Director, Product Quality Leader (Biotech)

TL;DR

Director, Product Quality Leader (Biotech): Overseeing CAR T programs including starting materials and manufacturing quality with an accent on product design, characterization, and qualification. Focus on coordinating Quality activities for clinical and commercial use, ensuring regulatory compliance (FDA), and managing CMOs.

Location: Hybrid; must work out of the Newark, California office

Salary: $200,000 - $230,000 per year

Company

A biotechnology company focused on developing allogeneic cell therapies for patients.

What you will do

• Oversee CAR T programs, including cell starting materials, viral vectors, and nucleic acids.
• Coordinate Quality activities for drug substance and product manufacturing internally and at contract manufacturing organizations (CMO).
• Formulate product control strategies and design stability studies in alignment with development teams.
• Drive the development of product specifications, justifications, and bridging strategies for analytical methods.
• Manage discrepancies, Out Of Specifications (OOS) results, and CAPA implementation.
• Author and review technical registration documents and submissions for regulatory agencies (FDA).

Requirements

• Ph.D. degree in Life Sciences with 7-10 years of experience in biotechnology.
• Deep understanding of biological drug development from early stages to commercial launch.
• Solid knowledge of cGMP and regulatory compliance for US and international agencies.
• Experience with analytical/biological methods development, optimization, validation, and stability programs.
• Strong proficiency in statistics and experience with software such as JMP.
• Must be authorized to work in the U.S.

Culture & Benefits

• Collaborative work environment with talented peers.
• Competitive compensation including annual performance bonus and equity.
• Comprehensive health insurance and generous time off, including two annual company-wide shutdowns.
• Hybrid work model.