CMC Analytical Lead – Senior Manager, Late-Stage GMP

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

Benefits offered by this job

Stock options

Health insurance (medical, dental, etc

401k with employer match

Learning and wellness stipends

Job summary

Cytokinetics is seeking a Senior Manager, CMC Analytical, to lead analytical development and quality control activities for late-stage and commercial programs. You will oversee CROs/CDMOs, ensure data integrity, and support regulatory submissions in a GMP environment.

The role requires strong technical expertise, collaboration across cross-functional teams, and a focus on timely, compliant analytical deliverables.

Qualifications

• BS in analytical/organic chemistry or related field; MS/PhD preferred.
• 5+ years in analytical development and/or Quality Control in pharma.
• Experience leading analytical development for late-stage/ commercial products.

Responsibilities

• Lead analytical development, transfer, and validation activities for late-stage and commercial programs.
• Manage CROs/CDMOs to ensure timely, compliant analytical deliverables.
• Support regulatory submissions and lifecycle management with analytical data.

Skills

Analytical development

Quality Control

GMP

Regulatory submissions

Project management

Data analysis

Troubleshooting

Education

BS in analytical chemistry

MS/PhD preferred

Tools

HPLC

LC-MS

Analytical method validation

Job description

Cytokinetics is seeking a Senior Manager, CMC Analytical, to lead analytical development and quality control activities for late-stage and commercial programs. You will oversee CROs/CDMOs, ensure data integrity, and support regulatory submissions in a GMP environment.

The role requires strong technical expertise, collaboration across cross-functional teams, and a focus on timely, compliant analytical deliverables.