Senior Manager, CMC Quality Control at Cytokinetics in San Francisco, CA

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. We welcome exceptional individuals to join us in our mission to develop potential medicines to improve the health span of people with cardiovascular diseases of impaired muscle function. We are seeking a highly skilled and motivated Analytical Chemist with expertise in late-stage analytical development and commercial manufacturing support. The ideal candidate is an experienced analytical professional with proven track records in Analytical Development, Quality Control, and technical support to Drug Substance and Drug Product manufacturing processes. This position offers an exciting opportunity to contribute to the development of novel therapeutics, support the launch of a new commercial product, and to work in a dynamic and collaborative cross functional team environment. Job Purpose The Senior Manager, CMC Quality Control, is responsible for the execution and oversight of analytical development and quality control activities supporting late-stage development and commercial manufacturing. This role serves as the primary analytical lead for assigned programs and is accountable for the timely execution of analytical method development, validation, transfer, and quality control activities through internal and external partners. The incumbent will manage contract laboratories and manufacturing partners to ensure high-quality, compliant analytical deliverables that support product development, regulatory submissions, commercial supply, stability programs, and lifecycle management. This role requires strong technical expertise, operational excellence, and a quality-focused mindset to ensure successful execution of analytical and quality control activities in a GMP environment. Responsibilities Serve as the analytical subject matter expert (SME) for analytical development and quality control activities supporting assigned programs. Manage and oversee CROs, contract testing laboratories, and CDMOs to ensure timely execution of analytical method development, validation, transfer, troubleshooting, and testing activities. Review analytical data, protocols, reports, and technical documents to ensure scientific quality, data integrity, and compliance with GMP and regulatory requirements. Provide analytical support to drug substance, drug product, and manufacturing teams to address development and commercial manufacturing needs. Execute analytical activities required to support regulatory submissions, post-approval changes, and lifecycle management. Prepare, review, and approve analytical protocols, reports, specifications, validation documents, and CMC sections of regulatory filings. Lead analytical change controls, deviations, laboratory investigations, and OOS/OOT investigations, ensuring timely resolution and implementation of effective CAPAs. Manage stability studies and reference standard qualification and requalification programs. Monitor analytical project timelines, identify risks, and drive issue resolution to maintain project and manufacturing schedules. Support quality audits, supplier audits, and regulatory inspections by providing analytical documentation and technical responses. Ensure analytical activities are conducted in compliance with current GMP regulations, ICH guidelines, internal procedures, and industry best practices. Contribute to continuous improvement initiatives to enhance analytical operations, documentation quality, and compliance performance. Support quality audit and health authority inspections. Strive for a collaborative, innovative, and results-oriented analytical development culture. Qualifications Minimum BS degree in analytical chemistry, organic chemistry or related disciplines. Advanced degrees (e.g. MS, PhD) are preferred. 5+ y