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Associate Director, CMC Analytical Chemistry
1 month ago
Cytokinetics is a pioneering biopharmaceutical company dedicated to advancing muscle biology and mechanics. As a leader in the field, we are seeking an experienced Associate Director to join our CMC Analytical Chemistry team.
Key Responsibilities- Lead and track Analytical Development activities for pipeline products
- Provide analytical support for Process Chemistry and Formulation Development
- Manage and oversee all analytical laboratory functions at CMOs
- Conduct analytical technical review of QC data generated at CMOs
- Develop strategies and methodologies for analytical method validation, stability studies, and batch release testing
- Manage the transfer and/or validation of analytical methods to CMOs and independent contract testing laboratories
- Lead the development and management of stage-appropriate stability programs
- Establish and justify all specifications for drug substances and drug products
- Provide analytical expertise for deviations and OOS/OOT investigations
- Draft technical paragraphs for IND/IMPD/CTD supporting global CMC regulatory submissions
- Ph.D. in Analytical Chemistry or related discipline with 8+ years of pharmaceutical development industry experience in AD and QC
- Demonstrated record of excellence in leadership and management of AD/QC in a small molecule drug development industry environment
- Expert knowledge and hands-on experience with chromatographic methods and modern analytical instrumentation
- Highly organized and self-motivated with excellent interpersonal communication and decision-making skills
- Expert knowledge of cGMP compliance, ICH guidelines, compendial standards, and HA regulations pertaining to pharmaceutical manufacturing, method validations, product specifications, stability programs, and other QC/AD activities
Cytokinetics is an Equal Opportunity Employer. We offer a competitive salary range of $182,000-$222,000 USD and a dynamic work environment that values integrity, ethics, and critical thinking. If you are passionate about advancing muscle biology and mechanics, we encourage you to apply.
