Links to 846 Entry-Level Biotechnology & Life Science Jobs

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

Performs testing and evaluation of hearing protectors and/or communications products in accordance with hearing protection industry standards and regulations, which includes working with human test subjects and acoustical manikins

Leads projects and programs to improve safety, environmental performance, productivity, and overall operational efficiency of the equipment using Lean Principles and Six Sigma Tools

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.

Formatting of documents, publishing, completing change control process;Document upload into training system and course creation;Annual document review including generation of list of documents due, issuing and tracking completion, document revision.

This 24-month rotational program is designed to train new Engineers on various aspects of MicroVention Terumo technology, procedures, and processes.ﾠ All candidates will be assigned a Mentor, as well as an Advisor to oversee their program succession, and will be provided with additional classroom training.ﾠﾠ

Performance of monitoring activities of all assigned clinical studies in accordance with regulations, SOPs and Good Clinical Practices guidelines: 

Under basic direction and supervision, the scope of this position is responsible for addressing customer calls and emails relating to product inquiries, opinions/suggestions and complaints concerning a variety of the company's products, using professional concepts, technical knowledge, and company’s strategies, tactics, and policies and procedures formulated in association with management, with the objective of satisfactorily addressing the customer's inquiry or complaint.

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. 

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.

Conduct quality-related activities to deliver consistent,high quality documents,services,products and processes.

Completes assigned daily activities; workload; scheduling; and constraints independently. Provides technical expertise to complex projects / product and investigations as required. Strives to become the technical expert within work area.

Provide Process/Quality Engineering support on quality system improvements.  Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. 

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

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.

The primary responsibilities of this position include 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, cell-based functional assays, and general lab maintenance.  

The Manufacturing Associate performs routine and complex operations for the GMP production of pharmaceutical products. This individual operates in accordance with environmental, health, safety, and cGMP guidelines.  This individual is responsible for the hands on execution of production activities as they relate to spray drying, capsule filling, and blister packaging operations of manufactured products.

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).

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.

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

The Regulatory Affairs Specialist  supports the creation, revision and review of various documents associated with clinical research and meeting the regulatory requirements of US Food and Drug Administration (FDA) and other international and regional governing bodies and Health Authorities (HAs). The documents may be submitted to support clinical development, registration, and regulatory compliance of Aerie’s drug products, worldwide. This position supports also Aerie’s post marketing pharmacovigilance (PVG) and promotional activities, as needed.

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 Quality Specialist II is accountable for driving results in a fast-paced environment by effectively performing activities of some variety and complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting basic floor audits and processes inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The Quality Specialist II assists with the development of SOPs or other quality documents as needed. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

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.

The Development Associate I is responsible for performing assigned experimental tasks to support the development and optimization downstream purification processes for Alexion’s biotherapeutic molecules and will be expected to accurately follow written procedures and contribute to laboratory tasks under supervision.   The Development Associate I will collaborate regularly with scientific staff in other Research & Development groups.

 This person will be involved in establishing, validating, and implementing methodologies in Alkahest’s laboratories and is thus pivotal to the company’s mission. 

This position will be responsible for the characterization of enzymes expressed in mammalian and prokaryotic cell systems.  This resource will apply a wide knowledge of protein quantitation and analysis techniques both in vitro and in cell-based models, especially related to enzymology, to characterize protein products. This position will share responsibility for propagation of prokaryotic and mammalian cell lines and purification of enzyme products using established protocols.

Candidate will assist with assigned tasks such as method development, transfer and validation; provide analytical support to the research and development group to meet project goals; select appropriate methods and techniques in performing experiments; collaborate with analytical personnel to help develop routine analytical methods; work cross functionally to achieve target goals and proactively seek out potential solutions to issues.

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.

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.

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.

We are seeking an energetic and driven Stem Cell Research Associate to join our team to design and implement cell and molecular biology laboratory research in the lab and work directly with preclinical disease models.

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.

Learn techniques spanning across the entire spectrum of analytical chemistry from wet chemistry to HPLC, NMR, Mass Spectrometry, FTIR, GC and GC-MS.

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.

Effectively contribute solid technical knowledge to a variety of projects related to process development with minimal assistance.Display basic technical understanding of process development.Conduct routine/non-routine research and design experiments with minimal assistance.

Responsible for designing, developing, implementing and evaluating optimal, cost-effective projects and technologies. In addition to providing technical support and service to these areas, the incumbent may also perform the following functions: supervising, requisitioning, defining, initiating, specifying, documenting and training.

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.

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

We seek a protein biochemist who will contribute to the ongoing research and development of products including complex assay systems, post-translationally modified proteins and peptides, and recombinant enzymes. The successful candidate will have previous

This is a fast-growing life sciences location focused on transforming cell separation and cell therapy manufacturing workflows though our disruptive QuickGelTMtechnology. This Research Associate position will provide technical and logistical support for o

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

Support Clinical Trial Manager (CTM) in preparing and/or reviewing study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines).

The right candidate will support activities associated with compliance to FDA regulations and policy, and HIPAA requirements as well as other associated regulatory concerns. You’ll be part of a dynamic team that functions cohesively to ensure that all reg

Develop and optimize protocols for T cell gene editing, including: megaTAL delivery methods, culture conditions, scale up, and multiplexing

The candidate will have the opportunity participate in development, scale-up, and manufacturing. We seek candidates with proven ability to successfully work independently and collaboratively across functions to meet aggressive project timelines, with the ultimate goal to deliver therapies that transform the lives of patients.

Aid in performing general lab maintenance activities including material inventory management, tubing/labware preparation and autoclaving, as well as overall lab cleanliness.

Data Entry Associate will enter clinical research data into a clinical trial management system(s). The work is transcribed both from paper documents as well as from an electronic system. Data Entry Associates assist Clinical Data Management team in all tasks related to study start up to closure.

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 Cell Culture or Purification as assigned related to the manufacturing of bulk drug substance in a multi-product facility. This may include tank or bioreactor CIP/SIP, cell inoculation and transfer, harvest, chromatography, and tangential flow filtration. Performs duties under limited supervision and according to standard operating and manufacturing procedures.

The Quality Assurance Specialist supports the QA Lead and the company’s quality program by auditing chemists analytical data, routine work, protocols and reports.

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).

This position is responsible for process improvements (i.e. LEAN) and validation of Vascular Graft and covered Stent Graft manufacturing processes. This position is also responsible for the transfer of newly developed products to manufacturing.

The position of Regulatory Affairs Specialist is responsible for the development and support of China FDA product registrations with International Business Center (IBC) contacts in China. The candidate requires a working knowledge of the products and relevant Chinese regulations and guidance documents.

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.

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

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.

A Veterinary Assistant is responsible for: providing animal care and welfare compliance in the form of basic medical treatments and emergency response as directed by staff veterinarians; assisting the veterinary staff in general husbandry oversight of all laboratory animals in accordance with Institutional Animal Care and Use Committee (IACUC) policies, and animal welfare standards and regulations by Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), United States Department of Agriculture (USDA), and Public Health Service – Office of Laboratory Animal Welfare (PSH-OLAW); and performing assigned basic technical and administrative functions within the guidelines/requirements outlined in a protocol or Standard Operation Procedure (SOP) in order to support the evaluation of a test article.

The Formulations Technician will prepare routine test article/substance dosage solutions and/or suspensions in accordance with Standard Operating Procedure (SOP) and Good Laboratory Practice (GLP) guidelines under direct supervision, and may serve as primary technician on studies that tend to be routine, less complex studies.  In a typical day, you will perform standardized preparation procedures and calculations, ensure record keeping is consistent and correct, complete documentation for the use of all test articles and vehicles/reagents to ensure consistency and correctness, and receive incoming test articles/substances and reagents.  You will also be expected to ensure formulations samples are collected, packaged, and shipped properly and on time, as well as ensure the test articles from assigned completed studies are returned to the sponsor or reassigned to another protocol.  Additionally, you will respond to Quality Assurance (QA) audits of preparation procedures and calculations on assigned studies, ensure data sheets are complete and submit them for review, assist in reviewing data, prepare labels and samples, maintain cleanliness and general appearance of the laboratory, ensure the laboratory is stocked and assist in maintaining current inventory of reagents, test articles, vehicles, and samples, utilize appropriate Quality Control (QC) procedures/measures to help verify the accuracy and correctness of data prior to submission to internal QA, and perform all other related duties as assigned.

Responsible for performing a wide variety of tasks involved in sample processing and inventory management of critical components, critical laboratory supplies, specialty reagents, client-supplied raw materials and internal and external cell banks. Performs activities related to log in, sample processing, storage, shipping of stored materials and client support.

Under direct supervision, responsible for performing basic daily laboratory and clean room tasks as they relate to the operations performed within the Microbial Cell Banking group of the Manufacturing department.

Assist scientific staff by working under general guidance/supervision on basic scientific support, report development, regulatory compliance, and research.

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

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.

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.

The successful candidate will be an experienced chemist with state of art knowledge of synthetic organic chemistry, and will be a motivated, creative, hands-on laboratory scientist with the ability to interact effectively with team members and external customers.

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

Primary responsibilities include conducting disease tolerance and screening assays on various crop species from the laboratory research environment to growth-chamber/greenhouse research environment.

The position will help to run and maintain an automated platform supporting Cibus’ patented RTDS™ gene editing technology. The successful applicant will be expected to assist with all aspects of the automated workflow including maintaining plant cell cultures, operating a robotic system, and data mining and analysis. Responsibilities will involve initiating experiments, sample monitoring and management, image analysis, running and troubleshooting the automation platform, data retrieval, processing, analysis and reporting. 

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 Pharmacovigilance Specialist (PVS) primary responsibility is SAE case management. This includes but is not limited to: initial case disposition, confirmation of case disposition with Medical Monitor (MM)/Safety Physician PV (SP PV), MM, receipt of adverse event data, data entry, source document data extraction, draft narrative development, follow-up management and reporting according to regulatory requirements.

To be successful in this role, you’ll be able to efficiently maintain the document control portion of Cochlear Americas’ standard operating procedures (SOPs) and marketing submissions in MasterControl. You’ll work collaboratively across various departments to create, maintain, and update job title specific training matrices along with Cochlear employee infocards. Additionally, you will be responsible for document retrieval, monitoring delinquent training assignments, and reporting on document control metrics.

The positions will focus on implementing and utilizing state-of-the art automation, analytical and preparative scale chromatographic systems to deliver high quality compounds for drug discovery in the first in-class Automated Life Sciences Studio facility located in La Jolla, CA.  

 The successful candidate will be responsible for developing and executing standard work procedures on a wide range of molecular biology techniques related to Next Generation Sequencing

We are currently seeking a scientist to support projects related to metabolic engineering of plant and microbial secondary metabolites. This position will focus on microbial metabolic engineering and the candidate is expected to have a strong background in metabolic engineering, molecular biology, genetics, and ideally synthetic biology. Strong technical, organizational, and communication skills are essential.

This position will focus on microbial metabolic engineering and the candidate is expected to have a strong background in metabolic engineering, molecular biology, genetics, and ideally synthetic biology. Strong technical, organizational, and communication skills are essential.

The Quality Engineer New Product Development (NPD) is responsible for supporting all quality engineering activities to support the new product life cycle, from concept through commercialization and sustaining changes, as part of a cross-functional development team.ﾠ Serves as the key resource for ensuring compliance to ISO, MDD and QSR requirements for Medical Devices. Takes the lead with quality initiatives with inter-organizational impact following QSR, ConMed Policies and standards. Works under direction from Quality Management.

This position involves using the latest single-cell technologies to screen for chromosomal abnormalities via next generation sequencing.

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.

The Manufacturing Associate is an enthusiastic, self-motivated person with great communication skills who can support Manufacturing and Clinical Operations through the manufacture and quality control testing of in house prepared reagents.  As a Manufacturing Associate you will be heavily involved in the manufacture and testing of bulk reagents and assay plates.

As a Study Technician (Research Assistant) - Pathology, you will perform basic necropsy or histology tasks on a variety of laboratory models. While ensuring compliance with the appropriate SOPs, GLPs, and regulatory guidelines, 

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.

The Quality Specialist I, Supplier Quality is responsible for performing a wide variety of Supplier Quality activities to ensure compliance with applicable regulatory requirements.

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’s design description to meet business requirements and technical specifications

We are looking for an Assistant Scientist to join our Product Chemistry group. This position is responsible for conducting analysis and experimentation on substances in the laboratory with minimal supervision and using prescribed procedures (protocols, standard operating procedures, methods, etc.).  Completes work for research and development, CGMP and/or GLP studies, and documents and reports data in a timely manner according to regulatory guidelines. 

The Associate Scientist conducts analysis and experimentation on substances in the laboratory with minimal supervision and using prescribed procedures (protocols, standard operating procedures, methods, etc.).  Completes work for research and development, and GLP studies, and documents and reports data in a timely manner according to regulatory guidelines. 

EAG Laboratories is looking for an Associate Scientist to join our fast growing Biotech team which provides a comprehensive range of biopharmaceutical services from analytical physic-chemical characterization to routine release and stability testing utilizing well-established techniques including HPLC, capillary electrophoresis, light scattering, ELISA, cell bioassays and mass spectrometry.

We are seeking a Clinical Operations Associate (COA) with a keen attention to detail who can both prioritize and handle multiple tasks effectively in a fast-paced Research and Development (R&D) environment.  The COA is responsible for assisting the study team in running the day to day operational activities of clinical studies.  Under the guidance of Clinical Operations management, the individual will coordinate, track, and manage daily activities for multiple clinical studies to support both the internal project team and the CROs. 

The successful candidate will work as part of a team to aid in developing novel CRISPR/Cas9 technologies to be used as therapeutics. This stimulating role will be in exploratory CRISPR/Cas9 platform development in an entrepreneurial and fast-paced environment. The successful candidate will have strong stem cell culture experience and molecular biology skills and be able to independently design and interpret results. The position requires flexibility, creativity, and the ability to work effectively in a multi-disciplinary team, as well as excellent written and verbal communication skills, and a capacity for creativity and innovation to achieve company goals.

This person will be responsible for supporting supplier quality vendor management, audits, and improvements while supporting continued Quality System improvements. In this position you will support activities sustaining quality engineering within Receiving Inspection, Manufacturing, and Product Verification as applied to supplier related issues.

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. Please refer to the job description for additional details.

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

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.

Provide oversight and support of document and records management in Document Control using company procedures and regulations.  Provide support for Global Document Management System project (Veeva).

Provide support in research and development efforts for novel analytical models combining multi-modal physiological data

With assistance from senior scientists or management, this position is responsible for protein and/or antibody production, purification of recombinant proteins and/or antibodies, and testing product specificity and quality through variety techniques including, but not limited to SDS-PAGE electrophoresis, Western Blotting, enzyme-immunoassays and cell-based assays. As part of manufacturing team, this position will share matrixed responsibilities with team members to meet reagent production goals.

Thorough understanding of cGMPs, specifically as they apply to a Pharmaceutical environment.Experience testing raw materials (API/Excipients), in-process, finished product and stability samples.

Performing physical, chemical, and instrumental analysis of active pharmaceutical ingredients and finished pharmaceutical products (tablets, capsules, parenterals, devices, liquids, creams, and gels) and animal health products

Routine testing to support analytical laboratory; Using multiple analytical methods including HPLC, Spectrophotometer, analytics, pH, raw materials.

The Associate Scientist II will support the Discovery Services and Products Team in contract research services. This role requires knowledge of scientific principles and experience in a general lab setting.

This position is responsible for supporting the development of complex parenteral formulations and their associated manufacturing processes through the design and execution of research and development activities and analysis, interpretation, and communication of process, analytical, and/or pharmacokinetic data, results, and conclusions.

The Clinical Lab Scientist (CLS) will work in Flow Cytometry area and performs testing. Performs and document quality control and preventive maintenance. Follow good laboratory practices and procedures for compliance.

The Clinical Supply Specialist is responsible for supporting multiple clinical programs working closely with the Clinical Supplies project leads. The selected candidate will independently coordinate clinical supply activities for clinical studies in support of development programs.  The activities include review of clinical study protocols, design of clinical labels, preparation of packaging and labeling requests, management of depot and site shipments, monitoring study drug inventory levels, and assist in supply planning and forecasting.

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.

To perform laboratory QC Microbiological testing for in-process and finished product, water sampling testing, and routine and batch processing environmental monitoring in aseptic classified cleanrooms.

Research Technician I, with guidance from the Research Operations Core Manager, will perform Core Lab Methods to support data generation across all research programs.

 The successful candidate will be responsible for learning and implementing the operation, maintenance, and optimization of Five Prime’s automated high-throughput protein expression system as a member of a cross-functional team supporting early target discovery efforts within Research.  The candidate must be self-motivated, detail oriented and thorough, and capable of working both independently and in a team environment. 

As a Manufacturing Engineer with Fluke Electronics you will be tasked with analyzing, developing, implementing and maintaining methods, manufacturing operation sequences, specifications, and equipment requirements for production/assembly of new and existing products. Assist new product introduction to manufacturing and released product support. Through these activities metrics will improve in such areas as safety, quality, cost, and productivity to name a few.

The Laboratory Assistant will be responsible for laboratory documentation and quality control activities in the Accessioning, Histology and IHC laboratories.   Data verification will be performed both on paper documentation and in LIMS and other computer systems. The assistant will also be responsible for performing miscellaneous laboratory duties

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.

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.

 The Downstream Manufacturing Technician III will work directly with a range of purification technologies including: filtration technologies (TFF and depth), chromatographic separations (Single Use GE AKTA systems), viral inactivation following aseptic techniques and procedures in a cGMP environment.

The Downstream Manufacturing Technician III will work directly with a range of purification technologies including: filtration technologies (TFF and depth), chromatographic separations (Single Use GE AKTA systems), viral inactivation following aseptic techniques and procedures in a cGMP environment.

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.

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness.  Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer.  Performs media/buffer solution preparation operations.  Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).  Responsible for being proficient in one functional area.  Understands and applies biological, chemical and mechanical principles and techniques.

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

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

GigaGen seeks a talented, highly motivated Research Assistant to work alongside PhD-level scientists on research funded by a $50 million co-development deal with Grifols, plus Phase II SBIR grants from the NCI and NIAID. 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.

Works with staff from other functional areas to meet complex project deliverables such as new product launches or start-up of new manufacturing/packaging sites.

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.

In this role, you will support medical-device manufacturing operations, drive improvement projects, and partner with manufacturing and engineering teams to manage projects and execute on initiatives that support key business priorities. You will build influential relationships with manufacturing teams across multiple shifts, establishing a strong partnership with all manufacturing support functions, including engineering, planning, internal suppliers, quality assurance, maintenance, health and safety, and finance. You will also collaborate with other industrial engineers across the organization to share best practices and establish IE functional excellence.

The Process Monitoring Associate will assist in monitoring Clinical Lab assay activities to sustain high quality data generation and resolution of production assay issues. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multi-task, be flexible with tasks and schedules, and the ability to work independently in a team environment.

The Research Associate will be an integral part of the Research Department. The successful candidate will be expected to perform research studies and prepare scientific reports to support pre-IND and IND activities.

Responsible for equipment setup and operation in a biologics processing environment for plasma derived pharmaceuticals

The incumbent is responsible for performing complex laboratory analysis of plasma and plasma products in a GMP laboratory. Responsibilities include sample accessioning, sample preparation, reagent preparation, testing, result calculation, as well as quality control of assays and equipment.ﾠ

Performs chemical testing of moderate to advanced complexity within a Quality Operations Laboratory in a safe, accurate, and efficient manner following established written procedures while maintaining complete and accurate records of the work and results. This testing is required for the release of raw materials, in-process materials, and final containers.ﾠ

Mechanical and utility system operational authority for the biopharmaceutical process facility. Plans and implements the operation, modifications to, and maintenance of mechanical and utility systems (HVAC, Boilers, Chillers, Cooling Towers, Purified Water Systems, Compressed Air/Gas, CIP Skids) and their distribution.  Also responsible for the maintenance and improvement of broader site architecture and facilities.

This individual will plan and implement efficient synthetic routes to complex molecules of interest both independently and under guidance, applying state of the art purification, and characterization techniques for lead optimization and SAR generation. 

This role will provide technical expertise within the Formulation, Filling and Lyophilization value stream, to lead troubleshooting exercises and implement continuous improvement projects to achieve business objectives for supply, quality, EHS and cost.

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.ﾠ

This position is responsible for the evaluation of human blood products for manual or automated cell isolations, product manufacturer, and cell culture. Perform QC testing and create a certificate of analysis (COA) for products manufactured. Record isolation details on a processing worksheet using good documentation practices. Operate flow cytometer and basic lab equipment.

Supports the conduct of research studies at the clinical research center The Clinical Research Coordinator (CRC)ﾒs primary responsibility is the protection of subject safety. The CRC is the client liaison to the internal and external operational teams ensuring that studies are conducted in compliance the protocol, ICH and GxP.

Perform functions of the Chemistry Laboratory and conduct chemical and physical analyses on pharmaceutical products through all stages of the manufacturing process from incoming components and raw materials to finished goods and stability. Execute process and cleaning validation and/or test method validation under the direction of supervision. Write/revise standard operating procedures, forms and exception reports. The duties also include equipment maintenance and LIMS management

As an Engineer I in the Manufacturing Engineering Department you will support several manufacturing assembly lines within the Final Assembly Dept.  You will partner with cross-functional operations team members (i.e. Production Supervisor, Quality Assurance Engineer, and Materials Planning) to effectively identify, investigate and resolve manufacturing process related issues. In addition, you will drive continuous improvement initiatives in support of departmental, site and corporate objectives for Safety, Quality, Delivery, Productivity, and Cost performance.

The Analytical Chemist will provide analytical support to all projects guaranteeing that development analytical tasks are accomplished within the time frame defined and according with the scope and GMP requirements.

The Quality Control Analyst will be responsible for carrying out analytical testing on Raw Materials, In-Process Materials and Finished Products; and for providing technical support as required by management.

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.

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.

The Medical Technologist in the Molecular Lab will perform genetic and molecular biology laboratory procedures involving traditional techniques such as PBMC, isolation of DNA and RNA, PCR, RT-PCR, Real-Time PCR, and other molecular techniques (knowledge of Illumina MiseqDx NGS and Luminex 200 are strongly desired). 

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

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.

The Equipment Engineer I will be responsible for integration, implementation, service and maintenance of laboratory equipment. This will include automation and instrumentation in support of a Clinical, Research and various GxP Laboratories.  This includes installation, configuration and repair of equipment, integrating equipment with information systems and validation and verification of the equipment in accordance with CLIA, cGMP and/or GLP guidelines. Responsible for preparing maintenance and operation protocols for licensed Clinical Laboratory Scientist review while following the manufacturers and the Equipment Quality system documents. The Equipment Engineer will trouble-shoot problems with equipment and conduct or coordinate required repairs and complex maintenance tasks.  The Equipment Engineer will provide input regarding the selection of new equipment and support of new processes as it pertains to the site infrastructure.

This position is responsible for Supplier Quality activities that improve, monitor and measure Illumina’s compliance with the Quality System Regulations, Illumina Quality policies, FDA regulations and ISO standards as well as Illumina product quality for current operation and compliance objectives.

As an Associate Scientist within Illumina’s Clinical Genomics Product Development organization, you will work as part of a multi-disciplinary team to ensure clinical products meet their stated claims, continuously meet global regulatory standards, meet customers’ expectations, and remain competitive in the markets they serve.

We are looking for a highly motivated Production Technician with experience working in chemical or biological laboratories. Technician will assist Manufacturing team in production of medical devices. Successful candidate will work within a high-energy, small, focused team environment and maintain a strong sense of shared responsibility and shared reward to make work fun and interesting

The Cell Culture Technologist, Upstream Process and Manufacturing Sciences is responsible for participating in the operation of mammalian cell culture processes under cGLP conditions.

The QC Analyst performs routine sampling, testing, and data reporting and performs support activities such as purchasing, receiving, and general laboratory maintenance as assigned by management. May coordinate with external suppliers of testing services.

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 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

The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.

The position will support improvements of existing products as part of the design change process, support supply chain concerns as well as design related aspects of product and process transfers between manufacturing sites.  This position will have responsibility for executing base business design change projects to ensure the highest levels of product quality to the end customer. 

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.

Responsible for executing assigned experiments and tasks to support the development of Intuity Medical new blood glucose monitoring system.  Under the direction of senior staff, the chemistry technician works independently and within cross-functional teams to carry out project tasks related to reagent formulation, method development and validation, feasibility study, material evaluation, selection and validation, stability study as well as performance testing of built cartridges and meters.

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 candidate will be a member of the Cell Sciences team working to support Junoﾒs expression function.ﾠ The job will require the candidate to play different roles within the group, as need dictates.ﾠ The focus will be on establishing and maintaining expression cell lines, with the objective of supplying research groups with critical reagents.ﾠﾠ

This entry-level role allows for development within Validation and the Manufacturing Sciences organization, and is initially responsible for the execution of equipment qualification (IQ/OQ/PQ, requalification) protocols and completing execution summary reports with high quality and timely output.ﾠ This role will be exposed to all facets of Validation at Juno Therapeutics and the Associateﾒs scope of responsibilities is expected to grow over time as their skills develop.ﾠ This role reports through site GMP Validation.

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.

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.

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

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.

The Junior Engineer will support ground transportation-related work for contracts with the U.S. Department of Transportation (U.S. DOT), State Departments of Transportation (DOTs), and the National Highway Traffic Safety Administration (NHTSA).ﾠ

rovide subject matter expertise in workgroups for replacement of customer systems Interface e.g. (Sensaphone, Computerized Maintenance Management System, and Ventilators) and perform as the strategic liaison with the appointed representative within Program for the development of the management tool for the accountability of Maintenance tools and systems.ﾠ Provide research and analysis with vendors, site personnel, customer IT Support, customer Quality Control Unit, customer Team Room, and customer Leadership that manages the Chemical Package program.

The selectee will, under the leadership of Senior Personnel, provide technical expertise to aid the Government in the overall certification of cryptographic products for ground/airborne/satellite communications including those making up Space Systems of Systems, a collection of task-oriented or dedicated systems creating more security functionality than the individual components

Independently develop protocols, applications, and products. Identify product opportunities consistent with corporate goals. Independently plan and execute experiments, and review results with supervisor. Write reports, technical documents, and application notes. Develop synthetic routes and analytical methods. Perform syntheses and purifications at bench scale (milligram to kilogram) of chemical products for Research and Development, clinical trials and commercial use. Analyze compounds produced and maintain documentation of experimental results. Prepare and present scientific posters at national meetings. Mentor others in the group. Keep laboratory notebooks, attend project and group meetings, and perform other job-related duties as required.

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.

Your role will include design and execution of mRNA and/or yeast library selections that should result in discovery of clinical drug candidates. You will also be responsible for designing and implementing novel chemical reactions that can be incorporated in mRNA library design. One of your main responsibilities will include evolving the current display/panning practices towards innovative functional-based selection processes. 

This position is responsible for the “front line” support of senior engineers involved in operating, maintaining and upgrading critical utility system used to support biotech manufacturing facilities. These systems will include purified water, water for injection, clean steam, clean dry, air and other systems as required in the manufacturing process.

The Scientist I position will perform a variety of tasks in support of all Process Development activities.

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

The Manufacturing Assembly Associate II is responsible for the building of plastic parts into a medical device cassette for use by Engineering R&D, Clinical Studies and Product Sales.ﾠTheﾠ process of building may be done manually with simple tools, fixtures and/or automated equipment.ﾠAny process control points will be processed similarly to the build process.ﾠAdditionally, this position involves the maintenance and/or calibration of equipment used for the manufacturing of product under the company quality system.ﾠ

The responsibilities for this position will include preparing and analyzing formulations to characterize drug substances and prototype drug products. Analysis includes characterization of physical and chemical properties, including but not limited to evaluation using HPLC and aerodynamic particle size distribution.

Key individual contributor in the development of next generation sensors/tools and improvement in existing products/tools

Perform histology tasks such as embedding, cutting, staining, and cover-slipping of slides for microscopic examination.

Test API and final drug substance and drug product according to written procedures following cGMP practices

You will be responsible for assuring the quality of commercial and clinical products manufactured at the facility.ﾠ

The successful candidate will carry out analytical testing and method development using Electrophoresis, Chromatography, and Mass Spectrometry techniques in support of early and late stage development of biopharmaceutical products, such as humanized monoclonal antibodies, and recombinant proteins. The candidate will make detailed experimental observations, review and analyze data, interpret experimental results, and summarize data for presentations and reports. The candidate will author SOPs, protocols, reports and other relevant documentation.

This position provides industrial engineering support for New Product Development initiatives in Medtronic’s Surgical Innovations business unit.  This role will support the portfolio of Surgical Innovations projects being led by the R&D centers in North Haven, Shanghai, Woburn, and Trevoux.  Team is focused on creating innovative analytic solutions & data visualization to influence and drive sound business decisions related to product life-cycle management, manufacturing strategy, and extended value stream capacity planning. 

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

The Associate PMV Analyst is responsible for monitoring, tracking, and trending product complaints in order to assure compliance with worldwide regulations and standards.  Duties include intake and closure of complaint files and in-depth trend analysis. The candidate must have excellent customer service skills, an analytical mind, and the ability to evaluate and disseminate information from a global perspective.  This entry level position requires and eye for detail and excellent organizational skills.

This position has the responsibility to perform Quality Engineering functions including inspection and testing, procedure writing, statistical analysis of quality data, supplier qualification and performance monitoring and reviewing and approving design changes,

Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.

The Associate Manufacturing Engineer is responsible for the evaluation, analysis, and implementation of projects driving cost reduction of manufacturing processes that provide implantable components to finished devices. This position interacts closely with the Operations team as well as several engineering disciplines such as Process Development, Quality, Reliability Engineering, and Regulatory Affairs.  Additionally, this position requires problem solving skills and technical knowledge (Lean, DMAIC) and the ability to manage complex projects to a successful and timely conclusion. 

This position will be primarily responsible for supporting the development, documentation, maintenance and improvement of the site Quality Management System.  This position will work closely with Quality Systems leadership (Process Area Leads) and Subject Matter Experts (Process Owners) to ensure the Quality System and processes are efficient, and compliant to internal and external requirements.

The Medical Writer [Bilingual - Chinese (Cantonese/Mandarin) and English] role in our Medical Affairs organization supports the Global Neurovascular business unit. The bilingual (Chinese/English) Medical Writer will be focused on developing clinical, scientific, and regulatory documents for the China FDA along with some responsibilities for other global markets.

In this exciting roleﾠSupplier Quality Engineer, you will have responsibility forﾠsupplier management activity working with external suppliers and internal teams to assure that our products exceed the requirements and expectations of patients, physicians, regulatory agencies and the business.

Serve as Clinical Affairs representative on assigned project teams and/or PDP teams to develop clinical strategies that support corporate and departmental objectives. Provide clinical and technical feedback to product development teams during project team meetings.ﾠ

This position will be responsible for developing test methodology to conduct material, component and device level testing to ensure products meet specifications and regulatory requirements. The engineer will conduct verification and validation activities inclusive of creating protocols, testing per approved protocols, and documentation activities in accordance with applicable development and regulatory requirements. The engineer will collaborate with design colleagues to ensure designs are capable of meeting performance targets while supporting multiple projects within the product development group.

ﾠCoordinate activities related to safety assessment, report management, safety committees, system and process development, policy review and implementation, and management review.ﾠ Contribute to accurate and timely reports for study teams and management, including resolution of action items.ﾠ Maintain documentation consistent with Medtronic standards, guidelines and policies. Execute continuous improvement projects, perform other duties and ad hoc projects as assigned in support of the Clinical Research department.ﾠﾠ

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

Manufacture or evaluate products according to established protocols, provide technical support to others and perform operations in support of the group and department.

Your primary area of focus would be to perform extractions and then subsequent NVR, TOC, FTIR, and RP-HPLC testing and peer review for Extractables and Leachables studies in a GMP environment.ﾠ A secondary area of focus will be on assisting with sample preparations and performing lab maintenance activities such as glassware cleaning, hazardous waste disposal, and order receipt.

Kilo Lab and Pilot Plant manufacturing of APIs and intermediates;Demonstrate proper lab safety practices, and work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines.

Manufacture or evaluate products according to established protocols, provide technical support to others and perform operations in support of the group and department.

Position primarily involves the safe and efficient manufacturing of APIﾒs according to cGMP requirements.

The Associate Scientist will contribute to the achievement of drug discovery project goals through the synthesis of target molecules by applying modern organic synthetic methods and following best medicinal chemistry practicesﾠ

The successful candidate will primarily work with in vivo tumor models and be responsible for validating the in vivo pharmacology and therapeutic utility of novel mRNA therapeutics.ﾠ Applicants should be great team members and have a track record of independent research accomplishments.

The primary responsibilities for the Research Associate, Process Development will be to support the Process Development team to develop and scale-up messenger RNA therapeutics. The scientist/engineer will be involved in clinical study enabling scale-up and pilot production of mRNA. The position will partner closely with Process Sciences and Production teams, and the candidate must be able to work in a multi-disciplinary environment.

Reporting to the Senior Manager of Quality Control, the Quality Control Stability Associate will be responsible for supporting GMP stability testing programs and Quality Systems, including the maintaining of stability databases, performing data trending and statistical analyses, creation and review of SOPﾒs, stability protocols and reports in accordance with current GMP, FDA, EU and ICH guidelines and regulations. This individual will also support the implementation and functionality of stability related processes, equipment and systems at both the Cambridge, MA and Norwood, MA locations.

The individual in this role will be part of a cohesive team responsible for producing high quality mRNA-based medicines for evaluation in human clinical trials.ﾠ The Manufacturing Support Specialist team member uses knowledge of cGMP regulations and biopharmaceutical production processes to assist in investigations, document generation and improvement initiatives within manufacturing operations or other departments as needed. They will work directly with subject matter experts to ensure content accuracy, improve efficiency and documentation practices.

This position is part of Modernaﾒs Manufacturing Science and Technology (MST) team responsible for ensuring the robust technology transfer and technical support of our mRNA platform in cGMP Manufacturing.ﾠ The individual will work closely within MST, and with Process Development, Manufacturing, Regulatory, and Quality, to ensure all aspects of technology transfer and technical support are successfully executed.

This position is responsible for following established methods to quantify chemical entities according to applicable Standard Operating Procedures (SOPs) and/or GxP regulations. This individual 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 communicating effectively with others. initiatives, and demonstrates

This position is responsible for performing the technical functions in necropsy including the handling and euthanize of multiple species of animals, collection of tissue and blood samples, and the proper preservations of specimens, as well as for performing technical support functions, as necessary. It is expected 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 is responsible for performing assigned basic support functions in the Clinical Pathology Laboratory setting. Functions include Set-up, Processing, Sample Management, and/or administrative functions as outlined in a protocol or appropriate Standard Operating Procedures (SOPs).

The successful candidate will join a team of researchers actively conducting genomics-based research in infectious disease diagnostics, bio-surveillance, microbiology, virology, and microbial forensics for a variety of government and industrial clients.

Work with pharmacology colleagues to gain an understanding of primary and secondary pharmacology mechanisms, biomarkers, translational potential, and safety for discovery- and development-stage programs

The Manufacturing Research Associate I is responsible for supporting the production of reagents used in nCounter Analysis Systems. The role requires learning and performing both manual and automated production processes for the manufacture of raw, intermediate, and final reagents needed for the multiplexed detection and quantification of many different types of target molecules from biological samples.

TheﾠResearch Associateﾠ(Cell Culture Technician)ﾠwill assist scientist/senior research associate for the culturing, plating, distribution, maintenance, and banking of cell culture lines. Important aspects of this role include excellent organization skills, flexibility, and the ability to thrive in an efficient, highly interactive, goal-oriented team environment, and working with minimal supervision.

Clinical Laboratory Associate I to analyze laboratory specimens following the standard methods and procedures while maintaining equipment and instruments in good operating condition by troubleshooting malfunctions as needed.

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

Perform molecular biology assays such as PCR, HRMA, Restriction Enzyme digestion, and gel electrophoresis.

You will be reporting to the Transgenics Supervisor working among a team,ﾠto deliver custom transgenics to our clients, in a timely manner, using established procedures. ﾠThe sophisticated nature of the work requires attention to detail and high-functioning knowledge of current genetic techniques. The ability to work independently according to schedule is balanced with the need to collaborate extensively with colleagues to ensure that we consistently meet or exceed our clientsﾒ expectations.

The main responsibility will be to setup a quality control program and testing for products and materials. Other responsibilities include but are not limited to, calculating and summarizing data using scientific equations, set up and perform studies on components, record test results on standardized forms and write reports detailing procedures, file and maintain retention storage of all product components and reagents.

Lateral Flow Chemist

Perform microbiology department related tests according to USP methods and established procedures that follow cGMP guidelines and demonstrate outstanding aseptic techniques.

This is a highly dynamic role with responsibility to support programs across NGMﾒs research and development portfolio.ﾠ

Responsibilities include implementing regulatory plans, completing regulatory deliverables for medical devices and supporting customers with product registrations. ﾠ

Perform micro/EM testing such as environmental monitoring, gram stain, sterility, en-dotoxin, and mycoplasma.

Execute Global Medical Affairs vitreoretinal strategic tactics (lab studies part of the Phase IIIB/IV study plan).ﾠ

Perform Bioanalytical testing in support of clinical and commercial release strategies.ﾠ

Qualified individuals will be responsible for performing assay qualification and validation as well as analytical testing on in-process samples, drug substance and drug product for release and in support of stability studies.ﾠ

Sample testing, experimental documentation and data analysis in a regulated setting;Provide analytical support for process development of vaccine products using analytical techniques, such as UV-Vis spectroscopy, BCA, SDS-PAGE, Western Blot, RP-HPLC, sandwich ELISA immunoassay.

Main function will be to perform the day to day activities in the Solutions Preparation Area: preparation of buffers, preparation of cell culture media/feeds, calibration of pH and conductivity meters/probes, transport of glassware, scheduling equipment maintenance, etc., to support all of process development.

The researcher will be responsible generating yeast strains for biofuels applications. The candidate will support the development of techniques to improve strain building and screening processes including automation of high throughput processes.ﾠ

seeking a highly motivated and creative research associate to characterize and test drug conjugatesﾠin-vitroﾠas well as analyze tissue and blood samples from outsourcedﾠin-vivoﾠstudies.

The QC Analyst I/II - Microbiology performs quality activities in support of product production and releases. The QC Analyst I/II communicates with internal departments at Organogenesis and with outside contacts including contractors and suppliers. The QC Analyst I/II performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing and reporting results. This individual works in Microbiology environment.

QA support to all other departments within PAION;Assist in the maintenance and management of PAION's QMS;Batch review for API, bulk and packed/labelled material and co-ordination and control of certification/release process together with QPs.QA support to all other departments within PAION;Assist in the maintenance and management of PAION's QMS;Batch review for API, bulk and packed/labelled material and co-ordination and control of certification/release process together with QPs.

ﾠThe R&D Scientist is responsible for the hands-on development of immunoassays, such as ELISAs and cell-based assays, for commercial production. This individual plans and executes assay development strategy and aids in the transfer of the assays to the Manufacturing department for final commercialization. The R&D Scientist is also responsible for development of custom assays and reagents for clients.

As a Quality Assurance Engineering Specialist at Penumbra, you will support quality engineering activities designed to ensure that all processes, products and systems meet the highest standards of quality and compliance with domestic and international regulations.

The individual will be responsible for development of assay, impurities, dissolution, water content, and physical characterization methods for liquid and solid oral drug products. There is an expectation of both direct hands-on laboratory work as well as, depending on level of experience, mentoring/training of colleagues.

As a member of the Analytical team, the research technician will conduct analytical experiments, analytical methods and document results for product development.ﾠ