- Lilly (Indianapolis, IN)
- …creative solutions to support communities through philanthropy and volunteerism. **Position Summary:** The Senior Director , CMC Project Management will ... CMC scientific and technical leaders with accountability for technical deliverables. CMC Project Management is the program and project management arm of… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …alongside some of the brightest minds in biopharma. **Position Summary** The Scientific Director / Senior Director , CMC Team Leader is responsible ... into medicines. **This role may be appointed at the Director or Senior Director level.... Team Project Manager. + Accountable for CMC Project budget and applies financial acumen… more
- Lilly (Indianapolis, IN)
- …life-changing new medicines to patients who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - ... CMC commercial solid oral products will use ...strategies in collaboration with other regulatory, manufacturing, quality and project personnel to enable timely completion of submission milestones… more
- Bristol Myers Squibb (Indianapolis, IN)
- …the global leader in radiopharmaceuticals . We are seeking an experienced and motivated ** Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This ... to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility located in Indianapolis.… 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:** + ... to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee the development… more
- AbbVie (North Chicago, IL)
- …The Pharma Product Group Director will be fully responsible for providing CMC leadership and overseeing project management for both commercial and pipeline ... CMC development experience through IND and/or NDA/MAA. Experience leading multiple CMC project teams through IND and NDA/MAA preferred. + Technical… more
- Lilly (Philadelphia, PA)
- …and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the execution of multiple ... radiopharmaceutical CMC development and manufacturing programs supporting various therapeutic areas...risks and associated mitigation plans; ensure timely communication with senior management and across relevant functional areas. + Support… more
- BeOne Medicines (San Mateo, CA)
- …implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global ... throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development...product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior management. + Provides advice and drives decisions ... with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project (s), in line with… more
- UTMB Health (Galveston, TX)
- Director of Operations, - CMC - Galveston County Jail **Galveston, Texas, United States** **New** Business, Managerial & Finance UTMB Health Requisition # ... in free-world and correctional settings including benchmarking initiatives and project management. + Actively supports the conceptual design and implementation… more
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