- Regeneron Pharmaceuticals (Tarrytown, NY)
- …**In this role, a typical day might include the following:** + Lead CMC /CP product development activities from a regulatory standpoint during early phase, ... + Represent CMC /CP RA at program meetings and independently provide regulatory interpretation, position, and strategy for global CMC /CP portfolios covering… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... experience and 4+ years direct or related CMC regulatory experience + Successful track record in preparation, management of review and approval of NDA/MAA/BLA… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …project development preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for ... areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall ...CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The… more
- AbbVie (Florham Park, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing ... + Participate in the planning/design, conduct, analysis, and interpretation of CMC studies and regulatory submissions. Participate in establishing departmental… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Bristol Myers Squibb (Summit, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Associate Director , Cell Therapy Comparability** **Location: Summit, NJ or ... and the ability to help patients are incredible. The ** Associate Director , Cell Therapy Comparability** will lead...outcomes, conclusions, and other critical information. + Collaborate with Regulatory CMC and other key functions to… more
- Bristol Myers Squibb (Summit, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Title: Sr. Manager / Associate Director , Global Sterility Assurance CTTO** **Location: Seattle, ... BMS with our Cell Therapy team. T he **Sr Manager/ Associate Director - Sterility Assurance, Cell therapy...they apply to Cell Therapy . + Experience with regulatory inspections and CMC + Experience with… more
- Merck (Rahway, NJ)
- …the Research & Division organization of our company. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… more
- Merck (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC , formulation functions, and clinical functions to ensure ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… more
- Bristol Myers Squibb (Summit, NJ)
- …. **Position Summary:** Bristol-Myers Squibb is seeking a Product Quality Leader (PQL), Associate Director of Global Product Quality to support early development ... stage development programs (vector, gene editing and cell therapy projects) to ensure regulatory compliance of GMP operations in support of the program. The PQL must… more