physical responsibility and assisting in troubleshooting and validation procedures.

Perform microbiology department related tests according to USP methods and established procedures that follow cGMP guidelines and demonstrate outstanding aseptic techniques. Apply quality scientific techniques in the microbiological analysis of raw materials; in-process & finished product samples to include: sterility, bioburden, identification, environmental monitoring, growth promotion, microbial recovery and media fill tests following approved procedures. Demonstrate ability to understand and interpret test results in relation to acceptance or rejection of lot tested. Report, initiate documentation and assist in excursions and investigations of OOS and OOT reports.

Under general guidance from the Director of Clinical Operations and the Clinical Trial Manager, this individual will support the Clinical team responsible for management of multiple clinical trials (all phases), and assure compliance with GCP and ICH guidelines. 

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. Responsibilities includes: 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. Support departmental responsibilities associated with training and qualifying manufacturing assemblers.

We are looking for a highly motivated and creative Research Associate to join our drug discovery team. The primary responsibilities will include an emphasis on novel target discovery and validation using cell-based in vitro assays. Additionally, the new team member should be motivated to learn and execute a wide range of techniques such as the isolation and purification of primary cells, protein target expression analysis using flow cytometry, multiplex immunoassays, and other biochemical and molecular biology techniques. The ideal candidate will be a self-motivated team player, with a high-level of scientific curiosity and enthusiasm for novel biological discovery.

Executes experimentation for the development of synthesis, purification and lyophilization processes to scale-up, optimize and validate processes. Maintains up-to-date knowledge of Avecia oligonucleotide manufacturing processes. Advises supervisor as to the status of assigned activities. Normally receives general instruction on routine work and detailed instructions on new assignments.

Job duties and 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.

Job duties and responsibilities include: Electrical and mechanical aptitude with the ability to design, fabricate and wire electrical control panels and test fixtures. Write comprehensive documentation on tester hardware and software designs. Provide troubleshooting support to engineering and assembly teams on products and processes

Responsible for designing, defining, implementing system requirements, analyzing and/or testing Asymtek products. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.  Receives specific and detailed instructions as to required activities and expected results.  Performs a variety of routine tasks, which should provide experience and familiarization with the engineering staff, methods, practices and programs of the company.

Duties and functions include: Performs routine testing to assess the conformance of raw materials, finished products, and/or stability samples to predetermined product specifications. Performs routine testing in conformance with approved procedures, accurately and concisely documents data, and reports results. Demonstrates a basic knowledge of SOP’s and GMP regulations as related to the pharmaceutical quality control laboratory.

Nova Biomedical is looking for a Technical Product Specialist to join our Product Support department in Waltham, MA. In this highly visible, diverse role, you will serve as the primary point-of-contact for customers using Nova Biomedical’s instrumentation. This is a terrific opportunity for a medical technologist or a science graduate who is looking to start a career in a customer facing role and grow with a medical device company.

To support release product that meets required quality and manufactured standards to affiliates and the public.

The successful candidate to this position will support design, execution and interpretation of biochemical/cellular assays to enable the discovery and pharmacological characterization of novel anti-parasitic drugs such as malaria, trypanosomiasis and cryptosporidiosis. 

Performing Bioanalytical testing in support of clinical and commercial release strategies.

We are seeking a highly detail-oriented and organized individual to support Process Development with the manufacture of buffers and media. Additionally, this individual would be responsible for managing the PD inventory program. Main function will be to perform the day to day activities in the Solutions Preparation Area: preparation of buffers, preparation of cell culture media/feeds, calibration of pH and conductivity meters/probes, transport of glassware, scheduling equipment maintenance, etc., to support all of process development.

The qualified individual will apply US FDA, international GMP regulations, guidance documents, and industry best practices in the development and execution of validation protocols. The role will support the validation activities within the following areas: bioprocessing, analytical, controlled temperature units, facilities, utilities, and cleaning.

Qualified individuals will be responsible for performing all microbiology assays.

Key areas of accountability include the direct support of in vitro pharmacology, cell signaling, electrophysiology, metabolic phenotyping and exploratory safety studies at NNRCSI. Day to day activities include working with the In Vitro Biology staff to plan, schedule, and execute discovery related studies, manage data collection, organization and summarization for stakeholders.

This position carries out routine microbiological testing to support the manufacturing facility. All work is carried out in a QC GMP environment where the highest level of compliance and attention to detail is necessary. Role focuses on routine activities such as utility and facility monitoring, data reporting, general laboratory support and activity coordination. 

Candidate will be responsible for development and optimization of tissue-based assays. Individuals will have a background in biology or a related discipline and laboratory experience in human and animal tissue preparation, histological staining, and immunohistochemistry (IHC). Individuals must be self-motivated and detail-oriented, exhibit excellent organizational and communication skills, as well as demonstrate the ability to work under defined timeframe, thrive with a high degree of independence and be a team-player.

The researcher will support projects designed to improve enzymes for industrial applications. The successful candidate will assist with the generation of these enzyme variant libraries and be involved in screening those libraries to identify improved enzymes in our high throughput automation laboratory. This is a two year position.

The entry level Research Technician will be responsible for supporting study progression according to study protocol and Standard Operating Procedures.  Responsible for obtaining vital signs, performing EKGs, and drug/pregnancy testing from study participants as required by the protocol.  Observes, obtains and processes all laboratory specimens. Performs service oriented duties along with stocking supplies and general support to all phases of screening process.

The Clinic Quality Control Associate is responsible for performing day-to-day quality control activities to ensure study compliance meets company, client, and regulatory agency requirements. These activities include transcription and proofreading, identifying errors, developing corrective actions and tracking/trending processes for improvement under management direction.  Will also observe and audit study activities to ensure compliance with Standard Operating Procedures and study protocols; report/present findings to study management.  At the discretion of management, will recall and audit past study files for quality assessment.

As the Validation Engineer, you will ensure the quality of the medical device software and hardware meets the design requirements and that they are testable. You will also develop, implement and maintain test plans, protocols, test scripts and traceability matrix for design verification & validation. Essential responsibilities include: Execute protocols/test scripts and document results. Generate and/or update summary reports. Ensure compliance with FDA device regulatory requirements, including DHF and 510(k). Communicate with Hardware and Software Development, Marketing, Technical Services, and other project team members to ensure schedules and requirements are consistent with project expectations. etc.

As the manufacturing engineer, candidate will be responsible for: Coordinate cross-functional teams to execute and document the manufacturing launch of new/legacy products. Determine manufacturing processes required to accurately and efficiently make spinal implants, from raw material to final cleaning and shipment. Develop and complete manufacturing documentation (pFMEA, control plan, process flow, work instructions, and inspection plans). Perform research, design, and development of manufacturing processes including production flow, assembly methods, and production equipment. Perform product/process analysis and troubleshooting for cost reduction, quality improvement, and improved efficiency. Design, develop, test, source, and cost-justify various tools, machinery, and equipment for recommended manufacturing methods.

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

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

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

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

The position of Regulatory Affairs Associate will be responsible to provide immediate administrative regulatory support to ensure timely introduction of advertising and promotion content in the U.S, as well as opportunity in the future to support new products subject to medical device regulations in both the U.S. and global regions. Provide regulatory support to marketed products and ensure company’s regulatory compliance status. Responsibilities include: Manage regulatory databases and administer regulatory processes, primarily advertising and promotional content, which includes activities such as data management and verification, Support the development and implementation of regulatory processes, procedures, and standards as assigned.

Oncotherapy Solutions LLC is seeking a highly motivated and creative research associate to characterize and test drug conjugates in-vitro as well as analyze tissue and blood samples from outsourced in-vivo studies. Responsibilities include: Perform solubility and in-vitro stability assays as well as formulation of drug conjugates. Conduct viability and apoptosis in-vitro assays using cancer cell lines, normal cells and immortalized non-tumorigenic cell lines. Extract and purify nucleic acids and proteins from cells, tumor and normal tissues as well as perform RT-PCR, PAGE, western blotting and ELIZA.

OPKO Diagnostics is seeking a highly motivated Research Associate with a Bachelor's degree in Chemistry or Biochemistry and/or prior hands-on experience in bioconjugation and purification to join our research group in Woburn, Massachusetts. As a member of the R&D group, you will be working closely with in-house expert in conjugation chemistry and contribute to the development of innovative diagnostics tests on the Claros Analyzer platform. Responsibilities include: Plan, perform and document protein modification and bioconjugation experiments. Prepare, purify (e.g. HPLC, continuous gel electrophoresis) and analyze (Native and SDS PAGE) protein and antibody conjugates. Conduct experiments to improve efficiency and scalability of conjugates to support routine manufacturing.

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. Follows established company rules, regulations and safety precautions, and maintains quality standards.

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

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

The primary purpose of this position is to issue batch production records and product labels to manufacturing in a timely manner to meet the production schedule. Principle responsibilities include: Assignment of product lot numbers and issuance and inspection of batch records associated with each manufacturing process. Generation and inspection of complex product labelling for all products in current production, including the ability to identify minute defects on printed labels. Coordinating printing schedule based on production plan to ensure manufacturing operations are not halted through lack of batch records or product labels. Maintaining controlled area inventory, packing and verifying quality records to be sent to off-site storage.

This candidate will perform testing as part of a product development team that deals with food safety. Responsibilities include: Perform allergen identification and measurement by ELISA and Lateral Flow Devices. Perform a wide range of general microbiology testing to include: particulate analysis, sterility testing, and microbial identification. Conduct analysis of products using traditional microbiological techniques such as serial dilution, pour plating, and filtration. Participate in general laboratory cleaning and maintenance.

Candidate will perform analytical testing to support product development on inhalation devices. This is a high volume, fast-paced lab. Analytical lab experience is necessary, but fresh grads will be considered. Complete non-chromatographic tests such as: drug content, drug impurities, water content, dose content uniformity (DCU), through life testing, next generation impactor (NGI), particle size, spray pattern, microscopic appearance in support of stability, and other studies for development of an inhalation product

Entry level position in laboratory services where work is closely supervised and done in accordance with well-defined standards and procedures of an uncomplicated nature. Responsibilities include: Analyzing or preparing samples in an efficient and organized manner, using approved Pace Analytical procedures. Preparing reagents and standards. Waste handling duties to include: labeling containers, understanding storage time limits, performing proper satellite accumulation, ensuring adequate space between waste containers, ensuring all waste containers are closed and incompatible materials are stored separately, understanding secondary containment, and documenting weekly inspections, if applicable.

The purpose of this position is to carry out assigned laboratory duties which may include sampling, testing, and evaluating analytical data on samples such as raw materials, in-process and final products. Other responsibilities include: Maintain organized records of tests performed and results obtained. This may include maintaining a computer accessible database for the purpose of tracking and trending analytical data. Conduct laboratory tests in compliance with established internal Standard Test Methods, compendial methods and vendor partners supplied methods. Assist in the development and improvement of written procedures.

The purpose of the position is to provide technical expertise in the area of pharmaceutical microbiology. The position functions in a cooperative effort to provide quality control and assurance to the operational departments involved in the manufacture of pharmaceutical products. Conduct routine environmental and systems monitoring of manufacturing and laboratory areas. Conduct general laboratory experimentation in compliance with the instructions provided in approved SOP’s to determine appropriate action. Follow policies and assists in the development of new procedures and/or documents. Maintain records of experiments performed and results obtained including appropriate calculations. Assist in the interpretation of data as require and conduct accurate and precise experimentation and complete documentation of results. Assist in the preparation of data for presentations. Maintain a level of technical knowledge and understanding in the assigned areas of responsibility consistent with the scientific requirements of the company. The qualified candidate will possess the following: 0 years of relevant experience in pharmaceutical microbiology. BS degree in Microbiology or other life science from an accredited college or university or equivalent experience. Proficient in the use of computer word processing, spreadsheet management, and data graphics programs. Ability to qualify Class 100 gowning and maintain a qualified status. Ability to manage multiple responsibilities with a high degree of self motivation. Good oral, written, and interpersonal English communication skills. Ability to read and accurately follow the instructions of standard operating procedures. Ability to effectively utilize scientific information resources

The Protein Sciences group at PACT is looking for a motivated and talented Research Associates at various levels. The individual will be responsible for the execution of high-throughput cloning, protein expression and purification and will be involved in the critical path for the discovery of neoEpitope and corresponding cognate TCRs. The position involves a considerable amount of bench work and will focus on molecular cloning, cell culture and protein purification using state-of-the-art automated liquid handler and chromatography systems. The ideal candidate should have highly analytical skills and keen attention to details and should enjoy operating in an exceptionally dynamic and collaborative environment. Requirements: The ideal candidate should hold a bachelor’s degree with 2-4+ years of experience or master’s degree in Protein Biochemistry, Molecular Biology or related disciplines with 0-2+ years of experience Prior experience with mammalian cell culture and with recombinant protein expression Experience with cloning, sub-cloning and DNA purification; Sequencing is a plus Acute attention to details, well-organized, diligent with documentation and self-motivated Highly goal-driven and the displays the ability to handle delicate experiments in a timely manner Able to operate in a collaborative environment and communicate clearly and concisely, both verbally and in the form of written reports Some experience with protein characterization as SDS-PAGE, Western blot, FPLC, HPLC, SPR, DSF, etc. Responsibilities: Produce a wide variety of recombinant DNA clones Expression and purification of recombinant proteins in high-throughput in a mammalian host system Optimize expression systems and purification protocols to maximize protein production output Coordinate activities with functional groups and project teams Update electronic lab notebook entries and inventory Perform QC and characterization of proteins

Responsibilities include: Developand performin vitro/ex vivo human and murine primary cell-based assays. In vivo pharmacology including test article dosing, blood collection and tissue harvesting. mmune cell isolation from whole blood and tissues, flow cytometry, cell sorting,ELISA/MSD/HTRF.

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. Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams. Participates in reviews and structured processes for continuous improvement.

The Manufacturing Associate performs and documents cGMP activities to support upstream or downstream production areas and operations. This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed.

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 assay development strategy and aids in the transfer of the assays to the Manufacturing department for final commercialization. The R&D Scientist is also responsible for development of custom assays and reagents for clients. Essential Duties and Responsibilities: Develops immunoassays and cell-based assays for commercial markets Optimizes and verifies assay performance in multiple biological matrices from normal and diseased organisms Ensures robustness and ruggedness of assay performance to facilitate ease of large-scale manufacture Develops and screens new tools and reagents, such as by purification of antibodies, for assay suitability Develops and verifies new assay technologies Assists in the transfer and troubleshooting of assays developed within PRaDAS to the Manufacturing department Performs additional duties and/or other projects as required or assigned Supervisory Responsibilities: None Requirements: B.S. degree in biological sciences; advanced degree acceptable 1+ years of ELISA or other immunoassay development experience Experience with multiple immunoassay and cell-based assay formats preferred Ability to execute pipeline projects and effectively interpret, summarize, and report data to R&D management Strong work ethic, positive attitude, and the ability to work independently Excellent written and verbal communication, interpersonal, and presentation skills necessary Must be highly attentive to detail and well organized High level of proficiency in Microsoft Office Suite and GraphPad Prism Physical Demands: Standard Office/Lab work demands No heavy lifting or carrying required Work Environment: Office/Lab environment Will be notified of any potential harmful exposure

This position is an invaluable opportunity to gain experience working withcutting edge technology and a variety of cell types that are significant to the rapidly emerging cell and gene therapy market. Responsibilities and tasks: Participate in research efforts for various cell culture processesbased on client needs. Prepare scientific data for external publications, abstracts, and presentations, including those atinternational conferences andtrade shows. Supportroot-cause analysis forunexpected results and provide new approachesor experimental strategiesfor problem solving

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

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

As an Engineer I at Penumbra, you will work with engineers in the Manufacturing, Research and Development, or Quality groups to support the development and testing of new products; the development and improvement of manufacturing processes; and compliance with Penumbra’s Quality System and all applicable regulations and standards. What You'll Work On Under direct supervision, you will be assigned to assist with any of the following: Conceptualizing and prototyping of new product concepts. Documenting design and process steps. Creation of test protocols and reports. Testing and documenting results. Development of processes and fixtures to improve ergonomics, throughput, and/or yield in manufacturing. Preventative maintenance of equipment. Creation and maintenance of product and process documentation. Development of testing and inspection methodology. Design of QC process sampling systems and procedures. What You Bring The desire to hone your engineering skills in a dynamic, fast-paced work environment. A Bachelor’s or Master's degree in an engineering or scientific discipline. Experience in a manufacturing or laboratory environment strongly preferred. Strong written and oral communication skills. Proficiency in office software applications. Highly developed interpersonal and teamwork skills. What We Offer A collaborative teamwork environment where learning is constant and performance is rewarded. The opportunity to be at the forefront of technology that is revolutionizing the treatment of some of the world's most devastating diseases. Depending on department needs, the Engineer I may be a contract position with the possibility of conversion to a regular full-time role. If and when a regular full-time position is offered, it will include a generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.

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.  These documents are used by our life science customers to demonstrate compliance with USFDA regulations (or other regulatory bodies) for current Good Manufacturing Practices.

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

The incumbent performs a variety of standard analyses on raw material, in-process, and finished product samples using chemical analysis techniques, according to compendia (i.e. USP, FCC, or AOAC) or Perrigo methodologies. Performs routine analyses of raw material and finished product samples as assigned, demonstrates proficiency in 5 – 10 separate Analytical Methods (AM’s). Analytical instrumentation used in this group is primarily NMR Fat Analyzer, Nitrogen Analyzer, NIR Spectroscopy, and HPLC (High Pressure Liquid Chromatography). Responsibilities include, but are not limited to, the following: Preparation of analytical standards. Accurately identify, weigh, and dilute stock standard materials for calibration purposes Weighing of samples. Accurately identify and weigh sample materials for processing through analytical methods General sample manipulations, to include: quantitative sample dilution, addition of analytical reagents, processing of samples through incubators, shakers, centrifuges, evaporators, etc. Extraction of sample solutions, to include liquid-liquid and solid-phase techniques Quantitative transfer of sample extracts between vessels Instrument configuration and routine operation Preparation of general laboratory reagents (buffers, mobile phases, etc.) General cleaning of materials after analysis Other duties as assigned. Requirements Four-year college degree in chemistry or related science. Consideration may be given to those who hold 10 years of progressively responsible and relevant work experience. Flexibility, adaptability and versatility are required. Preferred Experience 1-2 years’ experience in an analytical chemistry laboratory is preferred. Firm understanding of cGMP and Nutritional requirements preferred Proficient with Microsoft Office; working knowledge of LIMS and SAP desired Willingness to participate in, contribute to and lead a high-performance work team Physical Requirements Ability to walk, bend, stoop, reach, lift, and carry up to 10 lbs. on a regular basis and 20 lbs. on an occasional basis. Must be able to push or pull 55 pounds or more or equivalency following written safe practice measures. Required to use hands and fingers to handle; feel or operate objects. Internal applicants (employees) can apply by end of day December 15, 2018 to be considered.

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

Pfenex is looking to bring on a contract Associate Scientist 1 , to join the Analytical Sciences team. As a key member of the Analytical Biochemistry Group, the Associate Scientist I ,is responsible for executing analytical and biochemical characterization activities for biotherapeutic protein product development, including assay development, assay qualification, and product characterization. This position must effectively communicate timelines and issues to ensure successful manufacturing, product testing/release and data package for regulatory filings. Individual technical issue management and cross functional communication are key position attributes. The candidate will work in a team environment, collaborating with various departments to ensure that manufacturing processes are properly characterized to support process transfer, achieve project goals, and timelines.

POSITION SUMMARY Reporting directly to the Manager, Lab Operations the Technician, Buffer/Media & Lab Support will provide media preparation services, equipment management, and general lab support for the Research and Development team. Primary areas of responsibility include but are not limited to preparation of buffers and reagents to support small and large-scale protein purification as well as coordinating and organizing required services for laboratory equipment.The Technician, Buffer/Media & Lab Support will also provide support in the preparation of reagents and solutions for the analytical biochemistry group and media preparation for the upstream processing group. They will additionally provide general lab operations assistance related to supplies, equipment, and safety.

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.

To help design analysis data set specifications. Manage and manipulate multiple large SAS data sets, including defining populations and variables, performing calculations and summarizations. Prepare specific analytic deliverables, combining multiple programming outputs to create cohesive reports. Key responsibilities include: Responsible for creating specifications for generation of analysis datasets per ADaM/Pharm-Olam/Sponsor requirements, or as mentioned in SAP. Ensure SAS programs adhere to specifications/Mock Shells and Pharm-Olam programming standards. Responsible for writing programming in order to generate tables and listings for clinical data on assigned projects for Production/Validation as assigned by Line Manager.

The position requires the analyst participation in all High Throughput Clinical Testing (HTCT) activities including but not limited to assay development, clinical testing of vaccine trials, robotic and manual preparation of samples and reagents for preclinical and clinical serology, and biofunctional assays. The position also requires all work to be done in a compliant manner according to SOP(s), GLP, or GMP guidelines, as required. The job also involves performing other tasks as assigned, related to clinical Serology, functional bioassays, ELISA, and Robotics when necessary. As an integral member of this dynamic clinical testing team, the incumbent must have a strong, positive work ethic and be highly collaborative with the other group members. All of the above includes practicing laboratory safety at all times.

The Analytical Chemist III 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.

Job duties include: Responsible for the synthesis and purification of peptides under Good Manufacturing Practices (cGMP). Participates in the development and scale-up of synthesis and purification processes.

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

As 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.

Candidate will be involved in developing and maintaining a portfolio of customer-facing solutions and applications. These projects will mainly include front end web and mobile developments, backend applications, and mobile content synchronization processes. Must have experience with ASP.Net, Python, Java and Javascript.

The Clinical Research Associate will monitor the progress of linical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and the reported in accordance with the protocol, SOPs, ICH-GCP, and other regulatory requirements.

Duties include: Perform study specific clinical procedures, collect and record study data on CRF/SDs and interact with subjects during confinement and outpatient periods of clinical studies. Performs basic medical procedures according to protocol for specified study participants, include but not limited to informed consent, vital signs, Height/weight/BMI measurments, meals, water fast, phlebotomy, finger stick blood sugar, ECGS, UA, UDS, urine collection, fecal collection, pulse oximetry, AE/ConMed assessment, etc.

The Associate Scientist, Cell Therapy BioAnalytics works within the Cell Therapy Development Team and will participate in bioanalytics technology development efforts, both internally and in collaboration with industry partners, to deliver best-in-class bioanalytics methods that will drive development of the fundamental manufacturing technology platform for allogeneic T-cell therapy bioproduction. The position will contribute to bioanalytics development efforts for CARs and TCRs by providing assay development, verification, validation, and standardization. The Associate Scientist position is lab-based and will share facilities and resources with the Cell Therapy teams.

Collaborating across a broad portfolio of sophisticated health economic and health policy research projects. Performing a wide range of activities including: literature reviews; regression analysis; preparing content for reports and manuscripts, slide decks and meeting notes; quality assurance/review; and other activities.

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.

Scientific Associates develop and write medical content for assigned client account(s) and work in conjunction with all internal teams to ensure that the client vision is achieved and content is medically accurate. Responsibilities include: Developing and writing medical content for multiple and wide-ranging therapeutic areas and appropriate audiences. Ensuring project quality and outcomes by demonstrating in‑depth technical expertise of assigned therapeutic category and/or managed care areas. Developing strategic content for full range of medical content (slide presentations, advisory boards, strategy guides, monographs, discussion guides, training resources, etc.)

We seek an experienced electrical engineer with digital/analog circuit design skills to lead the electrical design of these devices. Major responsibilities include: Develop breadboard systems for testing feasibility of optical detection concepts. building miniaturized PCB’s from broad user requirements following design control by gathering and writing engineering requirements, designing the circuit, laying out the PCB, overseeing its fabrication and assembly, powering up and testing the circuit with embedded developer’s help. Interface with vendors to oversee design transfer and manufacturing scale-up. Test electrical functionality of devices

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.

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

Essential duties include: Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.). Maintains and disseminates basic study tracking information including, but not limited to: Visit Reports, Regulatory Documents, Site Contact Lists, Team Contact Lists, Vendor Lists, and Budget Disbursements. Manages and tracks Investigational Product supplies for study centers; receives and prepares requests, ships and returns Investigational Product supplies.

This individual will report to the QC Supervisor and will contribute to general operations and testing of the QC BFT lab. The QC Analyst II works independently under general supervision, but will participate with the QC team to meet group goals. Primary responsibilities include, but are not limited to, the following: collection and processing samples in a timely manner; microbiological routine testing of environmental, critical utility, in-process, validation, BDS and drug product samples in accordance with SOPs and cGMP regulations; review of laboratory assay documentation for accuracy and timeliness; evaluation of preliminary test results; aid in the development of test methods.

We are seeking a highly motivated engineer to join the Pharmaceutical Development group supporting process development for respiratory drug products. Responsibilities: Support development and optimization of engineered particle inhaled dosage forms. Specific methods may include bench and pilot-scale spray drying Support development of new technologies Perform physicochemical property and aerosol performance characterization of solid-based inhalation dosage forms Support batch manufacture for development, pre-clinical and clinical studies Skills: Strong engineering fundamentals Excellent problem solving and data analysis skills Excellent oral and written communication skills Attention to detail Fluency in MS Office software Accuracy in following instructions, generating data, and documenting data and procedures Experience with general laboratory procedures Demonstrated mechanical and/or electronics aptitude, or previous experience with pilot labs or hands-on controls engineering, is a plus Familiarity/experience with particle engineering and/or spray drying is a plus

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

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

QIAGEN is seeking candidates who will assist in the development, implementation and optimization of sequencing protocols on the sequencer, QIAGEN’s next generation massively parallel DNA sequencing platform. The successful candidate will be an integral part of the sequencing development team and will be responsible for maintenance and operation of instruments, preparation of reagents according to SOPs as well as executing complex laboratory experiments.

The Technical Associate in Kit Assembly comprehends and performs assigned manual production tasks according to established standard operating procedures. Responsible for Manual production and assembly procedures in compliance with relevant regulations and Standard Operation Procedures. Adhere to and accurately complete all production-related documentation. Responsible for set up, trouble shooting and operation of production related equipment within the assembly area.

QIAGEN is seeking candidates who will assist in the development, implementation and optimization of sequencing protocols on the sequencer, QIAGEN’s next generation massively parallel DNA sequencing platform. The successful candidate will be an integral part of the sequencing development team and will be responsible for maintenance and operation of instruments, preparation of reagents according to SOPs as well as executing complex laboratory experiments. The Research Associate will: - Execute laboratory experiments without supervision and clearly report out results in a timely manner, planning and analyzing of own lab work. - Support general laboratory maintenance and preparation of reagents and maintaining inventory of supplies. - Prepare and execute sequencing runs as required by development team schedule. - Produce and maintain proper project documentation in compliance with QIAGEN requirements independently.

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

The Packaging Operator is responsible for providing the Technical and Operational Skills needed to deliver world class results in the key areas of Line Efficiencies, Quality, and Cost while meeting our high standards of Safety, Customer Service, and Teamwork. Key responsibilities include: Operation of Packaging Line and related equipment including startup, clearing jams, manual operations and shutdown. Follows all applicable waste, scrap reduction and recycling guidelines. Assists in changeovers, wash outs and preventative maintenance.

The Research Associate is an entry-level position that is responsible for the execution and analysis of cell-based, molecular biology, and biochemical assays in support of Reata’s drug discovery and development programs. The ideal candidate will be a dynamic member of the research team who can reliably generate data using validated assays. The Research Associate is expected to work both independently and in collaboration with team members. In addition, the Research Associate must thrive in an environment that demands frequent reprioritization of projects and goals. RESPONSIBILITIES: Execute cell and molecular biology experiments to support drug discovery and development Critically analyze results and draw conclusions Actively engage in discussions of experimental strategies and results with team members Present experimental data at periodic lab meetings Read and understand scientific literature as it relates to assigned objectives Maintain detailed notebooks, project summaries, and accurate records of compound libraries Abide by all laboratory standard operating procedures and safety regulations Troubleshoot and optimize existing protocols as needed Assist with assay development, as well as preparation of manuscripts and internal reports

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

Regeneron is seeking a highly qualified candidate for a R&D Associate for infectious disease target discovery, assay development and monoclonal antibody evaluation and selection. Responsibilities include: Design, execute and control experiments based on protocols. Perform advanced laboratory calculations and manipulations along with the analysis and interpretation of data with little to no supervision. Communicates experimental results, conclusions and ideas directly to supervisor, project team members and management in quality presentation form. Develop new methods or technologies and troubleshoot protocols.