CMC Quality Control Senior Manager: Late-Stage Analytics

Regulatory Jobs; South San Francisco (CA); On-site; USD 182,000 - 212,000; Full time

Benefits offered by this job

Stock options

Health, dental, vision, life insurance

401k with employer match

Paid time off

Job summary

Cytokinetics is seeking a Senior Manager, CMC Quality Control to drive analytical development and quality control for late-stage programs and commercial manufacturing. You will lead analytical method development, validation, transfer, and testing through internal and external partners, ensuring data integrity and regulatory readiness.

You will manage CROs/CDMOs and collaborate across drug substance, drug product, and manufacturing teams, guiding investigations, stability programs, and regulatory

Qualifications

• BS degree in analytical chemistry or related disciplines; advanced degrees preferred.
• 5+ years of relevant industrial experience in analytical development and/or Quality Control.
• Experience independently managing analytical development and quality control activities for small molecule oral solid dosage forms through external laboratories and manufacturing partners.
• Strong experience in GMP change controls and OOS investigations.
• Experience managing projects at CROs/CDMOs.
• Working knowledge of regulatory submissions (IND, IMPD, and/or NDA).
• Excellent written and verbal communication skills and interpersonal skills.
• Strong knowledge of ICH GMP USP EP and related industry practices.
• Strong troubleshooting, problem-solving and execution skills with data-driven decisions.
• Ability to multi-task in a fast-paced environment.
• #LI-ONSITE

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 for scientific quality, data integrity, and GMP/regulatory compliance.
• Provide analytical support to drug substance, drug product, and manufacturing teams to address development and 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, investigations (OOS/OOT), ensuring timely resolution and CAPAs.
• Manage stability studies and reference standard qualification/requalification programs.
• Monitor timelines, identify risks, and drive issue resolution to maintain schedules.
• Support quality audits, supplier audits, and regulatory inspections with analytical documentation.
• Ensure activities comply with GMP, ICH, internal procedures and industry best practices.
• Contribute to continuous improvement of analytical operations and documentation quality.
• Support quality audits and health authority inspections.
• Foster a collaborative, innovative analytical development culture.

Skills

Analytical chemistry

GMP compliance

Data integrity

Project management

CRO management

Regulatory submissions

Communication skills

Troubleshooting

Education

BS in analytical chemistry

MS/PhD preferred

Job description

Cytokinetics is seeking a Senior Manager, CMC Quality Control to drive analytical development and quality control for late-stage programs and commercial manufacturing. You will lead analytical method development, validation, transfer, and testing through internal and external partners, ensuring data integrity and regulatory readiness.

You will manage CROs/CDMOs and collaborate across drug substance, drug product, and manufacturing teams, guiding investigations, stability programs, and regulatory