Links to 1177 Entry-Level Biotechnology & Life Science Jobs

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.

Assist in the development, optimization, and scale-up of cell- and virus/viral vector-based processes including cell banking, adherent and suspension cell culture, cell counting and metabolite analysis.

We are seeking a talented Research Associate (level determined by candidate experience), Rational Strain Engineering for our Industrial Products Division (IPD) located in South San Francisco. The candidate will have strong molecular/microbiology biology skills and familiarity with micro-cultivation of microorganisms. Appropriate candidates will have strong background in synthetic biology and microbiology and thrive in a dynamic team environment.

Execute production operations according to defined procedures and ensure the integrity and quality of our products

Typical development activities will take place in the lab, working directly with application development engineers.

The person hired for this position will be responsible for designing and writing technical documentation for products such as user manuals, repair manuals, parts lists, exploded assemblies of product, technical reference materials, technical translations, release notices and update instructions, technical publications, etc. Clearly and accurately addresses the information needs of the applicable audience, while also editing work for other writers.

The person hired for the position of Product Assurance Engineer will focus on electronic hardware products in our device reprocessing business. This position will lead and support projects that positively impact product service, performance, and quality. This individual will work closely with plant and division Manufacturing Engineers, plant manufacturing personnel, division Product Assurance personnel, and component Suppliers, and will report directly to the Device Reprocessing Hardware Quality Manager.

The Research Associate will be responsible for the execution of routine testing in support of process development and routine manufacturing, and will contribute to the development of analytical assays for characterization of therapeutic products. The successful incumbent will need to make experimental observations, review and analyze data for presentations and reports, and will share maintenance responsibilities such as reagent preparation, material ordering, and general lab upkeep.

Under the direction of the Chief Scientific Officer, you will assist in the conduct of research and preclinical studies involving adult human stem cells. This includes planning, conducting and directing a variety of experiments and assisting in daily activities for research projects.ﾠ

The Specialist, Regulatory Affairs is responsible for obtaining regulatory approvals in U.S. and ensures compliance to agency requirements including ISO, local, state and/or federal requirements

The Industrial Engineer I will support the manufacturing of products for medical devices with work including Operational systems development, process flow, Operational needs and Process efficiencies.ﾠ

The position requires being technically competent in the field of monoclonal antibody production. The individual will carry out monoclonal antibody production by hybridoma technology for our contract research projects and in-house development projects.

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

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

The GC/LC Lab Technician II will be responsible for processing batches of data compiled from the extractions of drugs of abuse in the Confirmation Laboratory.

Under close supervision, this position is responsible for a variety of manufacturing support functions involving the operation of lab equipment and conduct of procedures/tasks according to established GMP, under the direction of senior staff.

To support QC functions within our Drugs of Abuse test manufacturing facility. The position will primarily focus on incoming, in-process and final QC testing, labeling, document inspection results and enter raw material inventory data to ensure the quality and functionality of manufactured products.

Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate

Conduct and document complaint investigations on returned product per department complaint handling procedures

Performance of analytical testing on raw ingredients, packaging commodities, in-process product, finished product, and plant utilities per current methodology. This includes testing for release of product to manufacturing for further processing, filling, and finishing. This also includes planning, sampling, testing, audit of records and release of sample materials.

This position primary responsibilities are the purification and characterization of biopharmaceutical products such as monoclonal antibodies in high throughput. The ideal candidate should have direct experience with mammalian tissue culture, molecular techniques, and binding assays, such as ELISA and flow cytometry. Applicant should be able to analyze, document, and report data.

As a Laboratory Assistant, you will serve a supporting role in the R&D and production teams, maintaining lab supplies and equipment, produce reagents, and maintain a monthly cleaning/maintenance schedual.

Individual will be responsible for processing incoming and outgoing shipments to and from supplies, maintaining accurate inventory, aliquoting product into vials/kits for customer orders/stocks, and dispatching products accordingly.

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

The position is a bench chemist level position with primary duties in preparing and analyzing samples from biological matrices using LC-MS/MS as the primary analytical instrumentation.

Primary responsibilities are to perform or support testing such as microbial load estimation via MIC,MBC, disinfection studies, antimicrobial assays, etc. according to standard operating procedures. Additional responsibilities to maintain lab equipment and supplies.

As a research associate, individula will be responsible for independently designed experiments, comprised primarly of molecular techniques such as DNA cloning, plasmid DNA preparation, mammalian cell culture, transient transfection and stable cell line generation, analysis of cell surface protein expression or antibody binding by FACS, and cell-based functional assays.

The Clinical Support Specialist champions product safety through the clinical call center that provides 24/7/365 clinical support and education to internal and external customers including nights, weekends and holidays under the leadership and direction of the Sr. Manager of Global Safety.

Primarly duties as a Process Mechanic is the performance of preventive maintenance (PM) and corrective maintenance on the facility’s utility equipment. This may include plumbing, electrical work, and operation of the facility’s HVAC system. Other responsibilities include daily inspection of all utilities and equipment, stocking of spare parts, and building grounds work.

Responsible for performing various administrative tasks in support of the Quality Assurance department and its clients including but not limited to SOP review, supporting the QA Archive, Electronic Document Management System (EDMS), and GxP Training Program. Participates in independent and team projects as defined by the department manager.

The Quality Engineer 1 (QE1) is responsible for providing Quality Assurance support to product development and manufacturing to increase product quality, reliability, and process capability. Participates on teams responsible for identifying, documenting, assessing, correcting and presenting quality issues using risk analysis and root cause analysis tools. Supports quality of new products being released to the market through participation in the product development process to ensure product and process conformance to global standards (including FDA and ISO 13485).

A Research Assocaite I will be working with other researchers and computational biologists to develop/optimize PCR-based assays for transition into service lab and/or kits. Responsible for next-gen DNA sequencing library preparation and loading, reviewing and analyzing data, and execution of detailed experimental plans.

The Production Associate II position will be responsible for processing client samples using high throughput DNA sequencing technology. This role will work within a team of other Laboratory Technicians in a fast-paced, high production setting to process research and clinical diagnostic samples.

The BSM Specialist I position will join the Biological Sample Management (BSM) group at Adaptive Biotechnology’s Seattle laboratory. The primary function of this role is to support the sample management activities for the regulated laboratory that provides services for research, clinical projects, and diagnostic testing.

The Production Associate I/II/III positions will be responsible for processing client samples using high throughput DNA sequencing technology. This role will work within a team of other Laboratory Technicians in a fast-paced, high production setting to process research and clinical diagnostic samples. Candidates must have a minimum of 1 years’ experience working with human samples in a certified lab.

The QC ANALYST performs physical and chemical testing of intermediate and finished products according to written procedures.

As a QA Specialist I you will perform a wide variety of QA activities to ensure compliance with regulatory requirements and provide support to manufacturing and QC. Additional responsibilities include revewing cGMP documents, and conducting investigations related to manufacutred products and intermediate lot releases.

Participate in the development, maintenance and improvement of high sensitivity immunoassays using LSPR and/or magnetic bead and chip-based technology

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.

Required to perform processes and procedures for the manufacture of human cellular products in an aseptic cleanroom environment and in compliance with cGMP/GTP. This position is responsible for product safety and quality and has a direct impact on patient safety. Performs routine procedures following written instructions (SOPs, batch records, protocols, etc.) in support of manufacturing cell therapy product of acceptable quality in compliance with FDA and state regulatory requirements including but not limited to human tissue processing, cell expansion, cell feeding, counting, cryopreservation, harvesting and product seeding.

This is an opportunity for a Contract Development Associate I to join the Upstream Process Development group.  The primary responsibility of this position 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.

Agios Pharmaceuticals is searching for a dynamic Research Assistant to join our growing chemistry team. We are seeking a highly motivated candidate with demonstrated ability to learn new skills. The Research Assistant will be responsible for a variety of tasks that enable the daily operation of the chemistry lab. Some of the key tasks include compound purification (HPLC, MPLC), maintenance of the chemical reagent inventory and lab instrumentation, and procurement of commercial compounds for biochemical and biological testing.

The Drug Product Manufacturing Assistant is responsible for implementation of routine production and manufacturing procedures to optimize processes and regulatory requirements.

Althea is currently seeking a Drug Substance Manufacturing Associate II – Downstream responsible executing the day to day responsibilities related to the Drug Substance Manufacturing Downstream group under the guidance of Althea's established procedures and policies. The position works under the guidance of experienced team members in support of the technical transfer and integration of processes into the Drug Substance Manufacturing Downstream department. The position will be exposed to chromatography and TFF (UF/DF) systems employed during manufacturing campaigns.

The Environmental Monitoring Assistant is responsible for supporting manufacturing at Ajinomoto Althea, Inc through performing routine, process specific, and event response environmental monitoring. The Environmental Monitoring Assistant will require an understanding of aseptic technique, continuously exhibit proper clean room behavior, and adhere to cGMPs.

Althea is currently seeking a Sr. Quality Control Assistant - Chemistry, to be responsible for conducting routine analysis of raw materials, in process and final product under moderate supervision. The Sr. QC Assistant - Chemistry may focus in a specialized area and provide routine analysis and testing according to standard operating procedures in any of the following areas: in process and finished formulations, cleaning samples, and perform qualifications and transfers of methods.

Althea is currently seeking a Facilities Engineer I to provide engineering support to facility and utility systems supporting biopharmaceutical manufacturing, including aseptic filling operations. The Facilities Engineer I diagnoses and repairs facility and utility systems, and completes GMP-related documentation including corrective and/or preventive actions, change controls, deviations, and address of audit observations. This position is also responsible for maintaining a safe work environment in compliance with OSHA and other local, state, and federal regulatory agencies.

This position is responsible for implementation of routine production and manufacturing procedures to optimize processes and regulatory requirements.

The Drug Product Formulations Manufacturing Assistant is responsible for execution of routine production and manufacturing procedures to support processes and ensure compliance with regulatory requirements. The Manufacturing Assistant will work with the Drug Product team to ensure the successful completion of various cGMP activities. The Manufacturing Assistant will learn and demonstrate proficiency in both the technical aspects as well as the quality systems which govern cGMP manufacturing. Duties include visual inspection of tanks and bulk drug substances, preperation of media/buffers/solutions as needed, preparation of material to be sterilized, and accurate documentation of batch records. Multiple positions avalible.

Akouos is looking for someone that will identify, adapt, and implement methods for the analysis of AAV products both in-process and for release and characterization. Evaluate and implement new biophysical and analytical technologies to improve accuracy, precision, throughput, and robustness of sample analysis. Qualify analytical test methods according to ICH guidelines. Write, prepare and present technical data, technical reports and standard operating procedures (SOPs) for internal use and tech transfer.

A Chemistry Lab Technician will be responsible for formulation preparation or analytical test in direct support of the drug development team, including writing documents and reports. Responsible for the maintenance of lab instrumentation and general lab duties. Analyze test data, recognize results that are abnormal or deviate from those expected. Recognize equipment malfunction and factors affecting measurements and testing. Evaluate and solve problems related to sample preparation, variation and processing.

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.

As a Lab Technician, you will be responsible for the detailed, thorough cleaning, line clearance, and segregation of GMP-Source production areas and associated equipment while wearing appropriate gowning. You will assist with training of other lab technicians and writing and completing Standard Operating Procedures. You will completing necessary equipment and facility control task requirements (like laboratory water sampling, and pH and conductivity calibration), along with other assigned duties.

Responsible for gathering, analyzing, and generating global clinical evidence for both the Ortho and GP channels. Support of development of regulatory clinical evaluations, as well as clinical summaries for submissions to regulatory bodies. Additional duties include reviewing existing literature and providing summaries for cross-functional teams to use, clinical evidence gap analysis, and publication planning and development.

 The position necessitates Next-Gen Sequencing (NGS) experience to run bulk- and single cell RNAseq experiments, including library construction for Illumina sequencing. Responsibilities include preforming next-gen sequencing sample preparation and quality control for single-cell RNAseq (SMARTseq, 10x chromium, Illumina Nextera XT and TruSeq), as well as indepedent maintance/stocking of the lab.

The QC Specialist is responsible for supporting the release of commercial products. Their primary responsibility is to perform routine in-process and final product flow cytometry analysis, CD34+ enumeration (ISHAGE) and immunophenotyping of raw tissue lots in accordance with required release timelines while ensuring compliance with internal procedures and specifications.

The Clinical Research Associate performs monitoring visits to ensure compliance with ICH-GCP guidelines, local regulatsion, corporate SOPs. Independently oversees and manages multiple sites within one or more protocals to ensure compliance through onsite visits, services as a primary point of contact, preperation of manuals, consent documents and info. sources, and participating in project team meetings.

The Research Associate is responsible for assisting senior R&D staffs to design, develop, and validate clinical diagnostic assays spanning a wide range of Next-Generation sequencing and microarray technologies. Responsibilities include performing research experiments such as primer design and preparation, PCR, electrophoresis, gel imaging and analysis, Sanger Sequencing, Next-Gen sequencing library preparation, aCGH microarray labeling, and sequencing analysis. analysis, Sanger Sequencing, Next-Gen sequencing library preparation, aCGH microarray labeling, and sequencing analysis.The Research Associate is responsible for assisting senior R&D staffs to design, develop, and validate clinical diagnostic assays spanning a wide range of Next-Generation sequencing and microarray technologies. Responsibilities include performing research experiments such as primer design and preparation, PCR, electrophoresis, gel imaging and analysis, Sanger Sequencing, Next-Gen sequencing library preparation, aCGH microarray labeling, and sequencing analysis. analysis, Sanger Sequencing, Next-Gen sequencing library preparation, aCGH microarray labeling, and sequencing analysis.The Research Associate is responsible for assisting senior R&D staffs to design, develop, and validate clinical diagnostic assays spanning a wide range of Next-Generation sequencing and microarray technologies. Responsibilities include performing research experiments such as primer design and preparation, PCR, electrophoresis, gel imaging and analysis, Sanger Sequencing, Next-Gen sequencing library preparation, aCGH microarray labeling, and sequencing analysis. analysis, Sanger Sequencing, Next-Gen sequencing library preparation, aCGH microarray labeling, and sequencing analysis.The Research Associate is responsible for assisting senior R&D staffs to design, develop, and validate clinical diagnostic assays spanning a wide range of Next-Generation sequencing and microarray technologies. Responsibilities include performing research experiments such as primer design and preparation, PCR, electrophoresis, gel imaging and analysis, Sanger Sequencing, Next-Gen sequencing library preparation, aCGH microarray labeling, and sequencing analysis. analysis, Sanger Sequencing, Next-Gen sequencing library preparation, aCGH microarray labeling, and sequencing analysis.

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

Amgen is seeking an Engineer – Purification at its main headquarters in Thousand Oaks, CA to join the Drug Substance Process Engineering team and will apply process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing at Amgen’s Thousand Oaks site. Duties include transfering processes and perform process improvements from the laboratory into the manufacturing facility and between manufacturing sites, provide on-the-floor technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation, and provde technical support for process related deviations.

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.

As a member of the Final Product Technology Early Development organization, the Engineers’ work will focus on advancing a range of device technologies from traditional to novel as candidates for Amgen’s combination products portfolio. The scope of traditional technologies would include devices such as; fluid transfer devices, pen injectors, and micro-infuser delivery pump systems. The qualified candidate will ensure successful entry of these technologies into short-cycle robust device development, while ensuring that the technologies improve the patient experience for Amgen’s therapies. The Engineer will work closely with cross-functional team members and business stakeholders.

This position will be responsible for the quantitative determination of gene expression magnitude and copy number pertaining to Gene Therapy constructs in cell-based and in vivo models. Duties include isolation of mRNA from cell/tissue cultures, designing of qRT-PCR/ddPCR probes, selection of representitive stable control genes, propagation of cell lines transfection/transduced with gene therapy targets, data analysis and 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).

The validation engineer is responsible to perform validation and conducting development studies. This role is also responsible for monitoring, and analyzing to assist in improvising pharmaceutical systems and processes.

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 Research Scientist I/II is expected to demonstrate expertise in both the theoretical and practical aspects of organic chemistry. In this role, you will: synthesize compounds efficiently using literature or in-house notebook procedures, purify synthesized chemicals to an appropriate degree, the scientist will be able to use the full range of chromatographic, crystallization, and distillation techniques, analyze and identify compounds using a good range of modern separation and spectroscopic techniques. This will include interpretation of TLC, HPLC, polarimetry, IR, and NMR spectra of moderate complexity.

The 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).

This position will assure the quality of documentation and data, and assigned disposition of batch records for raw materials, packaging components, finished product release and stability documents. This position is also responsible for providing support to the Manufacturing and Packaging operations to ensure relevant procedures are followed and meet cGMP requirements.

As a Laboratory Generalist you will perform laboratory testing that helps veterinarians diagnose and treat pets across the United States. You will be using automated analyzers, microscopes and other laboratory diagnostic tools to perform analyses and tests that diagnose animal illnesses, injuries and diseases in support of veterinarian animal treatment. You will be responsible for setting up and running lab tests, and reading and releasing results according to SOPs (Standard Operating Procedures). You can expect to specialize in one or more of the following areas: Hematology, urinalysis, chemistry/endocrinology

The Lead Laboratory Tech you will support the Serology work flow providing guidance and training, and jumping on the bench to ensure quality work is completed on time. The Lead Technician will assist in leading the team through the shift while encouraging an atmosphere of teamwork, integrity, and respect.

We seek a highly motivated individual to join a dynamic team engaged in basic reserach. The candidate will be responsible for performing basic microbiology testing for various applications in medical device manufacturing and product development. The team member fulfilling this position should be a highly motivated, hands-on experimentalist who thrives in a collaborative, multidisciplinary environment. Emphasis is on the ability to successfully perform experiments under supervision and interact well in a team environment.

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.

This position is responsible for performing routine testing of raw materials, intermediates, and finished product to support product development. Works with minimal supervision to assist in analytical method development and pre-validation. Interacts extensively with Product Development and Quality functions to proactively deliver Analytical Development supports and to leverage analytical sciences to characterize and understand formulations and novel 3DP (three-dimensional printing) manufacturing processes. In addition, this position is also responsible for writing protocols, development reports, and SOPs (standard operating procedures); training others on analytical techniques; being familiar with USP/NF (United States Pharmacopeia/National Formulary) analytical procedures; and maintaining an understanding of cGMPs (current Good Manufacturing Practices) and ICH (International Conference on Harmonization) guidelines.

The Associate will be responsible for Archer Custom assay manufacturing, inventory, quality control, and process development. Job responsibilities will involve a variety of activities including: Manufacturing of custom AMP assays, inventory management, QC of manufactured products, use of scripts and programs for assay specific processes, and process development.

The Regulatory Affairs Associate, reporting to the Regulatory Affairs Manager, will help develop, implement and maintain the Regulatory Processes within the Quality Management System (QMS), including creation and maintainenance of the documentation associated with filing for high risk medical device for the US and OUS submissions.

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.

Under general supervision, the Laboratory Technician is responsible for working collaboratively with Chemists and performing integral support tasks to ensure overall efficient testing of samples. Functions include adherence to QMS, following of safty rules, oral and written instructions, prepare reagents and solutions, and prepare and document data.

This position is responsible for maintaining the cleanliness of the laboratory, the organization of supplies, reagents and standards. Additionally, this position is responsible for the daily calibration and/or verification of the balances and pH meter. The employee will have basic knowledge of commonly used laboratory concepts, practices, procedures and instrumentation and will perform limited tests under supervision.

Arrowhead is seeking a highly motivated biologist to join our growing Biology Department. The successful candidate will be joining a team dedicated to discovering novel anti-fibrotic targets. S/He will be expected to: Design and execute/conduct in vitro or in vivo studies to facilitate drug discovery and development in various fibrotic disease areas, execute cell based functional screening assays, identify, generate, and optimize cell models and assays to achieve project goals, and present research findings to project teams and governance bodies and prepare technical reports

Assists the study team in running the day to day operational activities of clinical studies. Assist in the development and maintenance of Electronic Trial Master File (eTMF) and Electronic Data Capture (EDC).

In this role you will perform chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with cGMP, ACC SOPs, and FDA Analyst has working knowledge of relevant QC techniques, policies and procedures to perform QC tasks and document results. Analyst receives minimal supervision on routine assignments and detailed instructions on new assignments.

Perform and document routine tasks related to sample processing and assays using written operating procedures, standard laboratory methods and/or basic laboratory techniques, functions and equipment.

In this position, the successful candidate will apply her/his skills and expertise in protein biochemistry to assist in purifying protein targets bound by Atreca antibodies so that they may be identified using protein sequencing techniques. These methods include immunoprecipitation, chromatography and other protein biochemistry techniques.

This highly motivated candidate will work within a small multidisciplinary project team, helping to support a focused research effort into phototherapy processes to treat the eye. This individual will also be responsible for conducting laboratory-based research, including implementing and executing experimental assay protocols with a focus on timely and accurate results. Accurate and timely recording of data in lab notebooks and electronic files will be a priority.

The Quality Assurance Specialist is an individual contributor who solves a variety of issues following cGMP regulations and company standards.

The Quality Assurance Associate Specialist is an individual contributor who solves a variety of issues following cGMP regulations and company standards.

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 

Perform sampling to support the Environmental Monitoring Program; Use laboratory instrumentation and computer systems to collect and record data.

Conduct microbiological analyses on raw materials, in-process and finished products; Collect samples related to Environmental Monitoring program at Baxter manufacturing area.

Conduct critical biological, chemical and physical analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Baxter manufacturing facilities. Work under minimum supervision.

Responsible for providing supervisory support to Quality Manager. Supervises the product and process testing, calibration, release, documentation, complaint reduction required by: Corporate specifications, Plant Standard Operating Procedures, FDA regulations, ensure compliance with GMP/QSRs and all applicable ISO and Country Standards, and Corporate/Plant goals.

Responsible for the outgoing quality, safety, and efficacy of product produced at Mountain Home (relative to Chemistry Laboratory analyses) involving complex routine and non-routine testing and validation in the Chem Lab.

Participates in the production of life saving gene-modified cellular product for Bellicum

Assist in the characterization of novel diagnostic biomarkers and therapeutic targets for Alzheimer’s and Parkinson’s disease using standard molecular biology techniques

In this position you will primarily be responsible for manufacture of cell culture products in a controlled environment using aseptic technique, media preperation, equipment inspection, and steam-sterilization. Other responsibilities include maintaining parts and equipment, maintaining supply stock, and cleaning of the manufacturing area.

Responsibilities as a Research Associate include the application of molecular biology techniques to clone and express recombinant antibodies/proteins of interest, build and modify prokaryotic/eukaryotic expression vectors, and perform protein analysis and purification. Experience working with mammalian cell culture and DNA cloning are a plus but not required.

Novus Biologicals, a Bio-Techne Brand, is seeking a full-time Research Associate to join our antibody cpurification team. The responsibilities of this position are to perform routine antibody purification and quality control testing, meeting all deadline and quality metrics. Record all information on production worksheets and update production logs as necessary. This is a dead-line driven position requiring a motivated individual to keep up with demand while still producing consistent and high quality products according to specific SOPs. Excellent attention to detail, the ability to multi-task and perform repetitive tasks in a fast-paced lab environment are a must. Send a cover letter along with your resume describing how your skills and experience relate to this position. Key Responsibilities: Perform antibody purification in strict accordance to SOPs Must be able to produce a consistent and high-quality product Record all antibody production information on worksheets for data analysis Provide support to technical services department with scientific feedback Must be self-motivated and able to work in a team environment towards a common goal Must be willing to take constructive feedback, learn from mistakes and work towards the goal of producing high quality products in a timely fashion.

Perform RNAscope-based assays to support new product development and optimization, clinical assay development and validation, and provide customer service. You must be willing to learn new techniques quickly and adapt to shifting priorities in a fast-paced growing environment. Key Responsibilities: Design and conduct experiments to improve ACD’s technologies. Develop new applications of ACD’s technologies. Record, analyze, and present results to senior/other research staff. Supervise junior staff. Develop original solutions to problems. Keep up to date with relevant scientific and technical developments.

Bio-Technical Resources is seeking an Assistant Research Scientist to work with supervision as a microbiologist and molecular biologist as part of a team developing new strains for the production of antibiotics, enzymes, metabolites, and proteins.

This position will entail developing novel assays kits and performing service projects. The assay kit development will utilize colorimetric, fluorescent and luminescence methods for both liquid based assays and paper based test strip formats. This candida

The CRC I plans, coordinates, evaluates, and manages the care of both the participants and the data for their assigned research projects. The CRC I follows study-specific protocol guidelines and communicates and interacts with Investigators, clinic staff

The Corporate Quality Knowledge and Content Management team is responsible for developing and delivering the strategies, methods and tools used to identify, capture, manage, store, and deliver all information assets (knowledge, content, and records) relat

The Product Development Associate I position is an important member of the New Clones Team, which develops new antibody-producing cell lines for BioLegend products. The position is responsible for basic tissue culture responsibilities. This is a great opportunity to enhance your knowledge in the biotechnology industry and to be part of BioLegend, a fast growing company that will provide you with the skills and experience necessary to thrive in the Biotech Industry.

The Quality Control Associate will function as an integral member of the Cell Biology-Quality Control group within the Molecular Immunology department. The primary job functions for this position include polyclonal antibody purification, affinity gel products manufacturing, quality control of cell biology for polyclonal and monoclonal antibodies and associated products, troubleshooting and communicating with supervisors regarding any quality control or manufacturing related problems, and keeping all documentations up to date.

Primary responsibilities include animal work, buffer preparation, mammalian cell line handling, preparation and maintenance of materials used for hybridoma selection. Additional responsibilities include hybridoma screening via ELISA and Western Blot.

The primary responsibilities include performing experiments (e.g. cell culture, cell preparation and flow cytometry testing), analysis and reporting of data, maintaining accurate documentation, use internal company databases for product filing and retriev

The main responsibility for this position will be to assist in the large-scale manufacturing of magnetic nanoparticles conjugated with proteins such as streptavidin and antibodies according to established Standard Operating Procedures (SOPs). Other duties

The Immunoassay Associate will work closely with an experienced scientist on the product development team within the group and will be responsible for developing cutting edge research products utilizing bead-based sandwich immunoassay and flow cytometry t

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 experimen

The Quality Control Associate will function as an integral member of the Cell Biology-Quality Control group within the Molecular Immunology department. The primary job functions for this position include polyclonal and monoclonal antibodies and associate products, polyclonal antibody purification, affinity gel products manufacturing, and troubleshooting and communicating with supervisors regarding any quality control or manufacturing related problems, and keeping all documentations up to date.

The Research Associate position in Cell Biology group will support the development of new antibody and ancillary products. This position will play an integral role in antibody characterization for applications such as Western Blotting, immunofluorescence staining, immunoprecipitation, and Chromatin immunoprecipitation.

This position will work in magnetic cell separation production team to manufacture magnetic nanoparticles and nanoparticle-biomolecule conjugates. Other duties will include maintenance of laboratory instruments, lab supplies, buffer preparations and cleaning glassware.

The Manufacturing Associate will be an important member of a fast growing team that will support kit production to ensure the success of the team. This is a great opportunity to enhance your knowledge and gain experience in a highly competitive biotechnology industry.

The Research Associate is part of the development team responsible for developing new immunology research reagents. The responsibilities for this position involve exploring new technology and developing new methods under the guidance of research scientists. The position will also support the antibody manufacturing teams by troubleshooting and optimizing processes for continuous improvement.

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.

Perform routine and semi-routine analysis of drug product formulations using chromatographic (reverse phase, size exclusion and ion exchange HPLC), spectrophotometric (UV, CD, florescence), calorimetric (DSC, ITC), microscopy and standard wet chemistry techniques.

Successful candidates will join a dynamic interdisciplinary group which will develop and commercialize the major gene therapeutics for several genetic diseases.

The employee will be responsible for the scientific/technical aspects of assigned preclinical studies, including animal handling, cell culture, general biochemical techniques, such as western blotting and ELISA. The position's primary purpose is to assist the preclinical team with planning and execution of in vitro and in vivo experiments.

Work in a small team of engineers developing internal production processes and commercial products for the life sciences instrumentation market. Our technology platform comprises software, instruments, consumable micro-fluidic cartridges and immunoassays. Our initial development phases require clever application of engineering, physics, instrumentation, control systems, data processing algorithms, firmware and software to achieve robust repeatable reliable biological measurements.

The Field Vascular Intervention Specialist I is an entry level position that provides field support for the sales team and clinical studies for coronary products, including product-specific and clinical protocol training, data collection and device implant participation.ﾠ The ability to make recommendations necessary to promote medical acceptance of the vascular intervention products and to be the field technical expert on the devices are a required asset.

The new Sr. Associate Scientist will develop and support Next-Generation Sequencing-based assays to evaluate gene-editing based therapeutics for clinical applications. The new hire will also contribute to immunotherapy and hematopoietic stem cell (HSC) platforms.

ﾠThe candidate will interface with the internal Quality Control GMP Testing Lab, Process and Analytical Development groups, and Supply Chain for the maintenance and shipping of critical reagents and critical test articles. A strong technical background in cell biology, biochemistry, and/or molecular biology will be utilized in the role. This position may require hands on laboratory.

The ideal candidate will lead target identification effort using internal and external datasets, as well as support scientific computation and bioinformatics effort from early target discovery, optimization to late stage translational medicine investigation. This will be an exciting opportunity to be involved in various stages of the drug discovery process using your computational and analytical skills, and working in an innovative, motivating and collaborative environment.

Executes routine unit operations in Downstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures.ﾠﾠﾠﾠﾠ

Executes routine unit operations in Downstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures.ﾠﾠﾠﾠﾠ

Executes routine unit operations in Downstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures.ﾠﾠﾠﾠﾠ

The Scientist I applies engineering/scientific skills and commitment to quality to execute experiments and complete data analysis in support of projects. This individual will gain knowledge in scientific/engineering concepts, business practices, and core business principles.ﾠ Work will be completed in office and Microbiology laboratory settings.

Boston Scientific is seeking a highly motivated and experienced engineer with expertise in new product development to lead the design and commercialization of new cutting edge technology.ﾠ

Quality Engineer II who is responsible for the direct support of medical device manufacturing lines, specifically within the Core Tech Polymers production area at the Maple Grove site. This includes driving continuous improvement in product quality and compliance, managing the control of non-conformances, and being a key partner to the Production and Manufacturing Engineering teams.

The R&D Engineer I will developﾠproducts, materials, processes, or equipment for complex systems under limited supervision/guidance. You will compile, analyze, and report operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.

The position is expected to execute and provide on-the-floor oversight of all fill finish department manufacturing processes while strictly adhering to standard operating procedures, cGMP regulations, environmental health and safety guidelines, and any other regulation which could apply. The incumbent will demonstrate skills of a drug product specialist, which include: developing process understanding of primary work areas (formulation, filtration, filling, autoclave, capping, inspection, cleaning, isolator knowledge, etc.), executing activities on the manufacturing floor in accordance with schedule, oversight of fill finish manufacturing activity, participation in all departmental manufacturing and support functions, and providing a moderate level of troubleshooting. In addition, the specialist is expected to:

The Manufacturing Associate 4 is an associate with a moderate level of technical expertise and experience. An MA4 may perform complex activities outside of routine manufacturing operations commensurate with their experience and training. An MA4 participates in the day to day operation of a cGMP compliant Manufacturing facility. Responsibilities include performing basic to complex activities related to operating bioprocess manufacturing equipment, completing the associated documentation of those activities, monitoring assigned processes using automated production systems and controls under limited supervision. Other activities include keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities. The MA 4 must be technically capable with a good theoretical comprehension of general biopharmaceutical manufacturing equipment, principles and processes and have a good understanding of current GMP and safety standards and be able to apply this knowledge in a GMP manufacturing environment during performance of routine activities.

The document specialist 3 is an associate with a moderate level of expertise and experience with general biopharmaceutical manufacturing equipment, principles and processes and has a good understanding of current GMP and safety standards. The DS3 collaborates with subject matter experts and technical specialists to plan, develop, author, edit, format, illustrate, update, and create new standard operating procedures and other related documentation such as PBRs, logbooks, job aids and technical reports in support of the cGMP compliant Manufacturing facility. Responsibilities include maintaining established documentation design and quality standards, using performance tools (Human Performance) and managing documentation workflows to meet departmental needs. Additional responsibilities may include administrative duties to manage and process controlled documents for the manufacturing facility.

This position will work in the GMP compliant QC Laboratories to 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. Will perform routine assays and testing including PCR, real time PCR, agarose gel electrophoresis, SDS-PAGE, immuno blotting, ELISAs, immunocytochemistry, and infectivity and reporter gene based cell assays using insect or mammalian cell lines. 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 incumbent will be expected to technically interpret, write controlled documents and reports, and review data produced by self and participate in laboratory investigations. Will interact with other departments to ensure that sample flow, supply chain, and equipment disposition are correctly maintained.

Perform weekly site safety/environmental inspections noting potential deficiencies and areas for improvement. Then working with the appropriate parties to identify address the root cause and correct any areas of concern.

The Technician III, Instrumentation & Controls is responsible for supporting Brammer Bio facilities in Cambridge, MA with a scope encompassing building and utility systems for GMP manufacturing, process development, quality control, and warehouse operations. Will perform planned and unplanned calibrations and repairs of instrumentation and laboratory equipment. Will respond to instrumentation and equipment related issues that arise during facility operations. Will create and maintain relationships with other sites to develop and promote best practices. Will uphold, define, and police safety procedures and safe work practices. Will ensure work performed is in compliance with cGMP regulations and Brammer Bioﾒs SOPs. Will work closely with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams to complete all responsibilities.

This position will work in the GMP compliant QC Laboratories to 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. Will perform routine assays and testing including PCR, real time PCR, agarose gel electrophoresis, SDS-PAGE, immuno blotting, ELISAs, immunocytochemistry, and infectivity and reporter gene based cell assays using insect or mammalian cell lines. 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 incumbent will be expected to technically interpret, write controlled documents and reports, and review data produced by self and participate in laboratory investigations. Will interact with other departments to ensure that sample flow, supply chain, and equipment disposition are correctly maintained.

Perform routine utility monitoring and in-process testing in accordance with SOPs, safety, and cGMP guidelines to support the release and stability of finished products, raw materials, in-process materials, and various components.

This position in Toxicology Operations is crucial for the support of the portfolio by co-ordinating successful conduct of toxicology studies in DSE, NBR. The Biological Technician group is at a critical mass due to the departure of a Biotechnician and not filling this position will critically impact productivity, result in gaps in compliance and portfolio support.

Formulation, Aseptic Filling, and Packaging. The Production Technician ensures a clean, safe workplace and quality production of drug product adhering to current Good Manufacturing Practices. (CGMP's).

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 Animal Technician to join its R&D team at its facility in the Bay Area.ﾠﾠThe candidate must be motivated, enthusiastic, professional and committed to working as a team player.ﾠﾠThe ideal candidate enlists confidence, comfort and a working knowledge of laboratory animals, with a background in animal husbandry, restraint and handling.ﾠﾠIn addition, experience with injection and blood draw techniques, along with rodent surgery and anesthesia experience is desirable.ﾠﾠThe candidate must have the ability to effectively communicate with coworkers, take direction from supervisors, and be accountable for their actions.ﾠﾠThey must possess a strong attention to detail and always strive to perform quality work.ﾠﾠThis is an excellent opportunity to utilize and advance the ideal candidateﾒs laboratory animal skills in a progressive, state-of-the-art and diverse facility.

The Chemist II will be developing the use of innovation and creativity in exploring alternative approaches to problem solving. The individual may be required to assist in the creation and/or revision of company SOPs.

The Validation Engineer will be instrumental in the design, schedule, execution, and evaluation of scientifically and statistically sound qualification experiments. These experiments define and demonstrate that critical Cleaning, Controls, Equipment, Facilities, Processes, and Utilities function in a consistent and repeatable manner, in accordance with a host of regulations and policies affecting final product integrity.

The Assistant Scientist, Analytical Development - Formulation position will perform a variety of laboratory procedures to support Analytical Development. The Assistant Scientist, Analytical Development - Formulation will perform daily work assignments accurately and in a timely and safe manner. The Assistant Scientist, Analytical Development - Formulation will independently evaluate, select and apply standardized scientific and techniques; assignments have clear and specified objectives, and require the investigation of a limited number of variables. This position relies on limited experience and exercises judgment within defined procedures and practices in making minor adaptations and modifications.

The Chemist will be responsible for testing raw materials, in-process, finished product, and stability samples as well as investigating out of specification test results.

Ensures any products that are not qualified internally have batch-specific data provided by the supplier;Manages vendor data, assuring it is stored for easy retrieval by Tech Support and others.

Restock and clean lab as needed.Understand basic laboratory concepts and be able to perform basic lab techniques, including routine and preventative maintenance.ﾠ

The Bioreactor Technician will work directly with a range of scientific, technologies and equipment supporting the production of biological processes in vaccine preparations. The Bioreactor Technician is responsible for direct involvement into manufacturing processes, trouble-shooting equipment issues, and involvement in optimizing existing processes to achieve the highest process quality, yield and efficiency. The candidate must be willing to work cohesively in a team environment to solve manufacturing issues across the entire Ceva Biomune Campus. The Bioreactor Technician will apply both microbial and engineering principles and concepts to new and existing manufacturing processes. The incumbent will work cross-functionally with Maintenance, Engineers, and Scientists; on the operational floor to develop and support optimal manufacturing workflows following aseptic technique and cGMP procedures. The Bioreactor Technician will work directly with a range of technologies and equipment including microscopes, centrifugation, roller bottles, cell cubes, bioreactors, filtration skids. The Technician will work directly with cell culture and viral propagation techniques, buffer and equipment preparations, cell culture and bioreactor operations, bacterial and fermentation operations, and inactivation methods following aseptic technique and cGMP procedures

To assist in the development and licensure of viral, bacterial, recombinant and/or parasitic vaccines as well as new label claims or product improvement research of the licensed vaccines.

Assist with the Companyﾒs Research & Development program; Assist with the histology laboratory tasks, including the characterization of Tumorgrafts by tissue embedding, sectioning, H&E or IHC staining.

Support in vivo oncology studies in mice as a member of the Study Services Team.

The Associate Quality Assurance (QA) Auditor is an entry level trainee position. The Associate QA Auditor will perform audits of quality control testing data for routine assays, incoming and in-process materials, process documentation and labeling to assure accuracy and compliance with Good Manufacturing Practice Regulations (GMP) and Standard Operating Procedures (SOP). Additional responsibilities include: Participate in internal facility/SOP procedural audits to obtain a clear understanding of the Quality Systems and regulatory requirements for the manufacturing/testing operations. Participate in new employee orientation and associated GMP training to obtain an understanding of GMP regulations and site SOP requirements.

The Research Technician I will perform technical laboratory activities in support of client studies or procedures.

Generate and record data with minimal supervision in the performance of studies. Responsible for handling and processing samples, and performing accurate data collection and reporting. Perform laboratory tasks by various basic methods.

In this position, the Laboratory Technician II will perform analytical methods independently as specified in standard in-house SOPs and Client Test Methods and other written procedures. Under direct supervision, perform method development work as assigned. In addition, perform reagent preparation and laboratory maintenance/monitoring, prepare reagents and test samples, and analyze data and report results of experiments and procedures. For both GMP and R&D grade routine testing, generate analytical data and technical report(s) on-time with respect to internal and client deadlines and maintain a weekly schedule to ensure all timelines are met. May be required to co-ordinate laboratory functions such as updating of sample-tracking databases and maintenance of consumable or HPLC column inventory(s). Must comply with all pertinent regulatory standards regarding environs, equipment and testing services. Make detailed observations and maintain clear, detailed, accurate and timely documentation of all laboratory work. Perform assay and equipment troubleshooting under guidance from senior members of the group. Compose high quality written reports such as deviation reports and change control documentation under guidance. Review and edit SOPs, protocols and testing documentation.

The Research Associate in Bioanalytical is responsible for: following established methods to quantify chemical entities according to applicable Standard Operating Procedures (SOPs) and/or GxP regulations. This individual demonstrates proficiency in the use of instrumentation and laboratory techniques. This individual contributes to the department by completing assigned projects on time, participating in process improvement initiatives, and communicating effectively with others.

The Research Associate in Test Material Control (TMC) is responsible for: preparing, sampling, and dispensing formulated test material according to applicable Standard Operating Procedures (SOPs) and GxP guidelines. The individual in this role: completes projects on time while maintaining quality and efficiency; communicates effectively with management, internal customers, and team members; assists others with their duties; and may assist with troubleshooting formulation issues.

Under direct supervision, responsible for performing basic daily laboratory and clean room tasks as they relate to the operations performed within the Manufacturing department, including cell banking and vaccine preparation activities.

A Research Technician 1 is responsible for providing humane care to all laboratory animals and to perform assigned technical and administrative functions within the guidelines / requirements outlined in a protocol or Standard Operating Procedure (SOP), thus producing sound, reliable data from which to evaluate the efficacy or toxicity of a test compound

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.

The Research Associate position is responsible for: quantifying, characterizing, synthesizing and/or modifying chemical entities according to applicable Standard Operating procedures (SOPs), established methods and/or GxP regulations. The individual in this role demonstrates proficiency in the use of applicable analytical and biochemistry instruments and laboratory techniques, and contributes to the team by completing assigned projects on time, contributing to process improvement initiatives, and communicating effectively with team members and customers.

The Laboratory Operations Assistant position is responsible for facilitating and/or directly conducting administrative departmental functions and other miscellaneous functions, as assigned.

A Clinical Laboratory Assistant is responsible for: managing sample containers, data, and communications for accurate and timely tracking and disposition of samples and data; or, for processing blood samples for multiple species of animals. Individuals in this role use effective communication and interpersonal skills in a collaborative team environment.

The Research Associate position is responsible for following established methods to quantify chemical entities according to applicable Standard Operating Procedures (SOPs) and/or GxP regulations. This individual demonstrates proficiency in the use of instrumentation and laboratory techniques. This individual contributes to the department by completing assigned projects on time, participating in process improvement initiatives, and communicating effectively with others.

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

Under direct supervision, perform basic daily laboratory tasks as they relate to cell culture and media preparation in the Cell Culture group.

Performs technical laboratory activities in support of client studies or procedures. Performs analysis of data for quality and completeness and determines if results are as expected. Records data in compliance with company and regulatory policies and standards to meet quality and accuracy requirements. Prepare study materials and study books prior to clinical pathology bleeding days. Operate basic to moderately complex analyzers (e.e., hematology and co-ag analyzers) and process toxicokinetic samples. Assist in the performance and review of study ordered parameters and computer input of raw data.

The responsibilities of this role as Microbiology Technician I will be specific to the Environmental Monitoring division of the Microbiology department.ﾠ

Responsible for performing basic to moderately complex laboratory work in collaboration with departmental staff.

This position will be involved in all aspects of studies supporting the bioanalysis of drug molecules in multiple matrices.ﾠ 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.

Major responsibilities will involve design, synthesis, purification and characterization of novel chemical entities and the management of general chemistry lab operations under the direction of senior scientific staff. The qualified individual is expected to contribute in process development and scale-up of key intermediates.

Perform multi-step organic synthesis in solution and/or solid support: Optimize conditions to achieve desired yield; perform and interpret data analysis such as LC/MS and NMR; perform purification steps such as extraction, recrystallization, silica gel column chromatography and LC/MS purification; perform cGMP synthesis of pharmaceutical ingredients; and perform process development and scale-up for kilogram quantities; and clearly record and communicate results and challenges to coworkers/supervisor.ﾠ

The Clinical Research Coordinator (CRC) is primarily responsible for coordinating the operational aspects of ongoing clinical projects to ensure that the clientsﾒ goals of time, cost, and quality are met. The CRC may serve as the primary contact with the client to ensure appropriate communications, project budget management, and meeting of timelines. The CRC may also serve as the project lead responsible for directing internal teams in the execution of the protocol and ensuring that all staff working on any given protocol have been properly delegated by the Principal Investigator and adequately trained on the protocol.

The Clinical Research Associate II monitors investigational sites to ensure subject safety and provides high quality data review and reporting in compliance with the Clinipace and/or client Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, ISO14155, and other applicable regulations. Builds, manages and supports site relationships while serving as liaison between the Sponsor and assigned sites.

Analyze research samples by LC/MS/MS and other instruments as needed

Coordinating with investigator sites to ensure compliance with protocol and maintenance of patient safety

The successful candidate will be responsible for manufacturing DNA Nanoballs as required by R&D, prepare libraries, formulate and assess a variety of reagents, run different biochemistry experiments, operate sequencing instruments, manage data, troubleshoot, and analyze data using various proprietary and nonproprietary tools.ﾠﾠﾠﾠﾠﾠ ﾠ ﾠ ﾠﾠﾠ ﾠ ﾠ ﾠ ﾠ ﾠ ﾠ ﾠ ﾠ ﾠ ﾠﾠ ﾠ ﾠ

The successful candidate will support and develop automation solutions related to the genetic engineering and screening of industrial microbes.

The successful candidate will support and develop automation solutions related to the genetic engineering and screening of industrial microbes.

Adherence to all company procedures. Perform sampling of in-process and raw materials. Release of materials. Manage the retain program. Perform weekly cycle audits. Check in-process work. Oversight of environmental monitoring and water systems. Perform cleaning verifications.

This position of Research Scientist is in the Mechanics and Reliability department of the Science and Technology Division of Corning Incorporated. This department combines deep knowledge of the mechanics of materials with reliability science and practice to discover and explore failure modes in materials. The candidate should have a track record of combining experimental work with fundamental understanding to yield new insights into the mechanics of materials. Our projects are fast-paced, and we expect our scientists to produce an experimental and modeling strategy that produces knowledge from which program and product decisions can be made.

Test proof of concept/feasibility for new manufacturing processes or significant capability improvement of existing manufacturing processes.

Solve problems and improve processes based on fundamental understanding and structured problem solving methods such as KT, Designed Experimentation, or Six Sigma.

Working with a global team of technical experts to develop new technologies for glass substrate manufacturing

Measurements Systems engineer is a technically diverse and challenging role that supports the glassmaking process for optical fiber manufacturing. The primary mission is to apply technical knowledge to advance manufacturing capabilities. Project assignments require a broad application of engineering skills with a specific focus on measurements and machine vision. Primary objectives include process improvement, cost reduction, process and raw material optimization, engineered safety improvements, and ensuring manufacturing readiness for new processes. Comprehensive process understanding is an expectation and requirement for success.

Apply knowledge of engineering principles and practices to effectively accomplish technical assignments and projects. Make decisions independently based upon sound engineering and scientific methods. Strengthen the Product Quality Architecture within the plant by driving fundamental understanding and continual improvements that positively influence the Quality Management System.

We currently seek to hire a full-time Clinical Laboratory Scientist to assist in sample processing & analysis in our highly-automated laboratory. You will Interact and communicate with laboratory staff to ensure efficient work flow within our state-of-the-art laboratory.

Manipulation and handling of mice in a lab setting; Ear tagging, shaving, and measuring body weights of mice.

Perform peptide synthesis or purification under close supervision

The primary work functions will be on the production floor, not in an office or laboratory setting. Responsibilities include assisting with investigating deviations relevant to area of responsibility. Responsible for driving continuous improvement on production floor to ensure compliance with cGMPs. Real time review of batch records, including critical processing steps with production floor presence.ﾠA very high level of attention to detail is required.

Perform real time documentation (batch record, logbook, etc.) review concurrent with manufacturing operations on the manufacturing floor.

Researches, develops, tests, recommends and implements new or revised packaging components and initiates the corresponding component spec.

Cell Culture experience with immortalized cell lines. (Primary cell experience a plus). Responsible for planning and conducting high and low throughput toxicology screens, processing data to a high quality of standards, and within specified time frames.

Candidates must have experience in a cell culture process development setting, including operation of stirred-tank bioreactors and associated instruments. Advanced troubleshooting and data analysis skills are highly desired.

Takes an active role in assisting with the development, execution and management of the Quality Compliance Team. A QS & C Specialist assists the Compliance Team in the identification and resolution of quality issues and regulatory concerns.

Control manufacturing and engineering specifications for the plant; Implement ICR’s/ECR’s; Maintain plant ISO procedures.

The successful candidate will be an integral member of the R&D team for product enhancements and new product development. This is a hands-on position. Responsibilities include: Test plan development, testing execution, evaluation of test results, limited fabrication, Mechanical and electrical assembly, troubleshooting, and full functional testing including software. As your knowledge and understanding of our products grow you will be expected to provide recommendations for product improvements ranging from function and reliability to improved manufacturability.

The Supplier Quality Analyst ensures suppliers deliver quality product on an on-going basis, while developing supplier capability for future needs. This includes supplier selection & approval, material qualification, material control and supplier development activities. The individual will be responsible for assisting in investigations of nonconforming materials to understand the root cause of failure. The person plans, coordinates, and reports on material projects and supplier performance. The individual must demonstrate sound technical ability and decision making to achieve the desired results. The person will represent QA on development, manufacturing and product improvement projects.

Utilizing a basic knowledge of engineering and problem-solving principles, this position is responsible for a variety of more routine activities regarding the designing, implementation, and maintenance of quality assurance protocols and methods to ensure external safety, quality and compliance with the Company standards and government regulations.

Under guidance and detailed instructions, plans, designs, tests, and develops mechanical systems, parts and equipment. Applies basic knowledge of engineering principles to design simple components and assemblies. Conducts engineering analysis and testing as needed on designs using existing designs and tools. Participates in concept and design reviews and activities. Ensures design requirements and standards are met. Compiles mechanical design documentation and approvals. 100% of time is spent in a resource capacity. Works directly with Marketing, Sales Reps and Surgeon customersﾠin the design of specialty surgical instrumentation to meet the user needs of the requesting surgeon.ﾠ Coordinates manufacturing of specialty instruments with outside vendors and internal machine shop.

Identify the Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes and Critical Process Parameters to arrive at robust formulation strategy.

Develop test plan, test cases, test scenarios based on Users Stories and productﾒs design description to meet business requirements and technical specifications

The Associate Scientist position is an intermediate-level professional position involved in somewhat complex day-to-day activities in a laboratory setting under prescribed processes (protocols, standard operating procedures, methods, etc.).

The Associate Scientist position is an intermediate-level professional position involved in somewhat complex day-to-day activities in a laboratory setting under prescribed processes (protocols, standard operating procedures, methods, etc.).

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.

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.ﾠ Please refer to the job description for additional details.

The Quality Laboratory Technician performs accurate, precise, and timely testing of laboratory samples in accordance with approved methods in both the QC and culture laboratories. Expertise in lab operations, aseptic technique, attention-to-detail and thoroughness are critical components. The Lab Technician will participate in laboratory investigations, equipment qualification, and maintenance by executing well-defined protocols and procedures. Active in identifying, communicating, and participating in opportunities for improvement to lab operations.

The Associate Scientist will develop and perform ELISA and other immunological assay procedures to advance early stage concepts within the Company including review of technical procedures and study protocols, writing portions of study reports and completion of data analyses by manual methods as well as electronic methods to meet the evolving needs of the Company.

The Tech Transfer Process (TTP) Associate will support process validation activities as a member of the Manufacturing Science & Technology (MS&T) Team. S/He will have the opportunity to work on multiple projects ranging from process development studies through process performance qualifications. Two key responsibilities of the TTP Associate are data entry and assisting with the preparation of technical documents (e.g., batch records; protocols; reports). The TTP Associate may also have the opportunity to perform benchtop testing in a process development lab. The ideal TTP Associate will have GMP experience, preferably in process validation, and can demonstrate exceptional attention detail.

You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

Recombinant mammalian protein expression, including target design, transfection, HEK and CHO tissue culture, purification and characterization

The QA Analyst II On the Floor is responsible for assuring the quality of products inspected and Packaged at the Emergent BioSolutions Baltimore Facility.ﾠﾠ The QA Analyst II on the Floor will perform Quality on the floor functions and support packaging activities.ﾠ Our QA Department provides expertise in problem solving and process improvements.ﾠ The QA Analyst II will interact with packaging personnel and the Quality Engineer to provide guidance necessary to maintain and improve CGMP compliance at the company.

The Manufacturing Technician, 2nd shift, is responsible for daily cleaning and sanitization activities throughout the production area and preparation of tubing, equipment, supplies, and other items associated with sterile filling processes.

Responsible for all aspects of validation, sample analysis and data preparation in support of pre-clinical and clinical studies. Ensure all work is conducted in accordance to GLP/GCP regulations.

Responsible for manual/automated production/assembly in compliance with relevant regulations and Standard Operating Procedures.

Develop, qualify and validate analytical test methods for drug product, intermediates and excipients;Design and execute analytical development studies.

Responsibilities will include providing technical service and product introduction to new and existing customers, identifying new customer project opportunities and participation in Polyurethane industry activities to understand the insulation market segment trends and technology drivers.

The Medical Laboratory Technician (MLT) will work in Automated Chemistry area and performs moderate complexity testing. Performs and document quality control and preventive maintenance. Follow good laboratory practices and procedures for compliance.

The Compounding Chemist will be responsible for assisting with the compounding activities of manufacturing solutions and suspensions: weighing, adding and mixing raw materials, sterile filtration, steam sterilization, sanitization, and documentation activities associated with the production of drug products. This position supports the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the U.S. Food and Drug Administration.

This position provides an opportunity to participate in an entrepreneurial company that is bringing its proprietary technology into clinical service. The ideal candidate will have a good understanding of CLIA requirements, will assist in the development and validation of Laboratory Developed Tests (LDTs) for diagnostic and clinical trials testing, and will be responsible for performing testing for a variety of biomarkers.

Responsible for preparing and executing commissioning, qualification, and validation studies for new facilities, processes, and equipment as well as assisting in maintaining the facility, processes, and equipment in a validated state.

Perform routine testing of in-process and finished products, develops test methods, qualification, transfer of methods to Quality and Manufacturing teams with some supervision and carry out special projects independently as required and assigned by Management.

The Product Development Scientist will play an active role in interdisciplinary teams with an overall goal to provide high-quality mass cytometry reagents. The individual will support the execution of new product introduction and sustaining projects. Duties include tasks to support product scale-up, process optimization, technology transfer and process validation.

Responsible for providing technical support to operations in terms of equipment/system/process initial validation and equipment/system/process requalifications. Will participate in process and equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. The individual must become certified to enter Controlled Areas of the plant (class 100, 10,000 and 100,000). The ability to write reports clearly, concisely and accurately; accurately record data and a basic understanding of statistical analysis is also required to perform these duties. Weekends and Off-shift hours are periodically required.

We currently have an opportunity for an Associate Scientist or Scientist, Analytical Development who will conduct all aspects of Analytical Development including method development, experimentation, and record keeping, including developing and implementing methods that meet project needs.

The Associate Scientist Data Reviewer is responsible for the review of all test results and supporting laboratory data associated with raw materials, in-process materials and final product for microbial assessment according to cGMP and company specifications.

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.

The Quality Control Environmental Monitoring Technician is responsible for day-to-day activities required to perform monitoring of aseptic areas and controlled environments.

We currently have an opportunity for aﾠManufacturing Engineer in our Warrendale, PAﾠmanufacturing facilityﾠto provide manufacturing process development support for hardware manufacturing systems.

Responsibilities include routine testing to support product release, raw material release, and cleaning verification. The technician will rely on experience and judgment in order to plan and accomplish goals.

Position is responsible for quality oversight and assistance with Inspection/Packaging processes at the FK Grand Island Manufacturing Facility. Position is also responsible for AQL sampling and AQL related product inspection. Position recommends corrective action in response to deviations noted and assures compliance to SOPs and cGMPs while following and reviewing Good Documentation Practices.

The individual is responsible for independently or as part of a project team, planning, designing, tracking and implementing effective project technical support systems as well as facilitating multiple technical transfer activities (e.g., protocols, batch records, operating procedures, training materials, etc.) to achieve a successful transfer of products. The position will support multiple sites within North America and Europe and reports into the Director of Production and Technology Transfers.

Position acts as the statistical subject matter expert for the facility.ﾠ Plans data collection, and analyzes and interprets numerical data from surveys, experiments, studies, and other sources and applies statistical methodology to provide information for scientific research and analysis.ﾠ Plans methods to collect information and develops questionnaire techniques according to survey design.ﾠ Conducts surveys, evaluates reliability of source information, adjusts and weighs raw data, analyzes and interprets statistics and organizes results.ﾠ The individual will prepare conclusions and predictions based on data summaries.

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

This position will mainly focus on supporting drug development, analytical research and developing activities, as well as cGMP testing

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

The Virology Associate will be involved in the growth of both adherent and suspension cells, the creation of cell and virus banks, virus expansion and cultivation, and the use and development of assays to titer and identify virus and monitor expression of gene of interest with moderate supervision.

Assist with raw material release; Helps prepare monthly metrics for raw material release as needed.

Assist with quality control analytical testing of samples provided to the QC laboratory.

The Associate Scientist – Downstream Process Development will assist in the development and characterization of scalable purification processes, and technology transfer to the manufacturing group as appropriate. This individual will have familiarity with a range of purification technologies including centrifugation, filtration technologies (TFF and depth), chromatographic separations and basic laboratory analytical techniques (SDS-PAGE, spectroscopy, pH/conductivity meters, etc.)

Responds to service calls to evaluate, diagnose, and perform repair and planned maintenance (PM) on customersﾒ basic biomedical equipment. Drives customer satisfaction through service excellence.

This position is responsible for evaluating the manufacturing processes to determine root cause and effect of product non-conformities, improve processes to ensure quality, products and services to adherence of quality standards.

ﾠThe Quality Control Laboratory Technician role is responsible for sample management, quality inspection and manufacturing support.

Setting-up and operating inspection and/or manufacturing tools/equipment such as conventional electrical discharge machines, grinders, precision assembly devices, peen, heat treat, plasma spray, etc.ﾕ Performing basic mathematical calculationsﾕUsing precision gages/fixtures and inspection measuring equipment and interpreting mechanical blueprints, sketches, engineering specifications and drawings, etc., to determine set-ups and operations necessary to complete job tasks. ﾕTraining duties.ﾕ Performing related environmental, health, safety, maintenance, quality, continuous improvement, and production-flow job duties to support plant machinery, equipment, and manufacturing-related initiatives and programs. ﾕMaintaining detailed job task documentation, reports, and records.

This role is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. Responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.

The Lab Application Specialist/Automation Specialist will work with robotics and automation systems in our DNA sequencing labs. The successful candidate will be a member of the Bioinformatics department, with a focus on genomics and high throughput sequencing. Responsibilities will include projects ranging from technical support to workflow development for several robotic platforms, such as Hamilton, Caliper/Perkin Elmer, Beckman, Qiagen, etc.

The Bioinformatics Developer/Engineer supports the development of assays and clinical data analysis tools for the BioReference-GenPath division, which currently includes somatic tumor sequencing and reproductive carrier screening.

Under the general supervision of the Microbiology Director, this management position requires the MT to write clearly, have a sense of urgency and strong organizational skills, pay attention to details, strictly adhere to protocols, maintain extensive and accurate documentation, and be able to think creatively to solve problems. The Microbiology Coordinator is expected to remain current with State, OSHA, CLIA, COLA, and CAP best practices. This position will also serve to cover the laboratory supervision in the absence of the Director or Supervisor.

ﾠA GeneDx DNA Extraction/CAND Lab 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.ﾠ

A GeneDx NextGen Lab Sequencing Technician performs a higher than 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.

The successful candidate would report directly to Lead Scientist in the group and will assist in the optimization of our development processes in the path toward clinical manufacture.

Interact with all personnel levels and departments to help ensure full compliance with organizational, state, federal and other laws and guidelines

Prepare amplified template libraries for high-throughput sequencing

The position is based on San Diego, CA and a title will be Senior/Research Associate working in Quantitative Small Scale (QSS) team under Systems Bioengineering group. The successful candidate will implement custom-designed microbial cultivation assays for quantitative physiology studies in an information-rich and precise way and involve in developing experimental platforms for high-throughput quantitative strain evaluation.

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, including the Chief Commercialization Officer, VP of Sales, VP of Marketing, Sales Team, Operations Team and Medical Staff 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

The Pathology Services Associate I works with laboratory technicians, technologists and a team of physicians to ensure quality and timely diagnostic test results are delivered to clinicians/oncologists and their patients. The primary purpose of the position is to provide support for the Hematopathology departments by preparing reports, and performing quality review of reports.

To independently perform essential biochemical screening and analytical experiments, and interpret analytical data in accordance with the relevant SOPs.

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.ﾠ

Under general supervision, performs experiments that support research activities in the Medicinal Chemistry job family.

As Research Associate, you will participate in an integrated research team aimed at discovering and synthesizing novel chemical entities for various targets. Under the guidance of an experienced Research Scientist you will be responsible for planning, designing and executing multi-step synthesis pathways toward key target molecules, followed by purification and compound characterization. Communication of results, methods and conclusions to departmental colleagues is essential. Collaboration with colleagues across disciplines, participation in project team meetings, and contribution toward creative problem solving are all encouraged.

Operate high-throughput semi-automated NGS processes (DNA and RNA seq)

You are more interested in operating the state of the art laboratory automation instruments to validate genetic modifications in many organisms than pipetting at the bench. You are also into tracking processes carefully and easily with custom software tools and recognize the importance of quality control and assurance. And you know that sometimes you just have to do things the "old-fashioned way" to make sure everything is working right.

Assists in all Upstream Development/Manufacturing activities including; cell culture, cell banking, media optimization, seed train design, feed strategy, bioreactor parameter optimization, harvest clarification, and technology transfer to manufacturing.

The job will require establishing product reliability tests, performing appropriate analyses and tasks to ensure the product will reliably meet its requirements.ﾠ The qualified candidate will be expected to provide leadership and guidance to other engineers to establish a reliability competence that will meet the needs for development, manufacturing, and field performance of devices.ﾠ This engineering position will support new product development of products in structural heart applications.

The successful candidate will be involved in high throughput screening of strains/cell free reactions, and/or process development of commercially relevant fermentations/cell free reactions in 10 mL to 150 L reactors. The successful candidate will work hands-on in small teams to execute fermentation/cell free bioprocessing and other associated bioprocess unit operations with a high degree of excellence, in a fast-paced environment. A high degree of flexibility, creativity and initiative is essential for success. Strong technical, organization, communication, documentation, inter-personal, and trouble shooting skills are essential.

Responsible for ensuring compliance with applicable domestic and international standards and regulations through audits and systematic maintenance of effective quality systems. ﾠEnsures that deadlines are met on time and within budget. ﾠLimited interface with other departments and business or marketing partners. Work independently with supervision and exercise judgment within the defined procedures and practices to determine appropriate actions. ﾠ

The Label Verification Technician's primary responsibility is to perform a variety of tasks (i.e. operate labeler machine, inspect labels for accuracy, etc.) related to the labeling of packaged biological products.

The primary role of the RA/SRA is to be responsible for execution of next-generation sequencing laboratory workflows to support scientific research objectives at Gritstone Oncology

As a Research Associate supporting product and technology development, you will work with members within the team and interface with multiple teams including process engineering, clinical operations, research operations, IVD team members, and bioinformatics. You will be hands on in the lab and be required to design, implement, and validate new technologies related to liquid biopsy sequencing assays for the early detection, treatment, and monitoring of all cancer types.

TheﾠClinical Trial Assistant (CTA)ﾠis primarily responsible for the coordination of activities associated with the setup and management of clinical studies under the direction of, or as delegated by a member of the Clinical Trial team. Responsibilities will range from clinical study coordination to data entry projects and general office work.

Will be resonsible for reviewing manufacturing records for accuracy and completeness to ensure compliance as well as timely release.

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. 

Using company procedures and guidelines, the Chemical Process Operator I is responsible for a limited spectrum of duties within the department.  This may include but is not restricted to:  weighing, mixing, equipment cleaning, tank cleaning, tank movement and PM activities, etc. 

Assist the shift lead in a hands-on approach to overseeing production activities including, filling, sterilization, component and equipment prep, and compounding. Completes quality systems activities including commitments, deviations, DCEs, and SOP revisions as necessary. Responsible for meeting budget, quality, and production goals, setting standards, and making employment and staffing recommendations. Interprets manufacturing policies, procedures, and programs

This role will provide optical engineering support to the product development teams tasked with the design of new products within R&D. This role will ensure effective resolution to design related issues with Welch Allyn products, develop product changes to grow the business, ensure compliance with product related standards, and implement continuous improvements in the design of existing products.

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).

The Process Technician will support the installation and qualification of a GMP continuous tablet manufacturing line, highly automated, with Process Analytical Technology enabled control. This position will also support the development and manufacturing activities for drug product and formulation development projects.

The Quality Control Peer Reviewer performs all activities within Quality Control in compliance with Corporate Operating Procedures (COP), Standard Operating Procedures (SOP), Internal Operating Procedures (IOP), and Federal Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Occupational Safety and Health Administration (OSHA), and Environmental Protection Agency (EPA) requirements. They will also perform QC peer reviewing on all relevant records and analytical data in accordance with Operating Procedures (COP), Standard Operating Procedures (SOP), and Internal Operating Procedures (IOP). They will carry out the analytical review of QC analyses, LIMS authorization of analytical tests and QC release of raw materials, in-process controls, packaging materials, intermediates, and environmental tests

As a Senior Clinical Research Associate at ICON, you will work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II – IV, ensuring adherence to applicable regulations and principles of ICH-GCP. We pride ourselves on our supportive company culture, where we work as one team to achieve industry-leading results.

You will be involved in the submission of protocol, consent documents for ethics/IRB approval and assist in the preparation of regulatory submissions as requested.

You will be involved in the submission of protocol, consent documents for ethics/IRB approval and assist in the preparation of regulatory submissions as requested.

You will be involved in the submission of protocol, consent documents for ethics/IRB approval and assist in the preparation of regulatory submissions as requested.

Responsible for planning and coordinating assigned single, service standalone projects to ensure integration, coordination and consistency of processes throughout project life cycle. Ensure all budgetary requirements, study timeframes and targets are met for assigned projects. Provide project document management support to cross-functional teams by assisting in the administration, archive and tracking of essential documents of assigned projects.

Weﾠsupportﾠour CRAsﾠwith manageable sites & protocols, a strong benefits package that includes a comprehensive health plan, retirement plans, competitive pay, vacation, and eligible for the annual performance bonus. Additionally, we have cutting edge technology to ensure better outcomes.

This person will be providing testing support specializing in test script writing, execution, and documentation.ﾠ

The Chemistry Analyst I will work under direct supervision or be partnered with an experienced analyst to perform wet chemistry analyses, preparation of reagents, standardization of solutions, and instrumentation testing and documentation in a cGMP environment. May be cross-trained to work in other laboratory areas as dictated by the needs of the department.

This individual will play a key role in validating drug targets and running cellular assays using siRNA and small-molecule drug candidates.

Perform the functions and related tasks of antigen (native and recombinant) and monoclonal antibody production and other cell culture activities.

The person in this position will support a variety of programs that will require experience and/or the ability to pick up bench skills related to chemistry.

This position will have direct interaction with Manufacturing operations and Lifecycle Management group to support manufacturing sustaining activities. The position may have responsibility of Sustaining Quality support for more than one manufacturing area. Knowledge/experience with microarrays and DNA sequencing is preferred.

We are looking for a Associate Scientist 1 with experience in Chemistry, Biochemistry, and/or Materials Science to join the Chemistry and Materials group within Consumables Development Department. As a successful candidate you will work in a dynamic, team-oriented environment to create genomic analysis consumable devices that enable leading-edge medical research. You will be a key contributor within integrated and multidisciplinary teams developing new, and improving existing nucleic acid sequencing and sample preparation technology platforms.

As a Research Associate 1 at Illumina, you will work in a dynamic, collaborative environment and help the reagents/assay team in the development of core platform consumables to create cutting edge and robust new products. You will work in a fast-paced environment with multi-disciplinary teams, design and execute experiments, analyze data and communicate results and progress. Your work on reagent formulation, characterization, stability optimization and workflow development will enable project teams to make critical decisions during a product development cycle.

As a Research Associate 1 you will work in a dynamic, team-oriented environment and help improve genomic analysis tools used in cutting edge research. Working with Illumina’s Chemistry Development, Consumables, Software, Field, and Engineering teams, you will be responsible for investigating and resolving system level platform issues and supporting system verification and validation activities for planned platform changes.

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.

ImmunoGen is seeking an experienced and talented professional to join the department of Analytical & Pharmaceutical Sciences (APS) and play an important role in advancing ImmunoGenﾒs key development programs through both early and late-stage development with commercialization of our Antibody Drug Conjugates (ADCs). The Development Associate II will work with other internal developmental functionalities (e.g., Cell Line and Upstream Engineering, Process Science and Engineering, etc.) to perform high throughput purification and related analytical testings of development samples of therapeutical antibodies to advance various key developmental projects.

A successful candidate will enjoy working in a fast-paced environment and exhibit excellent interpersonal skills, the flexibility to adapt to changing priorities, and a firm scientific foundation to understand ongoing diagnostic R&D and associated studies.

Drug Safety Coordinator

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 preparation of autoimmune diagnostic Immunofluorescence Assay (IFA) slide, control and conjugate products in accordance with established procedures. Major duties include preparation activities for IFA controls and conjugates and the growth of cloned antigens in insect cells.

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.

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.

Sets-up and maintain Trial Master File (TMF) including project documentation files, investigator files, study books, and project databases on more complex projects

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

Assemble study designs, perform laboratory experiments, organize data, and analyze results under minimal supervision.

Formatting of documents, publishing, completing change control process; Document upload into training system and course creation.

The Research Associate, Screening Operations will be responsible for the execution of high throughput screens for microbial strain development. The candidate will have strong molecular/microbiology biology skills and familiarity with micro-cultivation of microorganisms. Practical experience using liquid handling robots and knowledge of biostatistics is preferred.

Perform in vivo assays and other bioassays in mice for validation of potential drug development targets and to characterize pharmacological compounds.

We are looking for a motivated and creative scientist to join our oligonucleotide/medicinal chemistry groups. Duties include production of synthetic oligonucleotides, equipment maintenance and troubleshooting of instrumentation. The successful candidate has the ability to complete assignments and meet deadlines and time schedules. May research and implement new methods and technologies to enhance operations. Other duties as assigned.

Perform a wide variety of routine and complex testing procedures to obtain data from client specimens. Provide documentation and review of work performed in a timely manner.

As a member of the Injury Surveillance and Analytics (ISA) Team, assist in data analytics, including data management, quality, and organization as well as project management of research related to sports injuries and player health. Responsibilities include contributions to development of study questions and substantive contributions to ad-hoc and scheduled reports (analysis and writing), data collection and management, creation of datasets using complex existing data sources, and ownership of client deliverables.ﾠ

The primary focus of the Manufacturing Associate role will be cellular therapeutic manufacturing at JuMP during process transfers, routine production, and technology improvements.

The primary focus of the QC Associate I/II role will be to perform GMP testing and environmental monitoring to support lot release and in-process testing.ﾠ

The primary focus of this role will be to purify and analyze recombinant proteins. Successful candidates will demonstrate understanding of basic biochemistry principals and working knowledge of protein purification and analysis. Demonstrated ability to follow protein purification protocols and deliver reagents under specified timelines is required.ﾠ

This individual will join an innovative, interdisciplinary team focused on the advancement of current analytical methods and maintaining a state-of-the-art flow cytometry facility. This individual will also be required to support colleagues in a cross-functional environment through the performance of routine analytical testing.

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.

Development of stable, clonal cell lines for the expression of therapeutic proteins; Technology development to improve productivity of cell lines/processes

Responsible for executing experimental protocols and performing elementary data analysis in biopharmaceutical development laboratories.

This individual will conduct cell culture and bioassays in support of product characterization and potency assessment. Requirements of the position include execution and documentation of experimental protocols, and assisting in the qualification and validation of methods.

This individual will utilize their experience in order to perform all testing consistent with established procedures and quality standards and processes within the laboratory.

The Quality Assurance (QA) Assistant supports all aspects of Quality Assurance within Kinovate Life Sciences (KLS) and provides routine Quality Systems oversight for processes and operations. The QA Assistant serves as a quality representative/point of contact in support of the day-to-day operations of all functional areas within KLS, including, but not limited to: Production, Quality Control, Material Incoming, Sampling, Shipping/Receiving, Order Fulfillment, Labeling, Packaging and Document Control.

This person will contribute to in vivo pharmacology efforts to support the advancement of our pre-clinical Oncology and Immuno-Oncology small and large molecule pipeline. We are looking for motivated and team-oriented individuals who want to contribute to our growing company.

This person will employ cutting-edge functional genomics technology to identify and validate novel targets in oncology and immuno-oncology.

Perform analytical testing of raw materials, in-process materials, stability samples, finished products and product development products using different analytical techniques.

Executes the activities of QC Microbiology Laboratory by following approved microbiological and chemical test procedures and ensure their delivery in an accurate and timely manner following proper safety precautions. Also provide QC microbiology support to the Aseptic Manufacturing and validation process.

Person exhibits aptitude in assisting in the development of topical product pharmaceutical formulations, as well as meeting timelines for the department.

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

LIS Coordinator, Laboratory Information Systems assists with test builds, utilizing the LabConnect system and partner laboratory LIMS. S/he performs duties associated with day-to-day tasks as assigned by Data Specialists.

his unique associate level position will be responsible for vendor contract coordination and various aspects regarding the procurement to payment process with our biopharmaceutical client. This position falls within business operations.

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

Assigns, oversees, and reviews the work of employees. Directs all phases of work, quality, service, and costs; and performs tests or assays as required.

Under supervision of licensed personnel, the Technician will assist with routine and specialty clinical laboratory testing responsibilities and provide general support for all aspects of the operation of the clinical laboratory while following established policies and procedures.

The Integrated Genetics Division is seeking a Cytogenetics Technologist or Technologist Trainee to join their Cytogenetics team in the Microarray Group! Assays performed in the Cytogenetics Department utilize a variety of scientific techniques, including specimen culturing, PCR, fragment analysis, and gel electrophoresis.

Provides leadership in the areas of quality assurance, quality control, quality related training, and standardization compliance within the laboratory. This position is also responsible for project management activities as they relate to identified areas within the laboratory requiring standardization to improve the quality and/or efficiency of operations.

The QC Technician will be responsible for reagent preparation and testing for use in a high throughput clinical testing laboratory. The Westborough molecular genetics laboratory provides high-throughput carrier screening and diagnostic testing for genetic conditions.

Provides leadership in the areas of quality assurance, quality control, quality related training, and standardization compliance within the laboratory. This position is also responsible for project management activities as they relate to identified areas within the laboratory requiring standardization to improve the quality and/or efficiency of operations.

The candidate will provide support to the Process Development group.

The candidate will provide support to the Process Development group.ﾠ

Perform Cell-based and Enzyme-based assays and related procedures using manual and automated liquid handling equipment

Seeking a highly motivated Research Associate I/II with a background in Molecular Biology to assist in the development of new technologies including CRISPR genome engineering and recombinant antibody generation. The successful candidate will be responsible for learning, researching and implementing recombinant DNA approaches to support research team needs, as well as designing work-flows, and assay developmen

To collect, process and package various abattoir sourced animal blood and/or tissues at the Coopersburg Lab and/or off-site abattoir/vendor locations as need to support production requirements.

The successful candidate will be responsible for learning, researching and implementing recombinant DNA approaches to support research team needs, as well as designing work-flows, and assay development.

Purification of normal, secondary antibodies, and custom mono and polyclonal antibodies with the goal of providing consistent, high quality products and services to our customers with complete, accurate documentation.

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

Provide planning and coordination support for the Hearing Conservation Research Program

The Research Assistant will work collaboratively with the full research team, including Principal Investigators, research scientists, data analysts and subject matter experts. Under direct supervision, this role will support a variety of research projects, including health promotion evaluations, clinical treatment interventions, and epidemiological investigations, designed to promote the behavioral and psychological health and readiness of military personnel and their families.

Responsible for supporting the Validation Engineers.

Applies process improvement, reengineering methodologies, and best practice principles to design and implement process modernization and improvements. Assists with analysis, evaluation, and assessment leading to development of recommendations for system and process improvements, optimization, development, and/or operations sustainment efforts for IT systems, software, and processes. Coordinates and manages analysis evaluations and quality assessments for proper implementation of programs, systems specifications, and quality standards. Establishes performance measures, monitors and analyzes performance metrics to identify and implement performance based improvements. Works closely with senior engineers/specialists or task leads.

The Drug Safety Specialist will be responsible for providing drug safety and pharmacovigilance support for ongoing clinical trials and marketed products across a variety of therapeutic areas and indications. This position will be responsible for the accurate and timely entry of safety data into the safety database.

Responsible for independent implementation of protocols, test scripts, documentation, process audits and test methodologies that ensure stringent testing of assigned reagents to achieve a quality reagent product. Requires strict documentation procedures, and good laboratory skills.ﾠ Will be required to compile and legibly document results in the form of a work instruction or report.ﾠ Requires strong interpersonal and technical skills to work effectively and efficiently with other departments to resolve problems and to achieve a quality reagent product that results in customer satisfaction. The QC Specialist I position requires experience in analytical methods used to test chemical material or biologics.

We are seeking individuals who are passionate about research, bring out of the box thinking and take bold steps to develop innovative technologies 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 and purification and cloning. Knowledge of the ubiquitin proteasome pathway is desired.

This position is responsible for the “front line” support of senior engineers involved in operating, maintaining and upgrading HVAC system used to support biotech manufacturing facilities. These systems will including air handlers, chillers, cooling towers, exhaust systems and the associated support and controls equipment. This position will interact with various team members on Process Teams, including Engineering, Facilities, Manufacturing, validation, and quality assurance and other Lilly Sites as required. Knowledge of HVAC and building management systems (BMS) or appropriate training is required.

Support leading the identification, evaluation and tracking of opportunities of interest, and maintain accurate records of activity through use of in-house caseload management information systems

Assist the Liquidia manufacturing team with various tasks and projects.

Performs Quality Control assays for Product Release and Stability Studies in compliance with Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). Being familiar with cell culture and cells assays. Skill set includes, but is not limited to flow cytometry.

Provide technical coverage and troubleshooting of plant processes;Improvement and optimization of existing operations