- Monster (Louisville, CO)
- Eli Lilly and Company seeks a Director , CMC Pharmaceutics to work collaboratively to develop and deliver appropriate drug products for different phases of animal ... and human studies. Guide pre-formulation characterization and the design of formulations. Monitor the development of appropriate analytical testing methods for drug products. Manage the manufacture of drug products for toxicology studies, clinical trials, and… more
- Programmable Medicine Operatin (Redwood City, CA)
- …Author and review technical documents such as protocols, reports, risk assessments, and CMC sections of regulatory filings Ability to review master batch records and ... participation in the annual bonus program. At the Associate Director level, the salary range for this position is...is $160,000 - $185,000 annually. The range for a Director is $185,000 $243,000. We consider various factors when… more
- Monster (Irvine, CA)
- …the needs of the patient and customer and the business objectives of the CMC and Product Strategy teams. In addition, product development timing and scope need to ... support plans for CMC gate reviews and each clinical phase. Top 3-5...Project Manager will be accountable to the Program Manager Director for delivering on the strategy, plans and budget… 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
- 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...Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority assets throughout clinical development. Key… more
- Lilly (Boulder, CO)
- …life better for people around the world. Eli Lilly and Company seeks a Director , CMC Pharmaceutics to work collaboratively to develop and deliver appropriate ... drug products for different phases of animal and human studies. Guide pre-formulation characterization and the design of formulations. Monitor the development of appropriate analytical testing methods for drug products. Manage the manufacture of drug products… more
- Actalent (Boston, MA)
- Job Title: Director Regulatory CMC Job Description We are seeking a creative and agile regulatory professional eager to join a collaborative team as a ... Director /Sr. Director of Regulatory CMC based in Boston with a hybrid option. This role involves providing Regulatory CMC leadership for a dynamic… more
- Kelly Services (South San Francisco, CA)
- Kelly(R) Science & Clinical is seeking a Director of CMC Quality for a direct hire opportunity with a leading biopharmaceutical company in South San Francisco, ... Hybrid, onsite in South San Francisco, CA 3 days/week. **Position Title:** Director of CMC Quality **Position Type:** Direct hire **Salary:** $245,000-285,0000… more
- Boehringer Ingelheim (Athens, GA)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director , Scientific Expert CMC is responsible for providing new product ... and priorities in close collaboration with Quality, R&D and Operations/Manufacturing. The Director , Scientific Expert CMC provides subject matter expertise in… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim is currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located ... all DP-related activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior...of CMC development within EACD. The Associate Director /Senior Associate Director of EACD for drug… 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
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of ... beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has… more
- UTMB Health (Galveston, TX)
- Director of Operations, - CMC - Galveston County Jail **Galveston, Texas, United States** Business, Managerial & Finance UTMB Health Requisition # 2503778 The ... time of offer. Standard office environment at UTMB's main campus or other CMC location. Security clearance is required; pre-employment drug testing is also required.… more
- AbbVie (North Chicago, IL)
- …third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality that are ... efficient processes for preparation, review and approval of these CMC sections. Plays a critical role in ensuring that...sections. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory… more
- Danaher Corporation (Fargo, ND)
- …and improve human health. We are seeking a strategic and technically accomplished Director of Drug Product CMC to lead client-facing drug product development ... is critical in driving the design, development, and execution of robust CMC strategies for a diverse portfolio of clients, spanning early-phase to commercial-stage… more
- UTMB Health (Stafford, TX)
- …treatment algorithms and practices. Works under the general direction of the UTMB - CMC , CHS medical director , with extensive latitude for the exercise of ... Staff Psychiatrist, CHS- CMC - CASUAL **Stafford, Texas, United States** Physician UTMB Health Requisition # 2503005 The mission of Correctional Managed Care is to… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Pharma Product Group Director will be fully responsible for providing CMC leadership and ... key leader within the S&T PPG group and supports CMC Leads across PDS&T, independently driving CMC ...supports CMC Leads across PDS&T, independently driving CMC initiatives. + Independently lead complex and/or hybrid cross-functional… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics....the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD … more
- Gilead Sciences, Inc. (Foster City, CA)
- …with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with ICH ... knowledge, and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + Actively… more
