- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is a key member in the global MSAT organization. This individual will be a program lead / owner for a best-in-class high volume marketed CAR-T product as part of a ... science, or related field Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable. Extensive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head as part ... This individual will be responsible for a global operational strategy and investigations lead / owner for a best-in-class high volume marketed CAR-T product as part… more
- 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
- Bristol Myers Squibb (New Brunswick, 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...practical aspects of global change management. **Responsibilities** Represent regulatory CMC on and/or lead matrix teams for… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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
- 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Associate Director , Business Development will seek out potential business opportunities ... efficiently communicating with excellent facilitation. The incumbent will also lead initial partnership, licensing and/or acquisition negotiations with sufficient… 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