- Amgen (Washington, DC)
- …Join us and transform the lives of patients while transforming your career. Senior Director , CMC Statistics **What you will do** Let's do this. Let's change ... Amgen's pipeline and commercial products across different therapeutic areas. The Senior Director , CMC Statistics, will manage, act as a technical expert for, and… more
- Lilly (Indianapolis, IN)
- …support communities through philanthropy and volunteerism. **Position Summary:** The Senior Director , CMC Project Management will provide strategic and ... operational leadership for cross-functional CMC team(s) and will partner with CMC ...cross-functional CMC team(s) and will partner with CMC scientific and technical leaders with accountability for technical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible ... portfolio. This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global… more
- UTMB Health (Gatesville, TX)
- Regional Medical Director , CMC **Gatesville, Texas, United States** Physician UTMB Health Requisition # 2500313 The mission of Correctional Managed Care is to ... Texas Juvenile Justice Department (TJJD). **_JOB SUMMARY_** **:** Serves as medical director for a number of correctional facilities within a designated region.… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Site CMC ensures efficient and compliant management of regulatory ... scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory … more
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of ... this position you will be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality CMC … more
- Bristol Myers Squibb (Indianapolis, IN)
- …leader in radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will ... to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility located in Indianapolis.… more
- AbbVie (North Chicago, IL)
- …high complexity utilizing a matrix approach. Leads Chemistry, Manufacturing and Controls ( CMC ) teams and Product Presentation and Device Strategy Teams (PPDST) of ... key member of AST, has accountability for creating a CMC strategy and development plan that aligns with overarching...a differentiated product. Serves as the spokesperson for all CMC functions and ensures information flow among AST and… more
- WuXi AppTec (Boston, MA)
- …of 5 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing. + Working knowledge and understanding of ... problems **Leadership Activities:** + Work closely with team members across all CMC -related business units and with the STA management team to ensure coordination… more
- Merck (Madison, WI)
- **Job Description** ** Director , Combination Product Regulatory CMC - (R5)** This Principal Scientist position is equivalent to a Director position. Under ... direction from the Combination Product Regulatory CMC Team Leader, the Principal Scientist is responsible for...Principal Scientist is responsible for executing in the Regulatory CMC space. Leveraging demonstrated capability in Regulatory CMC… more
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