Senior Manager, CMC Analytical Chemistry
About The Position
Cytokinetics is a specialty cardiovascular biopharmaceutical company developing potential medicines for people with cardiovascular diseases involving impaired muscle function. The Senior Manager, CMC Analytical, executes and oversees analytical development and quality control activities supporting late-stage development and commercial manufacturing. As the primary analytical lead for assigned programs, this role is accountable for analytical method development, validation, transfer, and quality control activities conducted through internal teams and external partners. The position manages contract laboratories and manufacturing partners to deliver high-quality, compliant analytical work supporting product development, regulatory submissions, commercial supply, stability programs, and lifecycle management. It requires strong technical expertise, operational excellence, and a quality-focused approach in a GMP environment. The role offers the opportunity to contribute to novel therapeutics, support the launch of a new commercial product, and work in a collaborative, cross-functional team.
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 knowledge and experience with regulatory submissions such as IND, IMPD, and/or NDA.
- Strong knowledge of current ICH and GMP guidelines, USP, EP, and related industry practices.
- Effective written and verbal communication and interpersonal skills.
- Strong technical troubleshooting, problem-solving, and execution skills, including the ability to make timely, data-driven decisions.
- Strong scientific and business communication, 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 analytical method development, validation, transfer, troubleshooting, and testing.
- Review analytical data, protocols, reports, and technical documents for scientific quality, data integrity, and GMP and regulatory compliance.
- 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 work complies with current GMP regulations, ICH guidelines, internal procedures, and industry best practices.
- Contribute to continuous improvement in 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, dental, vision, life, and disability insurance coverage.
- 401(k) retirement benefits with employer match.
- Learning and wellness stipends.
- Paid time off.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
