- 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)
- … development of assigned product(s). **Key responsibilities / expectations:** + Deep technical knowledge of CMC drug development science(s) + Knowledge ... and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC technical knowledge and… 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …on drug-device combination regulatory strategies in regulatory filings through clinical development and commercial product lifecycle + Lead regulatory strategy, ... How you will contribute: **OBJECTIVES:** + Leadership in for the development and implementation of innovative pure device and combination product regulatory… 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
- 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
- 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
- Lilly (Indianapolis, IN)
- …for cross-functional CMC teams for programs of moderate complexity. + Lead the creation, development , communication and implementation of integrated CMC ... team(s) and will partner closely with the scientific and technical leaders of the CMC team, who...clinical, asset and portfolio strategy into clear CMC development and delivery goals… more
- J&J Family of Companies (Columbus, OH)
- …for. + Provides regulatory and technical expertise and input to the CMC team to facilitate successful product development globally + Leads the preparation ... regulatory dossiers for submission to Health Authorities. + Provides technical expertise and technical input in the...issues to Management **Sphere of Authority** + Ensures the CMC development and commercial product regulatory strategy… more
- Lilly (Philadelphia, PA)
- …**Responsibilities:** + Responsible for the generation and execution of country specific CMC regulatory strategies + Lead CMC regulatory submissions ... people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the... CMC regulatory in applicable geographies + Support CMC development projects as needed from … more
- AbbVie (North Chicago, IL)
- …experience; PhD Degree with at least 10+ years of relevant experience. + CMC development experience through IND and/or NDA/MAA. + Experience leading multiple ... Lead cross-functional S&T product teams and represent the CMC team and/or S&T in interface with S&T leadership,...and maintain comprehensive project plans, budgets, timelines and strategy; technical projects at all stages of development … more
- Organon & Co. (Plymouth Meeting, PA)
- …and/or coordinate with Regulatory CMC scientists in the Organon franchise teams. + Lead development and execution of regulatory CMC strategies to ensure ... of approval of all regulatory submissions. This includes assessing CMC changes during development and defining regulatory...are in place to maintain the quality of scientific, technical and regulatory information within CMC submissions,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and supplements/variations with limited management supervision. + Represent Regulatory Affairs (RA) CMC on product development and life-cycle management teams to ... team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our...and manages content of pre-meeting submissions with little RA CMC management support. + Analyze and interpret technical… more
- Takeda Pharmaceuticals (Boston, MA)
- …How you will contribute: **OBJECTIVES:** + Responsible for the development and implementation of innovative device and integral/co-packaged combination product ... regulatory strategies for development , registration, commercialization and life cycle management of assigned...+ For US and with a global mindset, utilizes technical combination product knowledge, regulatory expertise and global regulatory… more
- BeiGene (San Mateo, CA)
- …Escalate critical issues to senior management. + Lead or contribute to development of internal regulatory CMC guidance, SOPs, and work instructions. + Ensure ... consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory… more
- Sanofi Group (Waltham, MA)
- …cutting-edge mRNA technology! **About the Opportunity** As an experienced mRNA Process CMC Principal Statistician, you will lead and coordinate the statistical ... end to end data integration and advanced analytics (pre-clinical, biomarkers, process development , CMC , clinical) in the mRNA CoE. Deploying and exploiting… more
- Gilead Sciences, Inc. (Foster City, CA)
- …People Leader Accountabilities. + May participate in business process development initiatives or represent the company in industry consortia. **Qualification** + ... team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our...direct impact. We believe every employee deserves a great leader . People Leaders are the cornerstone to the employee… more
- Takeda Pharmaceuticals (Boston, MA)
- …Description** Takeda Development Center Americas, Inc. is seeking an Associate Director, CMC Program Lead , Cell Therapies in Cambridge, MA with the following ... productivity and product quality improvement in Chemistry, Manufacturing & Control ( CMC ) processes; Employ technical project management principles (project… more
- GE Aerospace (Evendale, OH)
- …**Roles and Responsibilities** + Advance technology and manufacturing readiness levels for CMC raw material processes and equipment. + Lead and execute ... Summary** The engineer will be a member of the Ceramic Matrix Composite ( CMC ) and Environmental Barrier Coating (EBC) materials and processing team whose mission is… more