Director, MSAT, CMC and Process Validation

Artiva Biotherapeutics • San Diego, CA

1d • $195,000 - $220,000

About The Position

Artiva is seeking a Director, MSAT, CMC & Process Validation to lead end-to-end process validation as we advance toward Phase 3. This role will own the journey from process characterization through PPQ and continued process verification, partnering across MSAT, CMC, Quality, and GMP Manufacturing. Late-stage development experience and hands-on PPQ execution are must-haves. The Director will lead process validation strategy and execution for Artiva's allogeneic manufacturing processes. As a senior member of the MSAT (Manufacturing Science & Technology) organization, this role will own the end-to-end validation lifecycle for Artiva's biopharmaceutical plant — from process characterization through PPQ and continued process verification — and serve as a key technical leader at the intersection of MSAT, CMC, and GMP manufacturing operations.

Requirements

• Bachelor's, Master's, or PhD in biotechnology, chemical engineering, or related discipline.
• Minimum 5 years of experience in process validation, MSAT, and/or manufacturing within a cGMPregulated biopharmaceutical environment, including leadership of technical teams and complex crossfunctional programs.
• Late-stage development experience with hands-on PPQ execution is a must — candidates must have directly led or executed PPQ campaigns, not solely in an oversight capacity.
• Strong working knowledge of CMC and GMP operations, including quality systems (change control, deviations, CAPA), batch disposition, and regulatory filing strategy.
• Strong technology transfer experience required; cell therapy or other complex biologics experience strongly preferred.
• Deep understanding of ICH, FDA, and EMA guidelines, including the FDA process validation lifecycle framework and process capability expectations.
• Excellent technical writing skills, with demonstrated authorship of validation documents and CMC regulatory sections.
• Excellent communication, stakeholder management, and executive presence; able to represent validation strategy to senior leadership and health authorities.

Nice To Haves

• cell therapy or other complex biologics experience strongly preferred.

Responsibilities

• Own the process validation strategy and lifecycle for Artiva's manufacturing processes — Stage 1 (process design/characterization) through Stage 2 (PPQ) and Stage 3 (Continued Process Verification) — in alignment with FDA, EMA, and ICH expectations.
• Lead the planning, authoring, execution, and disposition of process validation protocols and reports, including studies demonstrating the suitability and robustness of manufacturing processes.
• Provide hands-on technical leadership for PPQ campaigns, including protocol design, acceptance criteria, real-time execution support on the manufacturing floor, deviation triage, and report closure.
• Define and maintain control strategy elements, process monitoring plans, and CPV trending programs; drive data-driven decisions on process capability (Cpk/Ppk) and process performance.
• Support day-to-day manufacturing operations through master batch record (MBR) review and revision, authoring of deviations and investigations, and development of effective, sustainable CAPAs with verified effectiveness checks.
• Own process data management for validation and CPV, including data integrity, structured data capture from manufacturing runs, and governance of validation datasets.
• Build and maintain dashboards and data tracking tools for real-time visibility into process performance, CQA/CPP trending, and validation program status; establish statistical trending and alert/action limits to enable proactive process monitoring.
• Direct the management of technical risks associated with process validation, ensuring project completion in alignment with program milestones and regulatory filing timelines.
• Author and own CMC sections of regulatory filings (IND, BLA, MAA) and the technical content of validation reports; serve as validation SME during regulatory inspections and health authority interactions.
• Partner cross-functionally with QA, QC, PD, Manufacturing, Supply Chain, and Regulatory Affairs to ensure critical process and technical information flows to the right stakeholders on the required timelines.
• Ensure timely, rigorous assessment of change requests and validation-related deviations within the GMP quality system; drive disposition-enabling technical assessments.
• Build, mentor, and develop validation and MSAT talent; establish validation lifecycle strategies, standards, and best practices as the organization scales toward commercial readiness.
• Champion continuous improvement initiatives across MSAT, and manufacturing operations.
• Generously share information and knowledge across teams and functions. Demonstrate high integrity.

Benefits

• 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, including the year-end holiday week
• Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.

What This Job Offers

• Job Type: Full-time
• Career Level: Director