- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The CMC Regulatory Associate Director , Biologics is responsible ... practical aspects of global change management. **Position Summary / Objective** The CMC Regulatory Associate Director , Biologics is responsible for… more
- Teva Pharmaceuticals (West Chester, PA)
- …with 4 direct reports (Dir, Sr Manager, Manager & Associate III). The Sr Director , Regulatory Affairs CMC is responsible for identifying and evaluating ... Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun 13, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with ... be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory...health, environment or politics or related degree and: + Associate Director : 15+ years of related experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, ... serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams… more
- AbbVie (North Chicago, IL)
- … CMC activities with respect to science, technology, quality, regulatory /compliance requirements, budget and resources. *Must possess good scientific writing ... matrix management approach; Key member of Asset Strategy Team (AST) and ensures CMC strategy is closely aligned with the clinical and regulatory development… more
- AbbVie (North Chicago, IL)
- …issues is required. Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence in writing, ... or functions or outputs of this position. Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule… more
- Sanofi Group (Framingham, MA)
- …to process development activities. + Broad knowledge of (bio)pharmaceutical development and CMC activities in a regulatory context, including good understanding ... discovery and development to find answers for patients and their families. The CMC -Biologics Statistics team is seeking an expert data scientist / Statistician to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …project development preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for ... areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall ...CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Principal Scientist/ Associate Director , CMC Development located at our South San Francisco ... 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Sanofi Group (Cambridge, MA)
- **Job title: Device Regulatory Lead ( Associate Director )**...of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and ... PA or Cambridge, MA **About the job** The Global Regulatory Affairs Device team is a globally diverse team...territories that need "new" thinking and approaches from a regulatory perspective. You will be expected to proactively initiate… more
- Bristol Myers Squibb (Devens, MA)
- …standards, and comparability studies. In addition, the ASL Associate Director will be accountable for enabling regulatory filings (analytical related), ... in their personal lives. Read more: careers.bms.com/working-with-us . **Position:** ASL Associate Director , Analytical Strategy & Lifecycle Group Lead… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Drug Product Development Date: May 24, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: ... process, and process tech transfer to GMP manufacturing sites. Associate Director is a key leadership role...to progress biologic products. + Experience authoring and reviewing regulatory submissions related to CMC activities. +… more
- J&J Family of Companies (Spring House, PA)
- Associate Director , Autologous Cell Therapy Process Development - 2406176241W **Description** Johnson & Johnson is currently seeking an Associate Director ... energetic and highly motivated candidate for the role of Associate Director , who possesses proven expertise in...and gene therapy processes + Previous experience in preparing CMC documents to support regulatory filings for… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …New Modality) team. - Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …professionally to achieve your own career goals. **Job** **Title:** Scientific Associate Director **Location:** New Brunswick **Division:** Global Production & ... at all microbiological testing locations in the BMS network. The Scientific Associate Director will also ensure appropriate strategies for DP-related… more
- Lilly (IN)
- …South San Francisco, Stamford, CT, and Madrid, Spain. **Position Summary:** The Associate Director , Clinical Supply Management has responsibility for the end ... team members across functions including but not limited to clinical operations, CMC , regulatory affairs, and QA. + Working knowledge of cGMP's (CFR/ICH) and GCP… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Associate Director of Drug Substance - EACD will have the primary responsibility to oversight process development and manufacturing ... of clinical/commercial stage small molecule APIs. Reporting to the Director of EACD, this individual will provide guidance to...+ Serve as the drug substance technical lead on CMC teams and coordinate activities with regulatory ,… more
- Novo Nordisk (Boulder, CO)
- …are driving change. Are you ready to make a difference? The Position The Associate Director , Process Chemistry will be responsible for the design, development ... in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical...scaling of small molecules, oligonucleotide intermediates and API's. The Associate Director is expected to implement novel… more