- Boehringer Ingelheim (Ridgefield, CT)
- …a highly skilled and experienced Director to join our External Alternative CMC Development (EACD) team. The ideal candidate will have expertise in drug ... collaborations with Contract Development and Manufacturing Organizations (CDMOs). The Director will support all drug product-related CMC activities within… more
- Boehringer Ingelheim (Ridgefield, CT)
- …position can support projects of increasing regulatory complexity and/or business impact. The Senior Associate Director , US Product CMC Regulatory Affairs is ... relevant topics. Additionally, with support and guidance from the Sr . Associate Director / Director ,...DMF Annual Report on behalf of the DMF Holder. CMC Development : + Provides US CMC… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages ... strategies for both development and commercial products. Additionally, the Senior Director is committed to fostering continuous improvement in regulatory… more
- Takeda Pharmaceuticals (Lexington, MA)
- …proficient understanding of scientific principles and profound grasp of global regulatory CMC requirements relevant to global drug development and post-market ... This role is within in the R&D GRA Chemistry Manufacturing & Controls ( CMC ) and Devices organization, and will contribute to the team's delivery of critical… more
- BeOne Medicines (Harrisburg, PA)
- …of relevant pharmaceutical or biopharmaceutical industry experience in innovative drug CMC development , manufacturing, Quality, etc. including minimum 8 years ... team in US. * Lead or/and oversee the development and implementation of biologics regulatory CMC ...needed throughout product lifecycle. Escalate the critical issues to senior management timely. * Lead or/and oversee the establishment… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or to the governance bodies. **Responsibilities** - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. ... respective development stage of the project. The CMC Lead will support the Sr . ...and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status… more
- Merck (North Wales, PA)
- …+ Industry / regulatory experience in pharmaceutical or combination product research, development and/or manufacturing + Experience with CMC regulatory where ... Description** This Associate Principal Scientist position is equivalent to an Associate Director position. Under direction from a Director , the Associate… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Digital Product Owner (Associate Director / Senior Manager) In Silico CMC **Location:** Cambridge, MA, Framingham, MA or Morristown NJ **About ... faster and more efficiently. As an Associate Director / Senior Manager Product Owner for in silico CMC...company is a strong plus + Knowledge of software development for chemistry applications is a plus **Key skills:**… more
- Lilly (Indianapolis, IN)
- …development cycle (proof of concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is expected ... life better for people around the world. The Synthetic Molecule Design and Development (SMDD) is responsible for the development of synthetic drug substances… more
- Lilly (Indianapolis, IN)
- …to enable faster delivery of significant technical agendas. The Sr . Director leads cross functional manufacturing/quality peers and senior management teams ... for people around the world. **Position Brand Description:** The Sr . Director Portfolio Management role is responsible...degree + Experience with and the knowledge of the CMC aspects of drug development and manufacturing… more