- Lilly (Philadelphia, PA)
- …standards, and cost targets. + Collaborate with cross-functional team leaders, including development , CMC regulatory, manufacturing, and supply chain teams, to ... development and manufacturing and incorporate them into the CMC strategy. + Mentor and develop team members, providing...budget, and resource allocation, and provide regular updates to senior management. + Lead other tasks / projects as… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California. ** Sr Director , CMC Regulatory Affairs -Small Molecules** **KEY ... RESPONSIBILITIES** The Sr Director , CMC Regulatory Affairs for Small Molecules...of CMC RA colleagues to drive global CMC regulatory strategy development for a portfolio… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. As a Senior Director of Quality Assurance CMC , you will be responsible ... specifically, the individual will work with the global cross-functional CMC team executing late-stage development in support...ability to inspire and motivate direct reports at the director level and below. + Ability to work independently… more
- Teva Pharmaceuticals (West Chester, PA)
- …development , analytical methods, formulation development , manufacturing, and labeling. The Sr Director , Regulatory Affairs CMC is also responsible for ... Senior Director Regulatory Affairs CMC (Biologic...(Dir, Sr Manager, Manager & Associate III). The Sr Director , Regulatory Affairs CMC is… more
- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is ... operate" by maintaining the global licensures. In addition, the Sr Director will be accountable for leading...and Skills** + Lead the execution and influence the development of global CMC regulatory strategies, including… 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 -...Pharmaceuticals. **How you will contribute:** + Leads the Early Development Pharmaceuticals GRA CMC regulatory team in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or to the governance bodies. **Responsibilities** - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. ... respective development stage of the project. The CMC Lead will support the Sr . ...and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status… 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...development and commercialization process, with a focus on CMC + Experienced in understanding and interpreting regulatory guidelines… more
- Sanofi Group (Framingham, MA)
- …to support the CMC activities for process, analytical methods and formulation development , in the US, across our Boston area sites. Your skills could be critical ... applied to process development activities. + Broad knowledge of (bio)pharmaceutical development and CMC activities in a regulatory context, including good… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …positioning, creative campaign development and regional alignment/coordination). The Senior Director , Global Launch Readiness Immunology will be responsible ... Sr Director , Global Launch Readiness -... and commercialization program with an outside partner. The Senior Director will be the Teva commercial… 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 ... Collaborate with CMOs, Quality Control, Quality Assurance, External Manufacturing, Regulatory CMC , Process Development , Supply Chain and other functional areas.… 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 ... team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our...Sr Director , Analytical Regulatory Science, is responsible for supervising a… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The ** Sr Manager, Clinical Drug Supply & Logistics** is responsible for providing oversight of individual or multiple clinical programs, forecasting Investigational ... and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, as well as staff from quality,… more
- Integra LifeSciences (Plainsboro, NJ)
- …regulatory agencies. **SUPERVISION RECEIVED** Receives minimal supervision from the Director , CMC Quality Operations. **SUPERVISION EXERCISED** Manages personnel ... challenging what's possible and making headway to help improve outcomes. This ** Senior Manager, Quality Operations** will manage and provide oversight on Quality… more
- Gilead Sciences, Inc. (Foster City, CA)
- …fulfil 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 Pivotal...with cross-functional stakeholders and contribute to the overall biologics CMC development strategies. **Responsibilities:** + Hire, mentor… more
- Editas Medicine (Cambridge, MA)
- …and distribution of non-GMP materials at all locations. Key Responsibilities: As the Sr . Director , Supply Chain, you will be responsible for: + Building ... and Technical Operations and partner with leadership in TechOps, ClinOps, Finance, CMC and Program Teams to lead short-term integrated production and raw materials… 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 ... leadership (including but not limited to clinical Operation, Quality, Regulatory, CMC , and GRDS) to ensure alignment of organizations and prompt resolution… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …translating regulatory requirements into practical, workable plans to facilitate timely drug development and registration. The Senior Director , Regulatory ... diseases, researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical, may be called upon to… more
- Novo Nordisk (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 ... About the Department Our East Coast Global Development Hub brings together the best minds in...a difference? The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific… 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 ... About the Department Our East Coast Global Development Hub brings together the best minds in...Global Translation, Global Medical Affairs, Global Safety (GS), Bioanalysis, CMC and occasionally with leadership in Medical and Science… more