- Boehringer Ingelheim (Ridgefield, CT)
- …currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at ... activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate Director of EACD for drug… more
- Lilly (Philadelphia, PA)
- …new medicines, and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the ... on-site at the Philadelphia office. **Responsibilities:** + Serve as the CMC Lead for one or more development assets, ensuring integrated planning, execution,… more
- AbbVie (North Chicago, IL)
- …assure timely impact assessment, and implementation of new regulatory requirements. Will lead CMC Coordination activities for later stage and more complex ... interface with the CMC Regulatory group. Develop standard processes and lead CMC project teams in planning, preparation, review and approval of sections of … more
- BeOne Medicines (San Mateo, CA)
- …and process optimizations on relevant topics. **Essential Functions of the job:** + Lead , develop and implement small molecule CMC regulatory strategies as well ... CMC regulatory strategies for the assigned projects. + Lead regulatory risk assessment, identify key CMC ...+ Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Associate Director - CMC BioDPDM **Location**...MA As Associate Director within CMC BioDPDM, you'll have the opportunity to lead ... could turn the impossible into possible for millions. The Associate Director role is a key leadership...Director role is a key leadership role in CMC Biologics Drug Product Development and Manufacturing. You will… more
- Organon & Co. (Jersey City, NJ)
- …**The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible for developing and implementing ... with global regulations and guidance, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers… more
- Sumitomo Pharma (Lincoln, NE)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy,… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** GRA Device Lead ( Associate Director ) -...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The ... Digital Health **Location:** Cambridge, MA/ Morristown, NJ **About the Job** GRA Device Lead ( Associate Director ) - Digital Health Are you ready to shape the… more
- AbbVie (North Chicago, IL)
- …and efficient operations and maintenance of AbbVie's automated laboratory systems. Lead the daily operation of automation capabilities through continuous systems ... automation systems strategy and roadmap in alignment with department objectives and SM CMC R&D strategies. . Develop and revise project plans and budgets, work with… more
- Otsuka America Pharmaceutical Inc. (Boise, ID)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... drug product at CDMOs + Design and lead method validation and implementation activities for drug substance and drug product ensuring compliance with relevant ICH and… more