- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , CMC Digital Product Development where you will be tasked with ... Engineering, and the Emerging Technologies team to help digitize our process development , analytical development , and manufacturing work flows and enable… more
- AbbVie (North Chicago, IL)
- …with respect to science, time, budget and resources. + Develops and implements a CMC product development plan and updates as necessary in collaboration ... thinking and make smart business decisions. *Ensure high level of morale in the CMC team. Product development experience of leading a CMC team through… more
- AbbVie (North Chicago, IL)
- …technology, quality, regulatory/compliance requirements, budget and resources. *Multiple product development experiences of leading a CMC team through IND ... from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line...needed. + Critically evaluates and integrates drug substance, drug product , and device inputs to CMC team… more
- AbbVie (North Chicago, IL)
- …experience; PhD Degree with at least 10+ years of relevant experience. + CMC development experience through IND and/or NDA/MAA/BLA. Experience leading multiple ... about the accountability and scope. + Lead cross-functional PDS&T product teams and represent the CMC team...Bachelor 's Degree with 14+ years of relevant experience ( CMC , sterile manufacturing/ development ); Master's Degree with 12+… more
- Teva Pharmaceuticals (West Chester, PA)
- … Director , Regulatory Affairs CMC is responsible for identifying and evaluating CMC issues associated with product development including product ... formulation development , manufacturing, and labeling. The Sr Director , Regulatory Affairs CMC is also responsible...regulatory departments. The Sr Director , Regulatory Affairs CMC will oversee cross functional product teams… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Read more: careers.bms.com/working-with-us . The CMC Regulatory Associate Director , Biologics is responsible for content development , compilation, ... and Global Product and Supply (GPS). The GRS- CMC Associate Director , Biologics will assess Manufacturing...Summary / Objective** The CMC Regulatory Associate Director , Biologics is responsible for content development ,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ A scientific degree with directly relevant professional experience in small molecule product development , global CMC regulatory affairs, and CMC ... countries worldwide, with headquarters in Foster City, California. **Sr Director , CMC Regulatory Affairs -Small Molecules** **KEY...of CMC RA colleagues to drive global CMC regulatory strategy development for a portfolio… more
- Takeda Pharmaceuticals (Boston, MA)
- …organization to think proactively and utilize science and risk based approach to product development and LCM activities. + Contribute to creating and ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule...Pharmaceuticals. **How you will contribute:** + Leads the Early Development Pharmaceuticals GRA CMC regulatory team in… more
- Editas Medicine (Cambridge, MA)
- …including but not limited to developing regulatory strategy and plan for CMC development , assessing regulatory scenarios risks and opportunities, proposing risk ... functional teams to provide regulatory guidance and support for CMC development and ensure compliance with applicable...is preferred. + A broad understanding of the drug product development process is required. + This… more
- Lilly (Philadelphia, PA)
- …standards, and cost targets. + Collaborate with cross-functional team leaders, including development , CMC regulatory, manufacturing, and supply chain teams, to ... radiopharmaceutical development and manufacturing and incorporate them into the CMC strategy. + Mentor and develop team members, providing coaching and feedback… 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. In case ... early and late phase drug development candidates within the team to support overall CMC development plan. - Represent CMC development project teams… more
- AbbVie (North Chicago, IL)
- …respect to time and budget. + Serve as the primary Drug Product Development (DPD) representative to interface with the CMC Regulatory group. Develop standard ... the clinical/regulatory development strategy and provide drug development experience and advice to the CMC ...planning, preparation, review and approval of drug substance, drug product and analytical sections of CMC submission… 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
- BeiGene (Emeryville, CA)
- …cell therapy development . Ideal candidate must be proficient in both CMC strategic planning, execution, and matrix team management. The successful applicant will ... cell therapies is a plus. + Broad understanding of all aspects of CMC including process development , regulatory and quality requirements, analytical … 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 ... regulations. More specifically, the individual will work with the global cross-functional CMC team executing late-stage development in support of Phase III… more
- Gilead Sciences, Inc. (Foster City, CA)
- …The Associate Director , Analytical Regulatory Science, collaborates with product development , manufacturing and quality teams on the construction, ... member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Drug Product Development ...from IND through BLA filing. Drug Product Development (DPD) is a function within Biologics CMC ... of biologics. The rapidly growing staff of Biologics CMC specializes in the development of innovative...The Associate Director is responsible for drug product development for Teva biologics products to… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …populations in Low Income Countries. + Apply comprehensive knowledge and demonstrated expertise in CMC product development to advise internal teams and work ... Deputy Director of Chemistry, Manufacturing and Controls ( CMC ) to join our Integrated Development (IDev)...related discipline + Minimum of 15 years' experience in CMC product development in the… more
- AbbVie (North Chicago, IL)
- …operational excellence within Biologics Analytical R&D and in line with the Biologics CMC Development /AbbVie strategy for NBEs. + Recruit, promote, and retain ... interfaces with other functions inside and outside of Biologics CMC Development and R&D. + Assures compliance...experience in leading a biologics drug substance and/or drug product development organization across different levels and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …is responsible for supervising a team of scientists, who collaborate with product development , manufacturing and quality teams on the construction, documentation ... team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our...control strategies and maintain "right to operate" throughout the product lifecycle. In addition, the Sr Director … more