- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take main responsibility for … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …this role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the ... merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of...make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. As a Senior Director of Quality Assurance CMC , you will be responsible for providing ... Engineering or related fields" + 15+ years of progressive GMP/ CMC Quality Assurance experience with 7+ years...ability to inspire and motivate direct reports at the director level and below. + Ability to work independently… more
- Lilly (Philadelphia, PA)
- …+ Collaborate with global partners and external vendors to ensure timely and quality delivery of CMC activities. + Drive continuous improvement initiatives to ... and supply novel PET radiopharmaceuticals, ensuring adherence to timelines, quality standards, and cost targets. + Collaborate with cross-functional team… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic...(Dir, Sr Manager, Manager & Associate III). The Sr Director , Regulatory Affairs CMC is ... development, analytical methods, formulation development, manufacturing, and labeling. The Sr Director , Regulatory Affairs CMC ...of submissions for Teva products, and for ensuring the quality of CMC response to global health… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule where you ... CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs -...time. + Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take main responsibility for … more
- Regeneron Pharmaceuticals (Troy, NY)
- …: 18+ years of related experience regulated industry or health authority + Senior Director : 20+ years of related experience regulated industry or health ... The Director of CMC Industry and Regulatory...Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance excellence by ensuring… more
- Sanofi Group (Framingham, MA)
- … CMC by developing statistical activities, mentorship, guidance, teamwork, quality , operational efficiency, innovation and promote a productive work environment. ... 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
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Biologics Drug Product MSAT** Gilead Sciences, Inc. is ... with internal/external stakeholders. Collaborate with CMOs, Quality Control, Quality Assurance, External Manufacturing, Regulatory CMC , Process Development,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES The ... Sr Director , Analytical Regulatory Science, is responsible for supervising a...content and changes. + Evaluates and communicates risks for CMC control strategies and quality compliance to… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …managers, development program managers, medical monitors, as well as staff from quality , clinical compliance, regulatory, formulations, and IOPS ( CMC , external ... The ** Sr Manager, Clinical Drug Supply & Logistics** is...are performed on time, within budget and with good quality , in compliance with Regulatory Authorities' regulations / guidelines… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring … more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Purification Process Development - Pivotal & Commercial ... Biologics** The Senior Director of Purification Process Development for...control strategy in partnership with organizations across Technical Development, Quality , Regulatory Affairs CMC , and Manufacturing. +… more
- Lilly (South San Francisco, CA)
- …life better for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs, Global Regulatory Lead ... and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC , GRA-Devices, and regional regulatory scientists) and is responsible for forming… more
- BeiGene (Emeryville, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... functional leadership (including but not limited to clinical Operation, Quality , Regulatory, CMC , and GRDS) to ensure alignment of organizations and prompt… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director , PDM Product Strategy Leader for Established Products** **KEY ... outcome-oriented team leadership in some aspects of pharmaceutical manufacturing, supply chain, quality , CMC regulatory, or process development, or as a member… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …bio-analytics, and formulation research and development, as well their knowledge of quality systems and formal CMC (Chemistry, Manufacturing and Controls), to ... partners. You will be a member of the VD&S CMC Domain and report to the Deputy Director...insightful written analyses and recommendations for funding. + Provide senior -level technical CMC expertise for internal Program… more
- Novo Nordisk (Lexington, MA)
- …lives for a living. Are you ready to make a difference? The Position The Senior Director can be accountable for the Clinical pharmacology strategy for phase 1-4 ... Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop… more
- BeiGene (San Mateo, CA)
- …Provide the performance metrics information to CMO vendor management team and escalate any quality or compliance issue timely to senior management when needed. + ... functionally and collaboratively in BeiGene with eg Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU. + Provide quality … more
