Senior Manager, CMC Analytical Chemistry
About The Position
Cytokinetics is a specialty cardiovascular biopharmaceutical company developing potential medicines for patients with diseases of impaired cardiac muscle function. The Senior Manager, CMC Analytical, executes and oversees analytical development and quality control activities supporting late-stage development and commercial manufacturing. This position serves as the primary analytical lead for assigned programs and is accountable for timely analytical method development, validation, transfer, and quality control activities through internal and external partners. The role manages contract laboratories and manufacturing partners to ensure high-quality, compliant analytical deliverables supporting product development, regulatory submissions, commercial supply, stability programs, and lifecycle management. It calls for strong technical expertise, operational excellence, and a quality-focused approach in a GMP environment. The position contributes to the development of novel therapeutics and supports the launch of a new commercial product in a collaborative, cross-functional environment.
Requirements
- Minimum bachelor's degree in analytical chemistry, organic chemistry, or a related discipline.
- At least 5 years of relevant industrial experience in analytical development and/or Quality Control.
- Demonstrated experience independently managing analytical development and quality control activities for small-molecule oral solid dosage form products through external laboratories and manufacturing partners.
- Strong experience with GMP change controls and OOS investigations.
- Experience managing projects at CROs/CDMOs.
- Working experience and knowledge of regulatory submissions such as IND, IMPD, and/or NDA.
- Effective written and verbal communication and interpersonal skills.
- Strong knowledge of current ICH and GMP guidelines, USP, EP, and related industry practices.
- Strong technical troubleshooting, problem-solving, and execution skills, including the ability to make timely, data-driven decisions.
- Excellent scientific and business communication skills, including verbal, written, and technical communication; strong collaboration and planning skills.
- Ability to think critically and creatively, work independently, and determine appropriate resources to resolve problems.
- Ability to multitask and thrive in a fast-paced, innovative environment.
Nice To Haves
- Advanced degree, such as an MS or PhD.
Responsibilities
- Serve as the analytical subject matter expert for analytical development and quality control activities supporting assigned programs.
- Manage 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 for scientific quality, data integrity, and compliance with GMP and regulatory requirements.
- Provide analytical support to drug substance, drug product, and manufacturing teams.
- Execute analytical activities supporting 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 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 and supplier audits and regulatory inspections by providing analytical documentation and technical responses.
- Ensure analytical activities comply with current GMP regulations, ICH guidelines, internal procedures, and industry best practices.
- Contribute to continuous improvement initiatives that enhance analytical operations, documentation quality, and compliance performance.
- Support quality audits and health authority inspections.
- Promote a collaborative, innovative, and results-oriented analytical development culture.
Benefits
- Equity in the form of stock options and/or restricted stock units.
- Comprehensive health insurance coverage.
- Dental insurance coverage.
- Vision insurance coverage.
- Life insurance coverage.
- Disability insurance coverage.
- 401(k) retirement benefits with employer match.
- Learning stipends.
- Wellness stipends.
- Paid time off.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
