- Boehringer Ingelheim (Athens, GA)
- …Analytical, Formulations, Process, Regulatory CMC , Packaging and Operations. The Technical Development Leader must work globally and cross-functionally ... **Description** The Technical Development Leader (TDL)...departmental project leaders and functional experts (as appropriate). + Lead multi-disciplinary global teams in line with Boehringer Ingelheim… more
- Eurofins (Indianapolis, IN)
- …a proactive role in the critical review of molecule specific GRA- CMC development strategies and submission content. + Makes technical decisions on CMC ... molecule/biologics drug substance/product development . + Pharmaceutical industry experience in CMC technical drug development (drug substance and/or drug… more
- Lilly (Indianapolis, IN)
- …the development of assigned product(s). Key responsibilities / expectations: + Deep technical knowledge of CMC drug development science(s) + Knowledge of ... and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC technical knowledge and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …scientific degree with directly relevant professional experience in biologics development , global CMC regulatory affairs, and CMC technical areas of at ... + Lead the execution and influence the development of global CMC regulatory strategies, including...and model Gilead's Core Values, Leadership Commitments, and People Leader Accountabilities; Embrace and comply with global CMC… more
- Sanofi Group (Bridgewater, NJ)
- …department, the GRA- CMC Small Molecules Team manages the global regulatory CMC strategy of sanofi's synthetic drugs portfolio ( development projects and ... topics with other health authorities including international with local/regional teams + Lead the Regulatory CMC content of meetings with FDA, EMA, supports… more
- AbbVie (North Chicago, IL)
- …and ensures CMC strategy is closely aligned with the clinical and regulatory development strategy. May lead multiple PPDST/ CMC teams from GLP tox through ... PDD(s) and/or develops and implements PM or training tools. Lead R&D wide or DevSci wide initiatives and strategies...from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line… more
- AbbVie (South San Francisco, CA)
- …function as a principal investigator, generating original technical ideas and development strategies + Lead development , optimization, and scale-up of ... and help drive drugs substance purification development strategy though program lead assignments in cross-functional CMC teams. This position is an onsite… more
- AbbVie (South San Francisco, CA)
- …and help drive drugs substance purification development strategy though program lead assignments in cross-functional CMC teams. This position is an onsite ... Facebook, Instagram, YouTube and LinkedIn. Job Description The Biologics CMC Development team at AbbVie in the...tools + Must be forward-thinking and be able to lead and contribute to scientific/ technical discussions and… more
- Lilly (Indianapolis, IN)
- …Registrations And Post-Approval Submissions. The Research Scientist in Global Regulatory Affairs - CMC will leverage CMC technical knowledge and Regulatory ... a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval… more
- Lilly (Philadelphia, PA)
- …**Responsibilities:** + Responsible for the generation and execution of country specific CMC regulatory strategies + Lead CMC regulatory submissions ... CMC regulatory in applicable geographies + Support CMC development projects as needed from ... CMC regulatory experience or related experience (eg CMC writer). **Additional Skills/Preferences:** + Excellent technical … more