- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The project ... based on the project needs and the respective development stage of the project . The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the ... as point of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with supervision. Prepares… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... portfolio biologics and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change implementation.… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director , Alliance Management.Tris Pharma has a long track record of ... spanning many departments across all stages of the product lifecycle. The Associate Director , Alliance Management will be accountable for managing alliances… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of portfolio, initiatives… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Affairs CMC where you will develop ... CMC team, you will report to a Senior Director and work with stakeholders across the business. **How...regulations. Assures conformance with Takeda controlled procedures and GRA CMC best practices. + Ensure project team… more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global ... of country specific CMC regulatory strategies + Lead CMC regulatory submissions including overall submission project , cross-functional communication,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The project ... based on the project needs and the respective development stage of the project . The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage … more
- AbbVie (North Chicago, IL)
- …interface with the CMC Regulatory group. Develop standard processes and lead CMC project teams in planning, preparation, review and approval of drug ... with CMC Regulatory and Process R&D. + Partner with CMC Regulatory to assist CMC project teams in identifying submission-related risks and develop… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the ... Acts as point of contact to cross-functional teams on US/EU RA CMC project issues. + **Execution of Strategy and Submissions:** Develops strategy with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with product development, ... + Works with CMC RA Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks. + Demonstrates… more
- Regeneron Pharmaceuticals (Troy, NY)
- …preferably related to health, environment or politics or related degree and: + Associate Director : 15+ years of related experience in regulated industry or ... The Director of CMC Industry and Regulatory...Strong communication skills, both oral and written. + Strong project management leadership skills essential + Good understanding of… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing ... areas with a focus on Chemistry, Manufacture and Control ( CMC ), expanding and broadening the application of Biostatistics. He/she...or seeking help from others + Able to manage project timeline and quality of deliverables + Able to… 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...cultivating vendor relationships + Supervising third-party activities and delivering project updates with recommendations Traits we believe make a… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... portfolio biologics and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change implementation.… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **Objective / Purpose:** + Global CMC program oversight of PS with management of all project -related analytical ... line function strategies, program managements, resources, and budgets + Local CMC program oversight related to analytical development, testing, and characterization,… more
- Bristol Myers Squibb (Summit, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Associate Director , Cell Therapy Comparability** **Location: Summit, NJ or ... your career, and the ability to help patients are incredible. The ** Associate Director , Cell Therapy Comparability** will lead comparability programs and… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Ensures timely preparation of organized and scientifically valid… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... dynamic and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your...Proposal (RFP) through contract execution for clinical studies and CMC projects as well as ongoing governance with key… more
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