- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing ... serve as G-RACMC lead or regional submission lead . Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams… more
- Bristol Myers Squibb (Princeton, NJ)
- …(including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS- CMC Associate Director , Biologics will serve as the ... Sciences (GRS) and Global Product and Supply (GPS). The GRS- CMC Associate Director , Biologics will...of global change management. **Position Responsibilities** + Represent regulatory CMC on and/or lead matrix teams for… more
- WuXi AppTec (Philadelphia, PA)
- …projects, ensuring timely and high-quality delivery **Responsibilities** * Provide analytical CMC -related support for new working order signing at BD, participate in ... aspect of the project: identify analytical technical challenges and takes the lead in crossfunctional teams to address these challenges, aligns technical solutions… 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
- Sumitomo Pharma (Trenton, NJ)
- ** Associate Director , FP&A** Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need ... highly motivated, and experienced individual for the position of ** Associate Director , FP&A.** Position serves as a...T&Q organization, including VPs in Manufacturing, Quality, Supply Chain, CMC , and CPC, as it relates to Operating Expense… more
- Merck (West Point, PA)
- …Our Company is seeking a highly motivated candidate for the position of Director , Vaccine Drug Product Development. Vaccine Drug Product Development (VDPD) team is ... of vaccine drug products and various innovative technology platforms. The candidate will lead and direct the development for a range of vaccine modalities within our… more
