- Merck (Rahway, NJ)
- **Job Description** **Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5)** Under general supervision of an Executive Director/ Senior ... with domestic and international regulations and guidance. The Principal Scientist is responsible for the leading the preparation and...but are not limited to: + Serve as a Regulatory CMC Project Lead and provide … 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)
- …**Summary** The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the ... 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)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Position:** Senior Scientist **Location** : Summit, New Jersey **Business Unit ... uncommon in scale and scope. **Position Summary** As a Senior Scientist , the selected candidate will be...to drug product development. + Experience in building the CMC dossier for regulatory submissions within the… more
- Bristol Myers Squibb (Summit, NJ)
- …uncommon in scale and scope. **Position Summary** Bristol Myers Squibb is seeking a Senior Scientist to join the Oral Product Development group within the Drug ... of drug candidates through appropriate formulation strategies + Support preparation of CMC regulatory documents + Support departmental initiatives for assigned… more
- ThermoFisher Scientific (New Brunswick, NJ)
- …biopharmaceutical company, all while maintaining full-time benefits. **Key responsibilities:** As a Senior Scientist , you will be part of the Analytical ... Participates in the preparation and the critically review of regulatory filings including evaluation of data from collaborator labs.... inspections. + Effective teamwork and communication with the CMC sub teams to ensure all API and drug… more
- Merck (Rahway, NJ)
- …of connectivity between the functions supporting the pipeline (ie quality, regulatory , clinical development; chemistry, manufacturing, and control ( CMC ); supply ... **Job Description** **Principal Scientist Job Description** The Materials and Biophysical Characterization...higher order structure of biotherapeutics. As part of the CMC development team,, you will be leading and/or supporting… more