Director, MSAT, CMC and Process Validation

Job overview

The Director, MSAT, CMC and Process Validation role is onsite in San Diego, CA. Compensation is not specified in the listing. Artiva Biotherapeutics develops natural killer cell-based therapies, including treatments being developed for autoimmune diseases. The director leads process validation strategy and execution across the validation lifecycle, from process characterization through process performance qualification and continued process verification. The role provides technical leadership for manufacturing readiness, regulatory documentation, quality-system work, and cross-functional coordination as Artiva advances its cell therapy programs toward later-stage development.

What you'll do

• Own process validation strategy and lifecycle
• plan, author, execute, and close validation protocols and reports
• lead hands-on PPQ campaigns
• define control strategies and process monitoring
• support manufacturing through batch record review, deviations, investigations, and CAPAs
• manage validation and CPV data
• author CMC regulatory filing sections
• partner with quality, manufacturing, regulatory, and other functions
• mentor validation and MSAT staff.

What we're looking for

Skills & competencies

director

msat

cmc

process validation

ppq

cell therapy

biopharmaceutical manufacturing

gmp

regulatory filings

san diego ca

artiva biotherapeutics

late-stage development

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, and vision
• group life insurance
• long-term disability
• 401(k)
• employee assistance program
• flexible spending account
• paid time off
• company-paid holidays
• recognition program.

Why this role

Leads end-to-end validation for allogeneic natural killer cell therapy manufacturing, including hands-on PPQ execution.

About the employer

Artiva Biotherapeutics is hiring for this role. Industry: Custom Computer Programming Services. Sector: 54.