- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC ... based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Device Regulatory Lead ( Associate Director )** + Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global ... team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global R&D. This critical...get started? **Main responsibilities** + Serve as Device Regulatory Lead on assigned project teams (early phase, late stage… more
- J&J Family of Companies (Spring House, PA)
- Associate Director , Cell Therapy Decisional Analytics - 2406185128W **Description** Johnson & Johnson is recruiting an Associate Director , Cell Therapy ... We are looking for an energetic and highly motivated Associate Director candidate with demonstrated expertise in...and lentiviral vector process development. The successful candidate will lead a team focused on the development and rapid… more
- Merck (North Wales, PA)
- **Job Description** **Position Description:** ** Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease** The Regulatory Affairs ... Headquarters Associate Principal Scientist supports products in the Vaccine and...reports. The individual may also assist or take the lead in tracking, authoring, shepherding and/or review of responses… more
- Merck (West Point, PA)
- …of vaccine and biologic drug substances (DS) as the Executive Director for the Bioprocess Clinical Manufacturing & Technology (BCMT) organization, based ... GMP manufacturing. The individual will report directly to the Associate Vice President of VAX Process R&D and will...in preparation for production; and collaborate with Manufacturing and CMC Regulatory in the preparation of regulatory filings for… more
- Merck (West Point, PA)
- …process development and manufacturing of vaccine drug substances (DS) as an Executive Director for Discovery Interface & New Platforms (DINP), located in West Point, ... manufacturing for all of our company's pipeline. The Executive Director will be responsible for interfacing with our Discovery...leading conferences. The individual will report directly to the Associate Vice President, of VAX Process R&D and will… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …as staff from quality, clinical compliance, regulatory, formulations, and IOPS ( CMC , external manufacturing, stability). **A typical day might include the ... following:** + Serves as lead drug supply manager of a program and/or individual...and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity and/or handles any/all aspects… more