Director, MSAT & CMC Process Validation - Lead PPQ & CPV

Artiva Biotherapeutics Inc.; San Diego (CA); On-site; USD 180,000 - 250,000; Full time

Benefits offered by this job

Medical, Dental, and Vision

Group Life Insurance

Long-Term Disability (LTD)

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 Inc. in San Diego seeks a Director, MSAT, CMC & Process Validation to lead end-to-end process validation for allogeneic manufacturing, from process characterization through PPQ and continued process verification.

You will own validation strategy, author CMC sections of regulatory filings, mentor teams, coordinate across MSAT, CMC, QA, and manufacturing, and ensure readiness for Phase 3 and regulatory milestones.

Qualifications

• Experience leading validation programs from stage design through PPQ and CPV.
• Strong understanding of CMC, GMP, and quality systems (CAPA, change control).
• Proven ability to author regulatory content and interact with health authorities.

Responsibilities

• Lead end-to-end process validation strategy for Artiva’s manufacturing.
• Own PPQ campaigns including protocol design, acceptance criteria, and disposition.
• Direct validation data management, CPV trending, and regulatory filing content.

Skills

Process validation leadership

MSAT experience

PPQ execution

CMC & GMP operations

Regulatory filings (IND/BLA/MAA)

Technical writing

Cross-functional leadership

Statistical data analysis

Education

Bachelor’s, Master’s, or PhD in biotechnology, chemical engineering, or related discipline

Job description

Artiva Biotherapeutics Inc. in San Diego seeks a Director, MSAT, CMC & Process Validation to lead end-to-end process validation for allogeneic manufacturing, from process characterization through PPQ and continued process verification.

You will own validation strategy, author CMC sections of regulatory filings, mentor teams, coordinate across MSAT, CMC, QA, and manufacturing, and ensure readiness for Phase 3 and regulatory milestones.