- 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)
- …products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global R&D. **Position Overview:** Sanofi's global ... (GRA) function is comprised of more than 1800 people. The Device Regulatory Lead for Specialty Care & Vaccine Combination Products will oversee key regulatory… 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 (West Point, PA)
- …Health, Process Development, Commercialization, Operations, Technical Operations, Analytical, Quality, Regulatory- CMC , and Supply Chain. Associate Director ... **Job Description** **Position Description:** ** Associate Director ,** **Technology Transfer** **(TT)** **Systems...Technology Transfer within Technical Product Leadership. This role will lead a team of scientists and engineers with a… more
- AbbVie (Madison, NJ)
- …with multiple driver indications within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director , or Director , in the ... timely response to Health Authorities during application review. . Support CMC sections of major, complex regulatory submissions, including Investigation New Drugs… 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