- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in ... Raritan, NJ. Role OverviewThe QA Manufacturing Excellence Manager role is an exempt...years must include MSAT experience.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone ... is responsible for investigating and writing of deviations to the manufacturing process and other operational problems as assigned. This position is… more
- Novo Nordisk Inc. (Durham, NC)
- …of demonstrated performance in the role/relevant area in lieu of work experience FDA regulated industry & solid dose manufacturing experience preferred Ability ... of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary: Exela Pharma Sciences is seeking an experienced and dynamic Senior Manager , IS Quality to build and lead our IS Quality function. The ideal ... solutions.Required Skills: Proven success leading cross-functional teams in an FDA regulated environment, excellent communication and interpersonal abilities, and… more
- Aequor (Thousand Oaks, CA)
- …years of relevant work experience with 1&plus years' experience in operations/ manufacturing environment Direct experience with regulated environments ( FDA , OSHA, ... Onsite at ATO Looking for a Senior level PM who will support manufacturing plant and engineering group, This person needs to have process/utility Engineering… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …maintain current knowledge of cGMP regulatory issues, Good Automated Manufacturing Practices (GAMP5) and Good Practices Guides, Risk-Based Approach/Computer Software ... related to pharmaceutical operations. required- 1 or More Years Direct dealings with FDA , EMA, PMRA, other regulatory agencies. preferred- 1 or More Years Strong… more
- Insmed Incorporated (San Diego, CA)
- …join the Quality Control leadership team. As the QC Stability and Sample Management Manager , you will be responsible for the daily oversight for the QC stability and ... and sample management (eg, JMP, Labware LIMS)Collaborate with Quality Assurance, Manufacturing and CMOs, Material Management, and other functions to ensure internal… more
- Merck & Co. (Lenexa, KS)
- …response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies.The successful candidate for this position will ... daily in-person attendance is required for, field-based positions; facility-based, manufacturing -based, or research-based positions where the work to be performed… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents where necessary with supervision.Health Authority Interactions: Leads US FDA /EU EMA interactions with support from higher-level manager .Regulatory ... biological developmental projects with supervision, including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …day shift (1st or 2nd shift) is required.Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell-based products, and cleanroom ... multiple units within the CAR-T process operations (ie component preparation manufacturing , MFG support operations, Mock cell, and CAR-T process) according to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …SAP.Experience working with cell therapy is preferredKnowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell-based products is ... include material receipt, incoming inspection and release of materials required for manufacturing and release of patient material/final product of CAR-T at Raritan,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone ... The Position This position is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … compliance, clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceutical. Experience in ... resources and information from established internal contacts; consults with Supervisor/ Manager for decisions outside established processes.Provide guidance to other… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Quality Control setting is preferred. Knowledge of cGMP and GDP regulations and FDA /EU guidance related to manufacturing of cell-based products is required. ... Lab during In-Process and release Drug Product QC Testing, related to the manufacturing of cell therapy products for clinical trials and commercial operations in a… more
- Merck & Co. (Rahway, NJ)
- …and coordinating CDS technical initiatives. Supporting the clinical database manager /supervisor in project planning, manpower projections, and resource allocation ... independently, and communicate effectively. Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Manager , Manufacturing ** **Summary:** _Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI ... products including AAV and other viral vector-based therapies and vaccines._ The ** Manager , Manufacturing ** is accountable for leading teams to execute… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Manager - Manufacturing Technical Operations (MTO)** **Summary:** _Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene ... including AAV and other viral vector-based therapies and vaccines._ The **Senior Manager , Manufacturing Technical Operations (MTO)** is responsible for oversight… more
- Abbott (Atlanta, GA)
- …products covering multiple shifts comprised of supervisors, team leads, and operators. The manufacturing manager will define and lead execution of our ... a cleanroom environment. In this role will be the manager of our quickly growing manufacturing team...based on the business goals and aligned with Lean Manufacturing principles and in compliance to FDA … more
- Integra LifeSciences (Plainsboro, NJ)
- …what's possible and making headway to help improve outcomes. **SUMMARY DESCRIPTION** The Manufacturing Manager is a key member of the operations leadership team ... for Integra's Collagen Manufacturing Center (CMC) in Plainsboro, NJ. This role is...costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. +… more
- Abbott (Plymouth, MN)
- …generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Manufacturing Engineering Manager ** **Working at Abbott** At Abbott, you can ... with their lives. We are seeking an high caliber Manufacturing Engineering Manager who will be responsible...of engineering systems and procedures to ensure compliance to FDA , GMP and all other applicable agency regulations. +… more
