Director, MSAT, CMC and Process Validation
Artiva Biotherapeutics
August 20, 2026
On-site
San Diego, CA
Operations
Responsibilities:
- Own the process validation strategy and lifecycle (Stage 1 process design/characterization, Stage 2 PPQ, Stage 3 Continued Process Verification) in line with FDA, EMA, and ICH expectations.
- Plan, author, execute, and disposition process validation protocols and reports demonstrating suitability and robustness of manufacturing processes.
- Provide hands-on PPQ technical leadership (protocol design, acceptance criteria, real-time manufacturing floor execution support, deviation triage, report closure).
- Define/maintain control strategy elements, process monitoring plans, and CPV trending; drive data-driven decisions on process capability (Cpk/Ppk) and performance.
- Support manufacturing operations via MBR review/revision, deviations/investigations, and sustainable CAPAs with verified effectiveness.
- Own process data management for validation/CPV, including data integrity, structured data capture, and governance of validation datasets.
- Build dashboards/tracking tools for real-time visibility into process performance, CQA/CPP trending, and validation status; establish statistical trending and alert/action limits.
- Manage technical risks for validation deliverables to meet milestones and regulatory filing timelines.
- Author/own CMC sections of IND/BLA/MAA and validation report technical content; serve as validation SME for inspections and health authority interactions.
- Partner cross-functionally with QA, QC, PD, Manufacturing, Supply Chain, and Regulatory Affairs.
- Assess change requests and validation-related deviations; drive disposition-enabling technical assessments.
- Build/mentor validation and MSAT talent; champion continuous improvement.
Requirements:
- BS/MS/PhD in biotechnology, chemical engineering, or related.
- 5+ years in process validation/MSAT and/or cGMP biopharma manufacturing with technical leadership and complex cross-functional programs.
- Late-stage experience with hands-on PPQ execution (directly led or executed PPQ campaigns).
- Strong CMC/GMP knowledge (quality systems, change control, deviations, CAPA, batch disposition, regulatory filing strategy).
- Strong technology transfer; cell therapy/complex biologics preferred.
- Deep ICH/FDA/EMA knowledge and FDA process validation lifecycle framework.
- Excellent technical writing and proven authorship of validation documents/CMC regulatory sections.
- Strong communication/stakeholder management and executive/health authority presence.
Benefits:
- Medical, Dental, and Vision; Group Life Insurance; Long-Term Disability (LTD); 401(k); EAP; FSA; PTO; company-paid holidays; Bonus.ly recognition program.
- Own the process validation strategy and lifecycle (Stage 1 process design/characterization, Stage 2 PPQ, Stage 3 Continued Process Verification) in line with FDA, EMA, and ICH expectations.
- Plan, author, execute, and disposition process validation protocols and reports demonstrating suitability and robustness of manufacturing processes.
- Provide hands-on PPQ technical leadership (protocol design, acceptance criteria, real-time manufacturing floor execution support, deviation triage, report closure).
- Define/maintain control strategy elements, process monitoring plans, and CPV trending; drive data-driven decisions on process capability (Cpk/Ppk) and performance.
- Support manufacturing operations via MBR review/revision, deviations/investigations, and sustainable CAPAs with verified effectiveness.
- Own process data management for validation/CPV, including data integrity, structured data capture, and governance of validation datasets.
- Build dashboards/tracking tools for real-time visibility into process performance, CQA/CPP trending, and validation status; establish statistical trending and alert/action limits.
- Manage technical risks for validation deliverables to meet milestones and regulatory filing timelines.
- Author/own CMC sections of IND/BLA/MAA and validation report technical content; serve as validation SME for inspections and health authority interactions.
- Partner cross-functionally with QA, QC, PD, Manufacturing, Supply Chain, and Regulatory Affairs.
- Assess change requests and validation-related deviations; drive disposition-enabling technical assessments.
- Build/mentor validation and MSAT talent; champion continuous improvement.
Requirements:
- BS/MS/PhD in biotechnology, chemical engineering, or related.
- 5+ years in process validation/MSAT and/or cGMP biopharma manufacturing with technical leadership and complex cross-functional programs.
- Late-stage experience with hands-on PPQ execution (directly led or executed PPQ campaigns).
- Strong CMC/GMP knowledge (quality systems, change control, deviations, CAPA, batch disposition, regulatory filing strategy).
- Strong technology transfer; cell therapy/complex biologics preferred.
- Deep ICH/FDA/EMA knowledge and FDA process validation lifecycle framework.
- Excellent technical writing and proven authorship of validation documents/CMC regulatory sections.
- Strong communication/stakeholder management and executive/health authority presence.
Benefits:
- Medical, Dental, and Vision; Group Life Insurance; Long-Term Disability (LTD); 401(k); EAP; FSA; PTO; company-paid holidays; Bonus.ly recognition program.