Director, MSAT & CMC — Process Validation Leader

artivabio; San Diego (CA); On-site; USD 180,000 - 300,000; Full time

Benefits offered by this job

Medical, Dental, and Vision

Group Life Insurance

Long-Term Disability

401(k) Retirement Plan

Employee Assistance Program (EAP)

Flexible Spending Account (FSA)

Paid Time Off (PTO)

Year-end holidays

Job summary

Artiva is seeking a Director, MSAT, CMC & Process Validation to lead end-to-end validation for allogeneic NK cell manufacturing. You will drive process characterization through PPQ and continued process verification, partnering with MSAT, CMC, Quality, and GMP Manufacturing.

Late-stage development and hands-on PPQ execution are essential. As a senior MSAT leader, you will own CMC sections of IND/ BLA filings, build validation datasets, and mentor teams while aligning with FDA/EMA guidelines and

Qualifications

• Experience leading validation programs in a cGMP biopharma setting.
• Strong track record in PPQ campaigns and regulatory filings.
• Proven ability to manage cross-functional teams and communicate with health authorities.

Responsibilities

• Own end-to-end process validation lifecycle from design to PPQ and CPV.
• Lead PPQ campaigns, including protocol design, criteria, and report closure.
• Develop control strategies, monitoring plans, and CPV trending programs.
• Coordinate with QA, QC, PD, Manufacturing, Regulatory Affairs on timelines.

Skills

Leadership

Regulatory strategy

Technical writing

Cross-functional leadership

Education

Bachelor's/Master's/PhD in biotech or chemical engineering

Tools

cGMP systems

Statistical analysis

Job description

Artiva is seeking a Director, MSAT, CMC & Process Validation to lead end-to-end validation for allogeneic NK cell manufacturing. You will drive process characterization through PPQ and continued process verification, partnering with MSAT, CMC, Quality, and GMP Manufacturing.

Late-stage development and hands-on PPQ execution are essential. As a senior MSAT leader, you will own CMC sections of IND/ BLA filings, build validation datasets, and mentor teams while aligning with FDA/EMA guidelines and