- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...or related field. Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
- Insmed Incorporated (Bridgewater, NJ)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the… more
- Aequor (Thousand Oaks, CA)
- …chromatography, and data analytics and visualization knowledge. Job Summary: The Product Quality Director is the champion for a product team as the Product Quality ... molecule development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Quality Management Systems.… more
- Bristol Myers Squibb (New Brunswick, NJ)
- … Regulatory Sciences (GRS) and Global Product and Supply (GPS). The GRS- CMC Associate Director , Biologics will assess Manufacturing Change Controls for ... global change management. **Position Summary / Objective** The CMC Regulatory Associate Director , Biologics...and Global Product and Supply (GPS). The GRS- CMC Associate Director , Biologics will… more
- AbbVie (North Chicago, IL)
- …through regular communications and periodic reviews throughout development and in support of global filings and approvals. + Represents all CMC areas on the ... of global filings. + Responsible for the global filings of high quality CMC dossiers,...for the global filings of high quality CMC dossiers, approvals and commercialization of products. Qualifications *Bachelor's… 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 ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall … more
- AbbVie (North Chicago, IL)
- …quality and analytics is required. + Knowledge and experience with FDA and global regulatory requirements for CMC issues is required. Ability to influence ... or functions or outputs of this position. Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule… 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, ... analytical flexibility the incumbent will support "right first time" global approvals for CMC control strategies and maintain "right to operate" throughout the… more
- Teva Pharmaceuticals (West Chester, PA)
- …a difference, and new people to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee and ... Manager, Manager & Associate III). The Sr Director , Regulatory Affairs CMC is responsible for...for Teva products, and for ensuring the quality of CMC response to global health authorities. The… more
- Regeneron Pharmaceuticals (Troy, NY)
- …and made available throughout IOPS + Monitors and assesses all sources of global CMC intelligence information, including industry trends, for relevance and ... The Director of CMC Industry and Regulatory...health, environment or politics or related degree and: + Associate Director : 15+ years of related experience… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , CMC Digital Product Development where you will be ... Development team and will be a qualified DD&T leader to drive CMC digitalization technologies and endpoints across Takeda pipeline and platform activities. You… 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 ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio… more
- Bristol Myers Squibb (Devens, MA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position:** ASL Associate Director , Analytical Strategy & Lifecycle Group Lead ... **Location** : Cruiserath / Devens The Associate Director of Analytical Strategy & Lifecycle...strategies for late-stage and commercial biological products within the Global Quality organization. This leadership role will provide comprehensive… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director of Protein Production where you will be an inspirational, ... Director of the team and work with the Global Biologics organization and co-lead biologics discovery programs along...in vitro/vivo antibody discovery platforms and knowledge of downstream CMC development is essential for success. + Mentor and… 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: ... people to make a difference with. **The opportunity** Teva's Global Research & Development (R&D) organization is devoted to...process, and process tech transfer to GMP manufacturing sites. Associate Director is a key leadership role… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Lilly (IN)
- …South San Francisco, Stamford, CT, and Madrid, Spain. **Position Summary:** The Associate Director , Clinical Supply Management has responsibility for the end ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
