Senior Manager, CMC Analytics — Late-Stage & Commercial

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

Benefits offered by this job

Stock options

Restricted stock units

Health insurance

Dental coverage

Vision coverage

Life insurance

Disability insurance

401k with match

Wellness stipend

Paid time off

Job summary

Cytokinetics Incorporated in South San Francisco, CA, seeks a Senior Manager, CMC Analytical, to lead analytical development and quality control activities for late-stage programs and commercial manufacturing. You will serve as the primary analytical lead, directing method development, validation, transfer, and QC deliverables with internal teams and external partners.

This role requires GMP expertise, CRO/CDMO oversight, data integrity, and proactive risk management to support regulatory

Qualifications

• BS in analytical/organic chemistry or related field; advanced degrees preferred.
• 5+ years in analytical development and/or QC, with external partners.
• Experience managing CROs/CDMOs and GMP change controls.
• Regulatory submission experience (IND/IMPD/NDA) is a plus.

Responsibilities

• Lead analytical development and QC activities for late-stage programs and commercial manufacturing.
• Oversee CROs/CDMOs for method development, validation, transfer, and testing.
• Review data, protocols, reports, and GMP/regulatory documents for compliance.
• Support drug substance/product teams and regulatory submissions.
• Lead investigations and CAPAs related to analytical results.

Skills

Analytical development

Quality Control

GMP compliance

CRO/CDMO management

Regulatory submissions

Communication skills

Problem solving

Education

BS in analytical/organic chemistry

MS or PhD preferred

Job description

Cytokinetics Incorporated in South San Francisco, CA, seeks a Senior Manager, CMC Analytical, to lead analytical development and quality control activities for late-stage programs and commercial manufacturing. You will serve as the primary analytical lead, directing method development, validation, transfer, and QC deliverables with internal teams and external partners.

This role requires GMP expertise, CRO/CDMO oversight, data integrity, and proactive risk management to support regulatory