CMC Analytical Lead — Senior Manager, GMP Analytics

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

Job summary

Cytokinetics, a cardiovascular biopharmaceutical company, seeks a Senior Manager, CMC Analytical to lead analytical development and QC activities for late-stage programs and commercial manufacturing. You will manage CROs/CDMOs, drive method development, validation, and regulatory support within a GMP framework.

The role requires strong scientific and communication skills, cross-functional collaboration, and a focus on quality and compliance in a fast-paced environment.

Qualifications

• BS in analytical chemistry or related field required; MS/PhD preferred.
• 5+ years in analytical development and/or QC.
• Experience managing external labs and manufacturing partners.
• GMP change controls and OOS investigations experience.
• Regulatory submission experience (IND/IMPD/NDA).

Responsibilities

• Act as SME for analytical development and QC activities.
• Oversee CROs/CDMOs for method development, validation, transfer, and testing.
• Review data, protocols, reports for GMP compliance and data integrity.
• Provide analytical support to drug substance and drug product teams.
• Support regulatory submissions and lifecycle management.
• Prepare and approve analytical protocols, reports, specs, and CMC sections.

Skills

Analytical development

Quality control

GMP compliance

Project management

Technical troubleshooting

Regulatory submissions

Communication skills

Independent work

CRO/CDMO management

Education

BS in analytical chemistry or related

MS or PhD preferred

Job description

Cytokinetics, a cardiovascular biopharmaceutical company, seeks a Senior Manager, CMC Analytical to lead analytical development and QC activities for late-stage programs and commercial manufacturing. You will manage CROs/CDMOs, drive method development, validation, and regulatory support within a GMP framework.

The role requires strong scientific and communication skills, cross-functional collaboration, and a focus on quality and compliance in a fast-paced environment.