- Legend Biotech USA, Inc. (Raritan, NJ)
- …issues or issues resulting in the delay of investigation closure and product release. Support regulatory inspections and audits by ensuring inspection readiness ... occur in the production of a personalized cell therapy product in a sterile GMP environment. The ideal candidate...or cell therapy.Knowledge of cGMP and GDP regulations and FDA/ EU guidance related to manufacture of cell based… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cabinets utilizing aseptic technique is strongly preferred.Knowledge of cGMP regulations and FDA/ EU guidance related to manufacturing of cell- based products is ... chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell- based immunotherapy. From our three R&D sites around the world, we apply… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …knowledge and understanding of GMP data integrity standardsKnowledge of cGMP regulations and FDA/ EU guidance related to manufacturing of cell based products as ... chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell- based immunotherapy. From our three R&D sites around the world, we apply… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product /process is ... in ISO 5 clean room and biosafety cabinets.Knowledge of cGMP regulations and FDA/ EU guidance related to manufacturing of cell- based products as well as… more
- Merck & Co. (Ames, IA)
- …of manufacturing, technology, and/or quality experience within an FDA, USDA, and/or EU API, Drug Product , Medical Device, or equivalent environment.At least ... will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below aspects of the Supplier Quality Management (SQM)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …testing facility, quality assurance, or manufacturing complianceKnowledge of cGMP regulations and FDA/ EU guidance related to manufacturing of cell based products ... chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell- based immunotherapy. From our three R&D sites around the world, we apply… more
- Cipla (Fall River, MA)
- …Fall River, MA Work Hours: Third Shift: 11:00 PM - 07:30 AM (May vary based on business needs) Reports To : Packaging Supervisor Salary Range : $19.00/Hr. Purpose : ... Operator. As a secondary requirement, this position will be expected to provide support to other operational functions to include but not limited to Warehouse… more
- Cipla (Hauppauge, NY)
- …benefits. Overview The QA Inspector is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing and packaging in ... & batch packaging record instructions. Collection of in-process blend, finished product , validation samples for analysis, sample collection as per protocols.… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. What ... This role will be part of our bioproduction downstream purification process support team, dedicated to one of our manufacturing suites. Responsible for supporting… more
- Cipla (Fall River, MA)
- …MA Work Hours: First Shift: 7:00 AM - 03:30 PM (May vary based on business needs) Reports To: Packaging Supervisor Salary Range: $19.00/Hr.Purpose: The purpose ... Operator. As a secondary requirement, this position will be expected to provide support to other operational functions to include but not limited to Warehouse… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …applications, quality systems, or learning management systems.Knowledge of cGMP regulations and FDA/ EU guidance related to manufacturing of cell based products ... chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell- based immunotherapy. From our three R&D sites around the world, we apply… more
- Cipla (Fall River, MA)
- …: Fall River, MA Work Hours: Second Shift: 03:00 PM - 11:30PM (May vary based on business needs) Reports To : Facilities Maintenance Engineer Salary Range: $21.32 - ... Technician. As a secondary requirement, this position will be expected to provide support to other operational functions to include but not limited to Packaging… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and tracking of quality metrics while ensuring high quality and complaint product supply.Key Responsibilities Support compliance activities for site Quality ... over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile...clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA/ EU guidance related to manufacturing of cell based… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell- based immunotherapy. From our three R&D sites around the world, we apply ... myeloma.Legend Biotech is seeking Supervisor, QC Micro as part of the Quality team based in Raritan, NJ. Role OverviewThe Supervisor, QC Micro is an exempt level… more
- Formation Bio (New York, NY)
- …extend product registrations. Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and ... marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life cycle support and the… more
- Cipla (Hauppauge, NY)
- …Location : Unit 1, Hauppauge, NY Work Hours: General: 8:30AM - 5:00PM (may vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - ... The incumbent to this role performs and oversees cGMP compliance- based services (commissioning, qualification, validation, consulting, etc.) on equipment and… more
- Cipla (Fall River, MA)
- …Location : Fall River, MA Work Hours: First Shift: 8:30AM - 5:00PM (May very based on business needs) Reports To : Warehouse Coordinator Salary Range $25 - $28/hr ... Operator. As a secondary requirement, this position will be expected to provide support to other operational functions to include but not limited to Packaging… more
- Insmed Incorporated (NJ)
- …strategies to ensure successful development of CMC submission packages to support product life cycle management.Work effectively with regulatory colleagues ... documents and disposition of proposed changes and scheduling submissions as necessary based on the changes.Keep abreast of all pertinent regulations and guidance… more
- Teradyne (San Jose, CA)
- …candidate must be located in this region. + Serve as a technical expert to support customer teams with product differentiation, demos, and proofs of concept. + ... industrial applications. Our Purpose LitePoint is seeking a Field Product Specialist (FPS) to lead technical customer engagements for...partners. This position will cover multiple key accounts primarily based on the West Coast of the US, including… more
- embecta (Parsippany, NJ)
- …strategies and execution on embecta growth initiative projects. The role will support full product life cycle management activities which include identification ... growth and life balance components - is designed to support the varying needs of our diverse and global... EU MDR regulatory submissions to FDA and EU notified bodies. + International product registration… more
