Director, MSAT, CMC and Process Validation

artivabio; San Diego (CA); On-site; USD 180,000 - 300,000; 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)

Year-end holidays

Job summary

Artiva is seeking a Director, MSAT, CMC & Process Validation to lead end-to-end validation for allogeneic NK cell manufacturing. You will drive process characterization through PPQ and continued process verification, partnering with MSAT, CMC, Quality, and GMP Manufacturing.

Late-stage development and hands-on PPQ execution are essential. As a senior MSAT leader, you will own CMC sections of IND/ BLA filings, build validation datasets, and mentor teams while aligning with FDA/EMA guidelines and

Qualifications

• Experience leading validation programs in a cGMP biopharma setting.
• Strong track record in PPQ campaigns and regulatory filings.
• Proven ability to manage cross-functional teams and communicate with health authorities.

Responsibilities

• Own end-to-end process validation lifecycle from design to PPQ and CPV.
• Lead PPQ campaigns, including protocol design, criteria, and report closure.
• Develop control strategies, monitoring plans, and CPV trending programs.
• Coordinate with QA, QC, PD, Manufacturing, Regulatory Affairs on timelines.

Skills

Leadership

Regulatory strategy

Technical writing

Cross-functional leadership

Education

Bachelor's/Master's/PhD in biotech or chemical engineering

Tools

cGMP systems

Statistical analysis

Job description

About Artiva:

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK® , is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, create an opportunity to generate potentially transformative therapies.

Lead. Validate. Transform Cell Therapies.

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.

For more information, visit www.artivabio.com.

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.