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Associate Director, CMC Analytical Chemistry
1 month ago
Cytokinetics is a leading biopharmaceutical company focused on developing innovative treatments for cardiovascular diseases. We are seeking an experienced Associate Director to join our team in a key leadership role.
Job SummaryThe Associate Director will be responsible for leading our analytical development activities, providing technical expertise, and managing laboratory functions at contract manufacturing organizations (CMOs). This role will also involve mentoring and coaching junior team members, developing best practices, and streamlining operational procedures.
Key Responsibilities- Lead and track analytical development activities for supported pipeline products
- Provide analytical support for process chemistry and formulation development
- Manage and oversee all analytical laboratory functions at CMOs
- Conduct technical reviews of QC data generated at CMOs
- Develop and manage stage-appropriate stability programs
- Establish and justify specifications for drug substances and products
- Provide analytical expertise for deviations and OOS/OOT investigations
- Draft technical paragraphs for regulatory submissions
- Interface with other scientific disciplines
- Support operational budgets and resource planning
- Ph.D. in Analytical Chemistry or related discipline
- 8+ years of experience in pharmaceutical development industry
- Leadership and management experience in AD/QC
- Expert knowledge of chromatographic methods and instrumentation
- Excellent communication and decision-making skills
- Knowledge of cGMP compliance, ICH guidelines, and HA regulations
Cytokinetics is an equal opportunity employer and offers a competitive salary range of $182,000-$222,000 USD. We celebrate diversity and are looking for the best candidates to join our team.
