Director, MSAT & CMC Process Validation — PPQ Leader

Artiva Biotherapeutics; San Diego (CA); On-site; USD 210,000 - 270,000; 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)

Company-paid holidays

Bonus.ly recognition program

Job summary

Artiva Biotherapeutics in San Diego, CA seeks a Director, MSAT, CMC & Process Validation to lead end-to-end process validation for allogeneic manufacturing. You will own the validation lifecycle from process characterization through PPQ and continued process verification, collaborating across MSAT, CMC, Quality, and GMP Manufacturing.

The role requires hands-on PPQ execution in late-stage development, deep CMC/GMP knowledge, and leadership of cross-functional teams.

Qualifications

• 5+ years in process validation, MSAT, and/or biopharma manufacturing.
• Experience leading technical teams and cross-functional programs.
• Hands-on PPQ experience in late-stage development required.
• Strong knowledge of CMC, GMP, change control, deviations, and CAPA.

Responsibilities

• Own the validation strategy and lifecycle from design/characterization through PPQ and CPV.
• Lead PPQ campaigns with protocol design, acceptance criteria, and on-floor support.
• Define control strategy elements and monitoring plans; drive data-driven decisions.
• Author CMC sections of regulatory filings and validation reports; support inspections.
• Mentor MSAT talent and promote best practices across GMP operations.

Skills

Leadership

PPQ Execution

CMC/GMP Knowledge

Regulatory Liaison

Cross-functional Collaboration

Education

Bachelor/Master/PhD in biotech or chemical engineering

Job description

Artiva Biotherapeutics in San Diego, CA seeks a Director, MSAT, CMC & Process Validation to lead end-to-end process validation for allogeneic manufacturing. You will own the validation lifecycle from process characterization through PPQ and continued process verification, collaborating across MSAT, CMC, Quality, and GMP Manufacturing.

The role requires hands-on PPQ execution in late-stage development, deep CMC/GMP knowledge, and leadership of cross-functional teams.