- Bristol Myers Squibb (New Brunswick, NJ)
- …attributes, statistics, risk assessment approaches, and cGMP principles. + Basic knowledge of regulatory requirements for the CMC dossier for regulatory ... of drug candidates through appropriate formulation strategies. + Support preparation of CMC regulatory documents. + Support departmental initiatives for assigned… more
- Sanofi Group (Framingham, MA)
- **Senior Scientist , Upstream MSAT** **DEPARTMENT DESCRIPTION** : The Senior Scientist position is part of the Upstream team in the Recombinant Drug Substance ... The function is responsible for tech transfer, process validation, dossier preparation, & PAI support to enable launch of...department and as the Upstream representative on technical product, CMC , and technology transfer teams. + Contribute to or… more
- Sanofi Group (Waltham, MA)
- …accurate assessments are made for decision-making, while ensuring compliance with regulatory expectations. As a core objective, his/her responsibilities include but ... in preclinical development plan, decision-making meetings, integrated analyses and dossier preparation, submission (IND and CTD) and follow-up (publication), +… more