Links to 1024 Entry-Level Biotechnology & Life Science Jobs

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

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

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

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

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.

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 a

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 Sr. Drug Product Manufacturing Assistant responsible for implementation of semi-routine production and manufacturing procedures to optimize processes and regulatory requirements.

The QA Assistant is performing a wide variety of routine and semi-routine activities pertaining to assuring compliance with Quality Assurance (QA) requirements and applicable regulatory requirements, including assisting with audits and documentation review.

The position works under the guidance of experienced downstream team members in support of the successful technical transfer and integration of processes into the Drug Substance Manufacturing Downstream department. The position will become proficient with chromatography and TFF (UF/DF) systems employed during manufacturing campaigns. Compliance with established Good Manufacturing (GMP) procedures, safety, and regulatory regulations is required. The position aligns daily actions with company goals and Althea’s cultural values.

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.

In this role, you will support Aldevron's quality assurance programs, processes and facilities by ensuring compliance with regulatory, internal and client requirements in the manufacture of products. You will act as quality representative on the floor during manufacturing operations

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

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.

You will be responsible for providing technical support for process manufacturing, including investigation and correction of process-related problems and deviations from standards.

Designs and develops implants and instruments utilizing SolidWorks; Assists in the development of new products and manufacturing processes and/or serves as a member of a development team.

As an Instruments and Accessories Test Engineer, you will contribute to the development of various instruments and accessories used with a robotic platform for surgical applications, focusing on design support, testing, automation, and analyzing instruments and accessories. This position reports to the Test Engineering Department Lead.

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

The Research Associate provides laboratory support for Process Development and performs a range of activities (while the Sr. position performs at a senior level). The employee may be assigned various tasks within the department to complete.

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.

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

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

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

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

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

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

Bio-Technical Resources is seeking an Assistant Research Scientist to work with supervision as an analytical research assistant supporting teams developing fermentation and biotransformation processes for the production of antibiotics, enzymes, proteins,

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

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

As a member of Biogen’s Drug Product development team, the candidate will be responsible for providing formulation and process development support for injectable protein drug product development programs. Planning, executing, and communicating results fro

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 purification 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 Production Associate will participate in producing recombinant proteins of cytokines, growth factors, hormones, and enzymes from bacterial to mammalian expression systems and will be involved in general lab duties such as maintaining lab supplies and inventory management.

The Manufacturing Associate will be an important member of our Finished Goods Inventory/Bulk Inventory team that supplies purified bulk antibodies for finished goods and custom bulk orders. This position will be responsible for performing all essential functions related to FGI and bulk antibody processing, including verifying specifications and sales order information, reviewing available inventory, adjusting concentration, performing buffer exchange if necessary and endotoxin assays. These materials will support customers in the areas of Immunology, Neuroscience, Cancer, Stem cells, and Cell Biology. This position will also interact with external groups including Planning, Bottling, Customer Service, Marketing and Internal Sales. This is a great opportunity to enhance your knowledge in the biotechnology industry.

The Manufacturing Associate will be working closely with the manufacturing lead and others on the team to ensure the timely production of high quality multiplex bead-based immunoassay products. The primary responsibilities for this position are performing

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

This position will be an individual contributor role within the Purification Team and will be responsible for performing all essential functions related to antibody purification. Essential tasks for this position include: following Standard Operating Pro

BioLegend is seeking a highly motivated Quality Control Associate to join our Research and Product Development Team. This position will work under minimal guidance to perform quality control testing in a fast-paced, goal-orientated environment. The responsibilities include, but are not limited to, performing assays using a variety of approaches such as primary cell preparation, cell separation, immunofluorescent staining, and flow cytometry (FACS) data analysis, performing experiments (e.g. cell preparation, cell separation and flow cytometry testing), analysis and reporting of data, maintaining accurate documentation, using internal company databases for product filing and retrieval, and following company SOPs and ISO requirements.

This position is an individual contributor role within the Product Development team and will responsible for performing all essential functions related to antibody purification such as following procedures, optimizing processes, troubleshooting problematic results, performing buffer preparation, pre- and post-purification sample preparation, and database entry. This position is an individual contributor role within the Product Development team and will responsible for performing all essential functions related to antibody purification such as following procedures, optimizing processes, troubleshooting problematic results, performing buffer preparation, pre- and post-purification sample preparation, and database entry. This position is an individual contributor role within the Product Development team and will responsible for performing all essential functions related to antibody purification such as following procedures, optimizing processes, troubleshooting problematic results, performing buffer preparation, pre- and post-purification sample preparation, and database entry.

The Regulatory Affairs Associate will work with BioLegend's existing Quality Team to assist with meeting FDA requirements for class I medical devices, (IVD and ASR), and International In Vitro Diagnostic Medical Devices Directives. The RA Associate is also responsible for ensuring that products and their labeling meet all regulatory requirements (national and international).

The Production Associate will an integral part of BioLegend's Recombinant Protein routing and will be responsible for performing routine cell culture, protein production, and raw material preparation in manufacturing scale and inventory maintenance. This position will also function as a member of the Molecular Cellular Immunology team to assist with intergroup tasks.

The Regulatory Affairs Associate will work with BioLegend's existing Quality Team to assist with meeting FDA requirements for class I medical devices, (IVD and ASR), and International In Vitro Diagnostic Medical Devices Directives. The RA Associate is also responsible for ensuring that products and their labeling meet all regulatory requirements (national and international).

The Manufacturing Associate will be an important member of our Finished Goods Inventory/Bulk Inventory team that supplies purified bulk antibodies for finished goods and custom bulk orders. This position will be responsible for performing all essential functions related to FGI and bulk antibody processing, including verifying specifications and sales order information, reviewing available inventory, adjusting concentration, performing buffer exchange if necessary and endotoxin assays. These materials will support customers in the areas of Immunology, Neuroscience, Cancer, Stem cells, and Cell Biology. This position will also interact with external groups including Planning, Bottling, Customer Service, Marketing and Internal Sales. This is a great opportunity to enhance your knowledge in the biotechnology industry.

The Tissue Culture Associate position will be responsible for handling hybridoma lines in preparation for potential manufacturing activities. Functions will include culturing, subcloning, small-scale and large-scale production runs, banking, performing characterization assays, adaptations of cells to different media and/or conditions, and decontamination of cell lines as needed. All performed work will be documented in lab notebooks, controlled forms, and databases. This position is expected to work independently and in a team environment under established safety guidelines. Communication with various department representatives is expected with emails and meetings.

The Research Assistant/Associate is involved with the design of protein purification processes suitable for manufacturing therapeutic proteins or gene therapy vectors, and with the transfer of those processes to manufacturing facilities. The Assistant/Ass

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).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

This position will work in the GMP compliant QC Laboratories to qualify, and conduct cell-based, nucleic acid-based, protein-based, and chemistry-based assays that support quality control of biopharmaceutical products being developed and manufactured. Will perform routine assays and testing including PCR, real time PCR, agarose gel electrophoresis, SDS-PAGE, immuno blotting, ELISAs, immunocytochemistry, and infectivity and reporter gene based cell assays using insect or mammalian cell lines. Functions also involve maintenance of cell lines used in the QC laboratories, maintenance (routine and preventive operation) of equipment, and preparation and purification of commonly used biological reagent and chemical supplies. The incumbent will be expected to technically interpret, write controlled documents and reports, and review data produced by self and participate in laboratory investigations. Will interact with other departments to ensure that sample flow, supply chain, and equipment disposition are correctly maintained.

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

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

This position will work in the GMP compliant QC Laboratories to qualify, and conduct cell-based, nucleic acid-based, protein-based, and chemistry-based assays that support quality control of biopharmaceutical products being developed and manufactured. Will perform routine assays and testing including PCR, real time PCR, agarose gel electrophoresis, SDS-PAGE, immuno blotting, ELISAs, immunocytochemistry, and infectivity and reporter gene based cell assays using insect or mammalian cell lines. Functions also involve maintenance of cell lines used in the QC laboratories, maintenance (routine and preventive operation) of equipment, and preparation and purification of commonly used biological reagent and chemical supplies. The incumbent will be expected to technically interpret, write controlled documents and reports, and review data produced by self and participate in laboratory investigations. Will interact with other departments to ensure that sample flow, supply chain, and equipment disposition are correctly maintained.

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

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

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

The Regulatory Affairs Specialist is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team.

Under the general supervision of the Microdissection / Histology Supervisor and Medical Director, the Microdissection Technician is responsible for the day-to-day performance of solid tumor H&E screening and microdissection procedures.

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.

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

Performs Biological testing to support Manufacturing of products. Prepares and monitors tests and paperwork to support documentation, GMP and FDA requirements. Documents activities and demonstration of proficiency in SOPs. Demonstrates proficiency of techniques and competency of various production operations.

Process customer samples in the microbiology laboratory utilizing the various technology platforms including but not limited to bacterial 16S rDNA and fungal ITS2 sequencing, MALDI-TOF mass spectrometry and ribotyping. Ensure adherence to regulatory requirements and GMP compliance.

Performs technical laboratory activities in support of client studies or procedures. Performs analysis of data for quality and completeness and determines if results are as expected. Records data in compliance with company and regulatory policies and standards to meet quality and accuracy requirements. Perform within the MDX laboratory to process and interpret internal and external samples by performing PCR testing (to include Taqman based PCR on 96 well and 384 well platforms) using aseptic technique. Reconcile customer paperwork with submission documentation to ensure accuracy. Make detailed observations and maintain documentation of all laboratory work. Analyze data and report testing results with respect to department turnaround time.

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

The Report Coordinator Associate is responsible for: coordinating the reporting processes to produce quality, on-time reports; providing support for assigned Study Director(s); and prioritizing his/her workload. Good communication skills and the ability to adhere to deadlines are necessary for success.

We are seeking Research Associate candidates that are early in their careers and are highly motivated, enthusiastic and possess a passion for learning. This individual will work closely with more senior colleagues to contribute to the establishment and delivery of discovery bioanalytical (small Molecule) services from our new location. This position is ideally suited to recent graduates who enjoy a fast-paced and collegial environment. The individual in this position will be responsible for working hands-on and under the direction of more senior staff in a dynamic environment where teamwork, data quality, innovation and speed are valued.

Under general supervision, responsible for providing, coordinating, documenting and scheduling orientation and routine to moderately complex training activities. Also responsible for developing, revising, and implementing the use of training documents including SOPs and processes to support the overall training program.

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

This position will be 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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Perform advanced necropsy laboratory procedures including but not limited to: dissection, tissue collection/preservation, fresh tissue trimming, sample collection, data entry, tissue weights, coordinate unscheduled activities, prosection, perfusions, assay specific requirements, CSF collection, and electronic QC, in compliance with appropriate SOP, Protocol, and Regulatory Agency guidelines. Will perform administrative roles within department. Knowledgeable of inter-site processes and procedures and can identify gaps for process excellence. Serve as a resource for others in an area of specific focus. Must know correct anatomic terms.

Manipulation and handling of mice in a lab setting；

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

Responsible for performing research and laboratory tasks for projects and products in collaboration with internal, external, and global R and D peers.

Performs deviation investigations for manufacturing using site procedures to ensure root cause is identified and appropriate corrective actions are put in place within 30 business days.

The successful candidate will actively participate in experimental design, performing experiments, and troubleshooting, as well as performing data analysis and interpretation. The ideal candidate will be independent, self-motivated, collaborative and able to multitask effectively while frequently under pressure to meet tight deadlines.

The successful candidate will actively participate in experimental design, performing experiments, and troubleshooting, as well as performing data analysis and interpretation. The ideal candidate will be independent, self-motivated, collaborative and able to multitask effectively while frequently under pressure to meet tight deadlines.ﾠ

The Operations Engineer is responsible for equipment, facility, and utility (EFU) lifecycle management. This includes managing the specification, procurement, installation, and commissioning of new EFU assets; contributing to the development of calibration, maintenance, operation, and cleaning procedures; providing technical support to end user, quality, and maintenance personnel; and managing the decommissioning of EFU assets to be retired. The Operations Engineer is quality-centered and follows company standard operating procedures (SOPs) geared toward FDA and other applicable regulations and in-line with current good manufacturing practices (cGMPs).

The QC Associate will participate in the entire range of quality control analytical activities: assay performance, qualification/validation of assays and laboratory equipment, and transfer of standard protein characterization methods. Duties will be carried out in accordance with quality standards and procedures set by the company and applicable government agencies.

The Senior Manufacturing Engineer supports the development, implementation and maintenance of manufacturing methods, techniques, processes, and tooling on fabricated parts, components, subassemblies, and final products. Interfacing as appropriate with Development, Quality, Manufacturing, Purchasing and suppliers, the incumbent assists with coordinating the release of new and enhancements to existing products; participates in design reviews, inspections and MRB processes; aids the development product structures; provides technical support for internal and external suppliers; participates in the resolution of technical issues; and ensures manufacturing documents are created, updated and in compliance with company standards, ISO and GMP as required.

Maintain programs and policies in place to ensure legal and regulatory compliance with National and International chemical regulations. Provide support for corporate compliance and key objectives through continuous improvement and other corporate policies.

ﾠThe successful candidate will work as part of a team and apply their skills to identify kinase inhibitors that selectively block cancer or immune cell targets of interest.

Under guidance and detailed instructions, plans, designs, tests, and develops mechanical systems, parts, equipments and packaging. Applies basic knowledge of engineering principles to design simple components and assemblies. Conducts engineering analysis and testing 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. 90% of time is spent in a resource capacity. 10% of responsibilities are in leadership activities.

Conduct the controlled substance inventory audits for manufacturing, analytical, import & export registrations.

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.

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

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

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

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

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

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

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

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

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

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

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

Perform lab-scale downstream processing of vaccine products and process intermediates;Perform assays on vaccine products, process intermediates, and related experimental samples using biochemical/analytical tests.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Responsible for working under the guidance of the Lab Manager, Investigators; Management, Study Coordinator and Supervisor, to perform study procedures required in clinical studies conducted on behalf of sponsors at the Frontage Clinical Services.

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

Scientist / Bioanalytical Services Essential Functions Run sensitive, reliable and efficient LC-MS/MS bioanalytical assays for TK/PK assessment.

Perform basic laboratory work in BSL 2 Laboratory; Perform cell culture and cell passage with minimal assistance;Perform cell culture and cell passage with minimal assistance.

Performs QC microbiological aspects of cGMP compliance and testing.

Function as primary shift technician for environmental monitoring.

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

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.

As a Project Engineer, you will work closely with Senior Engineers and lead New Product Development (NPD) of engineering projects for the Power Generation and Sensor team on projects involving high speed permanent magnet alternators and other similar machines, power electronics and regulators, temperature sensors, and probes.

The integration engineer performs integration design for solution deployment on a given customer.

Perform all functions of the job with the highest level of compliance and integrity.Integrate the BHGE Safety Culture of HSE ownership throughout all areas of the facility.

Prototype, design, develop and document next generation products, including both bioprocess equipment and consumable single-use products such as in GE’s Xcellerex, WAVE, and Ready-To-Process product lines

A GeneDx DNA Sequencing Lab Technician in the Sanger Sequencing Laboratory 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.

A GeneDx MicroArray 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.

The GeneDx Product Development Associate plans and coordinates product test development, launch, and marketing functions.

A GeneDx DNA Sequencing 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.

A GeneDx MicroArray 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.

A GeneDx Cytogenetics Lab Technician performs a higher than entry level role in clinical cytogenetic analysis for the purpose of diagnosing genetic disease using manual and automated methods in a team environment, and following established policies and procedures in a professional manner.

The successful candidate will be part of the team designing and implementing bioanalytical and biophysical assays to characterize Generation Bioﾒs close-ended DNA genetic medicine products. This role will be reporting to the group leader for bioanalytical/biophysical assays and will further our understanding of this novel scientific modality.ﾠ

Prepare amplified template libraries for high-throughput sequencing; Carry out DNA sequencing on next-generation DNA analyzers.

The Process Engineer will be responsible to drive stable, reliable production processes for new manufacturing processes recently transferred to production. Under minimal supervision, the Process Engineer will develop and characterize manufacturing processes, including surface treatment (i.e. plasma, CO2 cleaning) and precision dispensing of fluids and adhesives. This position will be instrumental in creating and maintaining process input and output specifications, perform capacity analyses, troubleshoot, test, and support for existing products and new product lines.

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

The Clinical Trial Assistant I ("CTA") at Genomic Health, Inc. ("GHI") is responsible for assisting Clinical Operations team with studies to support the development and commercialization of novel genome-based assays, which lead to improved treatment decisions for patients with cancer.

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.

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

Gilead Sciences is seeking a Sr Research Associate I with experience in protein purification process development to support operations at our biologics development and manufacturing site in Oceanside California.

Enzyme purification and characterization; Data analysis; Automate protocols.

Are you an analytical graduate who wants a career with real purpose? On our tailored development program within R&D (Consumer Healthcare), you’ll make consumers’ lives easier through our targeted scientific efforts all over the globe. Working through four rotations (each nine months long), you’ll gain the knowledge and skills to move quickly into more senior positions within the R&D function.

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

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

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

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

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

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

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 within the Microbiology Laboratory and/or conduct critical microbiological analysis on test articles from all stages of the manufacturing process from incoming raw materials to finished goods. The duties also include equipment maintenance and LIMS management.

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

The Quality Assurance Associate Specialist promotes high quality standards and a continuous improvement culture within the Quality area of the New Jersey site in order to ensure that these are aligned with applicable quality regulations and the company's high quality standards. This role provides support in achieving the department objectives and supports the cGMP programs (i.e. validation, qualification, stability, and environmental control).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Medical Technologist is responsible for performing laboratory testing (including potency, specificity, reactivity and hemagglutination assays) and chemical evaluations (including protein, absorbance, chloride, osmolality, and pH) of Immucor products according to approved Standard Operating Procedures (SOP’s) within defined timeframes.

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

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

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

Drug Safety Coordinator

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

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

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

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

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

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

Support strategic product launches and ongoing maintenance of existing products by coordinating the collection, creation, approval, and implementation of core product labeling, surgical techniques and instructions for use (IFU)

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.

We are seeking a motivated and talented Research Associate to develop and perform in vivo and in vitro bioassays on mice and rats. The Research Associate should have excellent skills in basic rodent procedures. Rodent surgery skills are a plus. Experience with biochemical and tissue culture techniques is a plus. Excellent communication and computer skills and motivation to learn new assays are essential. Ability to work in a highly interactive and multidisciplinary team environment.

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

Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation

Perform cell culture experiments for development of cell biology and embryology research, product development, technical product support, and/or process improvements.

Process development, optimization and scale up of biotechnological processes (USP and DSP) to produce proteins for our reagents

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.

Just is seeking a motivated and creative scientist or engineer who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for a someone to join a fast-paced, collaborative, and multidisciplinary team to develop purification processes for low-cost biotherapeutic manufacturing. The successful candidate will have some experience in chromatography and/or filtration operations. Experience with high throughput robotics, statistical analysis and/or process modeling is a plus. The ideal candidate has strong written and verbal communications skills and works well independently and in teams. Just is seeking a motivated and creative scientist or engineer who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for a someone to join a fast-paced, collaborative, and multidisciplinary team to develop purification processes for low-cost biotherapeutic manufacturing. The successful candidate will have some experience in chromatography and/or filtration operations. Experience with high throughput robotics, statistical analysis and/or process modeling is a plus. The ideal candidate has strong written and verbal communications skills and works well independently and in teams.

Develop and test cell culture media formulations using analytical and cell culture models; Develop and apply new methods to advance cell culture media technology.

A Scientist will be a key technical resource responsible for independently developing methods, generating reliable and interpreting data, using analytical instrument that include HPLC, UPLC, GC, UV/Vis, Mass spectrometer, dissolution apparatus and particle analyzer. You will be expected to develop a close working relationship with Technical personnel at all levels within the organization to provide technical support needed in meeting R&D milestones and goals.

Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP’s and batch records. Responsible for various duties that are required to produce product including but not limited to cell expansion; cell feeding, harvesting, counting and freezing; product seeding; growth system maintenance; labeling, packaging and freezing of product; and culture media preparation. Follow specific techniques and operations while demonstrating an understanding of cGMPs and how they apply to specific responsibilities

Perform data review for contract services projects, including analytical and formulations programs for monoclonal antibodies, recombinant proteins, peptides, and small molecules in a variety of dosage form such as liquids and lyophilized powders and suspensions for injection, topical gels, and other novel delivery systems.

Coordinate and perform cGMP manufacturing operations for biopharmaceutical products. Ensure the effective use of material, equipment and personnel while making products with the highest quality.

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

The scope of this role will include routine sample prep and processing through our workflow in accordance with our established Technical Operating Procedures.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The candidate will provide support to the Process Development group.

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

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

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

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

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

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

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

Provide planning and coordination support for the Hearing Conservation Research Program

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

Responsible for supporting the Validation Engineers.

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

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

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

We are seeking individuals who are passionate about research, bring out of the box thinking and take bold steps to develop innovative technologies with applications in the ubiquitin research field. Successful candidates will have basic knowledge of biochemistry and molecular biology techniques, in particular experience with, protein expression and purification and cloning. Knowledge of the ubiquitin proteasome pathway is desired.

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

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

Assist the Liquidia manufacturing team with various tasks and projects.

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

This position will have responsibility for supporting all activities in the Quality Control Laboratory. This includes the testing of R&D samples, in-process samples, finished product samples, stability samples, and raw materials. This may also include assisting in the performance of instrument validations, cleaning validations, and method qualifications as deemed appropriate by management.

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

QA Associate I - Ops

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.

Assist with Administration of clinical research projects: site and investigator recruitment, collecting investigator documentation, site management, site monitoring, preparing and maintaining proper status reports of activities at investigative sites through the duration of a clinical trial and completing other technical tasks to completion.

Utilizing your knowledge of fundamental theories, principles, and concepts as the Quality Assurance (QA) Specialist I, you will be contributing to all relevant documentation areas to support the QA team meet its functional deliverables as outlined in the cGMP and organizational standard operating procedures (SOP).

The successful applicant will work as part of a collaborative team to engineer microbial strains for improved production of bio-based chemicals. The position will involve the construction of combinatorial strain libraries, measurement and analysis of strain performance, and the development and application of assays to improve enzyme properties or interrogate cellular conditions. Research objectives are milestone driven.

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.

The successful candidate will support laboratory staff by performing routine cell culture, running cell assays, preparing media and buffers, and maintaining laboratory supplies and glassware. Additionally the successful candidate will play a role in the development and production of new products

Regulatory Affairs is responsible for obtaining and documenting our mission-critical, domestic regulatory clearances for Masimo’s amazing innovative products. The individual will be the sole RA representative on various project teams for new products. For each project, the individual will provide regulatory input on, for example, design, labelling, and clinical testing issues. Thus, the individual must work closely with Engineering and Marketing team members to understand the technology, marketing and clinical application of each new product.

ﾠThe successful applicant will become a core member of a highly interactive team of senior and junior scientists who bring with them an expertise in lipid biology, drug-discovery, pharmacology, assay development, liver lipid biology, and mouse models of liver disease.

Medical Diagnostic Laboratories, LLC (MDL) is a CLIA certified clinical laboratory with multiple state licensing, specializing in state of the art, automated DNA based molecular analysis of a variety of chronic and infectious illnesses. The Oncoveda Cancer Research Center at MDL is looking for a motivated individual to work as a Research Associate. The successful candidate will contribute to the work of a multi-disciplinary community of scientists, supporting the development of novel therapeutics.

Perform manual Enzyme Linked Immunosorbent Assay (ELISA) and automated ELISA tests using DSX Automated Processor on patient serum samples.

Regularly works, under moderate supervision, on routine manufacturing and other assignments that are moderately complex in nature, where judgment is required to make recommendations and resolve problems. Adheres to instructions as needed on routine work and more detailed instructions on new assignments. Adheres to Good Manufacturing Practices and standard operating procedures. 

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

Specifically, the candidate will be part of a team that is developing in vivo expressed biologics that will prevent or treat of respiratory diseases such as COPD, asthma and respiratory tract infections. 

As a Process Controls engineer, you’ll play a pivotal part in detailed design, writing PLC code, HMI graphic design, installation and maintenance of automated systems in support of clinical manufacturing operations. 

Responsible for assisting in the development of high-quality clinical regulatory and other supporting documents for pipeline and/or marketed products as well as assisting in the development of high-quality clinical abstracts, posters, and manuscripts. Works under direct supervision to manage and prioritize workload to ensure deliverables are completed per time and quality goals.

We seek a highly motivated candidate to be part of a process development team for the manufacture of recombinant monoclonal antibodies, therapeutic proteins and other biologics using mammalian expression systems. Responsibilities will include, but are not limited to, routine sub-culture of cells using aseptic technique, development of seed train and bioreactor process, media and feed development, process robustness characterization, maintenance of lab equipment and areas, providing technical support for cGMP production, and authoring reports and regulatory documents. The candidate should maintain current knowledge of scientific literature and keep detailed and accurate records of experimental activities. The candidate will be expected to design and analyze experiments as well as to present data at internal meetings and, as appropriate, at external conferences. The candidate is expected to perform independently with minimal supervision after an initial training period.

Responsible for conducting raw materials, in process, finished product and stability testing according to standard operating procedures.

Conducts the validation plans and processes for facilities, laboratory equipment, utility systems and process equipment.

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.  Industry internship experience is a plus. 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.

The main duties for the ideal candidate are to help build gene- and stem cell-based approaches to support MedImmuneﾒs pipeline projects. This candidate will be responsible for optimizing and testing viral vectors for transduction efficiency, sustainability, safety and manufacturability. You will also be responsible for maintenance and differentiation of pluripotent stem cells. You will plan and execute experiments on the bench. In addition, you will be working in a multidisciplinary matrix environment to design strategies towards clinically relevant strategies.

Develop and characterize downstream processes for the manufacture of biopharmaceuticals (monoclonal antibodies and other proteins) in late stage clinical development through commercial launch.

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

Conductﾠqualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol

Under general supervision, candidate works independently on moderately complex verification testing assignments. Candidate will develop and validate test methods, both manual and automated. Candidate will work cross-functionally to ensure proper test coverage of design requirements.

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. 

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,

The Associate Manufacturing Engineer is responsible for providing daily support of multiple product families with specific regard to product quality, product cost, process improvements, safety, and customer feedback. Areas of responsibility include chemical, polymer extrusion, textile, and bio-medical processes. Duties include managing and/or participating in cross functional teams to accomplish project specific goals. This person will be mentored to become the resident expert on production equipment and processes, plus play a supporting role for new products transitioning from R&D into manufacturing production. Key responsibility will be to insure efficient product processing while maintaining established quality/cost/safety standards.

The Manufacturing Engineer is responsible for providing daily support of finished good level suture manufacturing with specific regard to safety, product quality, service, process improvement, and customer feedback. Duties include participating in cross functional teams to accomplish project specific goals, root cause analysis, and developing and implementing robust corrective and preventive action plans. This person will be mentored to become the resident expert on assembly, packaging, and automated production equipment and processes, to develop strong project management skills, and to lead teams of his/or her peers.

The Product Engineer will prioritize daily production activities, improvements, scheduling and production tracking. The Position is in a fast-paced, and collaborative environment that is supportive of program initiatives and compliant with the company’s best practices, Tenets and Philosophy.

Frequent use and application of laser welding technical standards, principles, theories, concepts, and techniques. Capable of learning and performing all required competencies in the laser welding functional area. Basic understanding of mechanical testing and failure modes of laser welds. Can evaluate and identify critical laser weld inputs and outputs, & design and analyze an appropriate DOE (full factorial, minitab). Basic understanding of heat balance, flow, tooling, and equipment development.

Supports the manufacture of Medtronic Neurovascular products to ensure operations core metrics of safety, quality, product availability, cost, and organizational excellence. Provides manufacturing floor support, contributes technical expertise, and leads implementation of manufacturing improvements to assigned product lines.

This position is with the Released Integrated Circuits (IC) Product Engineering group. This group is responsible for ICs in multiple technologies as they transition from Product Development through obsolescence. There is a tremendous focus on quality and reliability since many of these ICs will be used in Implantable Medical Devices. The group conducts product monitoring ensuring stable supply to our customers and leads cost improvement projects through yield improvements, and cost reduction activities. Additionally, the group also monitors and supports root cause analysis of field returns and product non-conformances to drive product improvements.

The Associate Quality System Specialist is responsible for participating in the development, documentation, maintenance, and improvement of the business’s Quality Management System, including quality policies, processes, procedures and controls that monitor system performance and ensures conformance to established standards necessary to maintain quality of products and sustainable customer satisfaction. The incumbent also will facilitate and participate in the Corrective and Preventive Action (CAPA) and Product Experience (PE) Systems as well as coordinate all audits activities as necessary at MNS in accordance with FDA QSR, ISO 13485, MDD and Canadian Medical Device Regulations.

A new product development team for the Surgical Innovation business in Medtronic’s Minimally Invasive Therapies Group (MITG) Business Unit is seeking a Test Engineer. The Test Engineer shall support test activities to best meet the project’s requirements. This position will be a part of a R&D Systems Engineering team and will interface with cross-functional team members.

Partners with Design Engineering to identify Design for Manufacturability and Assembly targets; Creation and execution of process characterization and validation protocols.

We are looking for a Scientist/Engineer with a strong foundation in chemistry, materials science and/or polymer science to join our team. In collaboration with internal and external partners/vendors, the candidate will plan, initiate and execute studies aimed at improving the biocompatibility of existing continuous glucose sensors and developing various chemistries for next generation sensor technology platforms. Strong organizational and communication skills are required to collaborate with other staff and complete required activities in a timely manner. The individual must be able to handle multiple competing priorities in a fast-paced environment.

Under general supervision, candidate works independently on moderately complex verification testing assignments. Candidate will develop and validate test methods, both manual and automated. Candidate will work cross-functionally to ensure proper test coverage of design requirements.

Design and development of transcatheter heart valves, manufacturing processes, and test methods used in the manufacturing and design characterization of medical device implants in a regulated environment. Activities will include Nitinol heart valve frame design, methods/process development, tooling design/fabrication, equipment design/fabrication, qualification, validation, project management, failure analysis, regulatory submission, and documentation. Supports development projects in multi-functional project teams.

Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.