- Daiichi Sankyo, Inc. (Bernards, 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
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop ... with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of portfolio, initiatives… more
- Merck & Co. (Rahway, NJ)
- …of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and ... tight timelines, in a rapidly changing environment.Experience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study ... and cultures. This position requires a demonstrated ability to manage/ lead people and a variety of projects concurrently. Additionally,...DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as the Associate Director , CMC Program Lead in Allogeneic Cell Therapies. You will be ... a matrix environment. This is a hybrid role. **How you will contribute:** + Lead a CMC matrix teams to deliver Cell Therapy pipeline projects and platform CMC… 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
- AbbVie (North Chicago, IL)
- …Serve as the primary Drug Product Development (DPD) representative to interface with the CMC Regulatory group. Lead CMC project teams in planning, ... to questions from regulatory authorities. + Leverage extensive drug development experience to lead the global cross-functional CMC Team in completion of global… more
- WuXi AppTec (Boston, MA)
- …drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development, and the entire manufacturing supply chain under one roof. **Please ... require bilingual language skills in Mandarin and English. **Responsibilities** + Lead all project initiation and planning efforts. Participate in the implementation… more
- Merck (West Point, PA)
- …to the Director of Packaging Commercialization, the Associate Director , Engineering, Packaging Commercialization will lead packaging development for new ... prior experience developing and commercializing new products on cross-functional teams. The Associate Director will be accountable for the definition and… more
- Otsuka America Pharmaceutical Inc. (Rockville, MD)
- **Job Summary** Associate Director , Quality Control, Biologics is responsible for late development stage through commercial biologic products including product ... scientific disciplines to drive programs through critical milestones. Collaborate with CMC teams and demonstrating ability to understand and communicate impact of… more
