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Artiva Biotherapeutics, a clinical-stage biotech company developing allogeneic NK cell therapies, seeks a Director of Process Validation & Manufacturing Science to lead end-to-end process validation as the company advances toward Phase 3 clinical trials.
In this role, you will own the complete process validation lifecycle for Artiva's manufacturing operations—from process characterization and design (Stage 1) through PPQ (Stage 2) and continued process verification (Stage 3)—ensuring alignment with FDA, EMA, and ICH regulatory expectations. You will serve as a key technical leader at the intersection of MSAT (Manufacturing Science & Technology), CMC (Chemistry, Manufacturing, and Controls), and GMP manufacturing operations.
Key responsibilities include:
• Developing and executing process validation strategy and lifecycle management, including protocol authoring, hands-on PPQ campaign leadership, and real-time manufacturing floor support.
• Defining control strategies, process monitoring plans, and CPV trending programs; driving data-driven decisions on process capability and performance.
• Managing process data integrity, structured data capture, and validation dataset governance; building dashboards for real-time visibility into process performance and validation status.
• Supporting day-to-day manufacturing through master batch record review, deviation authoring, investigation support, and CAPA development with verified effectiveness checks.
• Authoring CMC sections of regulatory filings (IND, BLA, MAA) and serving as the validation subject matter expert during regulatory inspections and health authority interactions.
• Cross-functional partnership with QA, QC, Product Development, Manufacturing, Supply Chain, and Regulatory Affairs to ensure timely information flow and alignment on critical milestones.
• Building, mentoring, and developing validation and MSAT talent as the organization scales toward commercial readiness.
• Championing continuous improvement initiatives and establishing validation lifecycle standards and best practices.
You will report to leadership and play a critical role in de-risking the manufacturing process for a potentially transformative cell therapy platform.
