- 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
- Taiho Oncology (Pleasanton, CA)
- Director , Regulatory Affairs CMC Pleasanton, CA, USA Req #355 Tuesday, March 26, 2024 Looking for a chance to make a meaningful difference in the oncology space? ... and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly...Inc., (TOI) projects; provides strategic regulatory guidance especially for CMC during drug development , approval and post… more
- Lilly (Indianapolis, IN)
- …strategy based upon global regulatory changes. + Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development ... + Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content. + Makes decisions on CMC… 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 ... CMC experience including experience as an RA CMC product lead, or equivalent industry experience,...Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred. +… 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
- 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 (Indianapolis, IN)
- …and evolving global regulatory expectations + Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development ... + Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content + Makes risk-based decisions on… 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
- BeiGene (San Mateo, 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
- 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
- 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 ... 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
- Merck (North Wales, PA)
- …pulse on all programs within the vaccines portfolio + Able to independently manage CMC development projects of any type, including those which require extensive ... and building a new team. Reporting to the Executive Director of CMC Integrated Project Management, the...input into improvements to processes / templates that support product development or project management. **Talent … 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
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** **Senior Director , Biologics Drug Product MSAT** Gilead Sciences, Inc. is a ... Collaborate with CMOs, Quality Control, Quality Assurance, External Manufacturing, Regulatory CMC , Process Development , Supply Chain and other functional areas.… more
- Lilly (Indianapolis, IN)
- …partnerships with Discovery, Manufacturing, and external entities, that are vital for product development and integration of new technologies. + Provide ... is a must have. Demonstrated competency, experience, and knowledge in biologics CMC development and compliance requirements from early to late clinical phase… more
- Lilly (Indianapolis, IN)
- …**Additional Skills and Preferences** + Extensive experience in parenteral drug product process development . + Deep understanding of parenteral manufacturing ... effective processes and practical products. + Background encompasses manufacturing process development of parenteral drug product , including oligos, protein,… more