Drive the manufacturing future of allogeneic NK cell therapy.
Artiva is seeking a Director, MSAT, CMC & Process Validation to lead end-to-end process validation as we advance toward Phase 3. 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. Join a nimble biotech. Lead critical work. Make a difference for patients.
As the Director, MSAT & CMC Process Validation, you will lead process validation strategy and execution for Artiva's allogeneic manufacturing processes. As a senior member of the MSAT (Manufacturing Science &
Technology) organization, you will own the end-to-end validation lifecycle for our 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.
Duties/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.
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.
In addition to a great culture, we offer:
• A beautiful facility
• An entrepreneurial, highly collaborative, and innovative environment
• Comprehensive benefits, including:
• 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.
If all this speaks to you, come join us on our journey!
