Explore high-impact Associate Director, CMC Operations jobs, a pivotal senior leadership role at the heart of pharmaceutical and biotechnology product development. Professionals in this career path serve as the critical operational engine for Chemistry, Manufacturing, and Controls (CMC), ensuring that drug substances and products are developed, manufactured, and controlled consistently to the highest standards of quality, efficacy, and safety. This position is essential for bridging scientific development with commercial scalability, making it a cornerstone for bringing new therapies from the lab to patients. An Associate Director of CMC Operations typically oversees the execution and management of all CMC-related activities across one or more drug development programs. Common responsibilities include leading cross-functional CMC sub-teams, managing relationships with Contract Development and Manufacturing Organizations (CDMOs), and overseeing technology transfers between development and manufacturing sites. They are accountable for the seamless planning and execution of manufacturing campaigns for clinical trial materials and, eventually, commercial supply. A significant part of the role involves contributing to or authoring critical CMC sections for regulatory submissions (e.g., IND, IMPD, BLA, NDA) and interacting with Quality and Regulatory Affairs to ensure compliance. Furthermore, these professionals often hold budgetary responsibility for CMC functions, requiring diligent financial forecasting, monitoring, and resource allocation to ensure projects remain on time and within budget. The typical profile for candidates seeking Associate Director, CMC Operations jobs includes an advanced degree (Bachelor’s required, Master’s or Ph.D. often preferred) in Chemistry, Chemical Engineering, Pharmacy, or a related life science discipline. A minimum of 8-12 years of progressive experience within pharmaceutical CMC development, tech transfer, or manufacturing is standard. Successful individuals possess a robust blend of technical expertise and strategic project management skills. They must demonstrate excellent communication and leadership abilities to collaborate effectively with internal stakeholders and external partners. Proficiency in problem-solving, risk management, and navigating complex, ambiguous situations is paramount. Familiarity with current Good Manufacturing Practices (cGMP) and regulatory guidelines is essential. For those aiming to advance their career in biopharma operations, these jobs offer a unique opportunity to drive tangible results that directly impact a company’s pipeline and market success. Discover your next leadership challenge in this dynamic field where scientific rigor meets operational excellence.
