- 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
- 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 ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...small molecule pipeline. Your responsibilities will include driving the development and manufacturing of drug substances, overseeing both internal… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …This position makes decisions with consultation. **Responsibilities:** + **Planning for Development :** Manages multiple CMC development projects. ... organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves as ad… more
- Takeda Pharmaceuticals (Boston, MA)
- …part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...oversee the development and execution of regulatory CMC development and registration strategies. RA … more
- Lilly (Philadelphia, PA)
- …requirements applicable to CMC regulatory in applicable geographies + Support CMC development projects as needed from CMC regulatory perspective ... for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for...maintain tools to effectively communicate the status of ongoing CMC regulatory projects to cross-functional teams and senior… 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
- Frontier Medicines (South San Francisco, CA)
- Frontier Medicines is seeking a highly motivated individual for a newly created Director / Senior Director role in Process Chemistry in Frontier's South San ... equipment, and scale-up challenges + In collaboration with the Development Project Lead and/or CMC Head, define...collaboration with the Development Project Lead and/or CMC Head, define timelines, production scale, and budget to… more