- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge...experience and 4+ years direct or related CMC regulatory experience + Successful track record… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager / Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… more
- Bristol Myers Squibb (Devens, MA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Sr. Manager / Associate Director, Global Sterility Assurance CTTO** **Location: ... BMS with our Cell Therapy team. T he **Sr Manager / Associate Director - Sterility Assurance, Cell therapy...they apply to Cell Therapy . + Experience with regulatory inspections and CMC + Experience with… more
- Schrodinger (Cambridge, MA)
- We are looking to hire a **Senior Manager / Associate Director of Clinical Pharmacology** to join us in our mission to discover and develop drugs that improve ... stakeholders including DMPK, translational medicine, clinical development, clinical operations, regulatory , CMC , and project management to ensure completion… more
- BeiGene (Emeryville, CA)
- **General Description:** The Associate Manager of Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and ... and provide a high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC ). + Work with Clinical Operations to understand… more
- Novo Nordisk (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- CSL Behring (King Of Prussia, PA)
- …knowledge in drug research, development and manufacturing processes of pharmaceuticals ( CMC , non-clinical, clinical, and regulatory ).** **Expert level skillset ... used to treat serious and often rare conditions. Could you be our next Associate Director, R&D Project Planning Capability Lead? This position is located in our King… more
- Merck (North Wales, PA)
- …the Research & Division organization of our company. **Position Description/Summary:** The GPAM Associate Director, Project Manager , is a core member of Early ... **Job Description** The drug development Project Manager is part of Global Project and Alliance...strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …our team, **Biologics Pre-Pivotal Formulation and Process Development** , as an ** Associate Scientist** . The successful candidate will contribute to the development ... documentation practices. . Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and… more
- IQVIA (Durham, NC)
- …ancillary supply related questions in close collaboration with the Ancillary Support Associate (ASA)/ Site Manager (SM). + Develop IP administration training ... Investigational Product Specialist, Site Investigational Product Specialist, Ancillary Support Associate , Independent Drug Monitor Manager , Independ ent Drug… more