Director, Attribute Sciences (Biotech)

TL;DR

Director, Attribute Sciences (Biotech): Leading product characterization strategy for AlloCAR T products in support of BLA filing with an accent on regulatory alignment and process-to-product understanding. Focus on developing analytical strategies for gene editing technologies and coordinating with cross-functional teams to ensure successful regulatory submissions.

Location: Onsite in South San Francisco, CA. Candidates must be authorized to work in the U.S.

Salary: $200,000–$230,000 per year

Company

A clinical-stage biotechnology company pioneering allogeneic CAR T cell products for cancer and autoimmune diseases.

What you will do

• Develop and author product characterization strategies for regulatory filings from IND to BLA.
• Lead innovation programs to enhance CAR T cell characterization and process-to-product understanding.
• Collaborate with Process Science leads to identify and evaluate Critical Quality Attributes (CQAs).
• Analyze the impact of gene editing (TALEN, CRISPR) and gene insertion technologies on cell therapy products.
• Mentor junior colleagues and uphold safe, high-quality laboratory practices.
• Ensure timely and high-quality documentation in electronic laboratory notebooks and Technical Reports.

Requirements

• PhD, MS, or BS in Immunology, cell and molecular biology, or equivalent.
• At least 10 years of relevant experience in the development of cell therapy analytical methods.
• Proven ability to lead teams in elucidating complex cell therapy product understanding.
• Strong technical and strategic leadership and problem-solving skills.
• Excellent verbal and written communication skills.
• Must be authorized to work in the U.S.

Nice to have

• Direct experience contributing to BLA authorship and understanding of ICH/global regulatory agency guidance.
• Prior industry experience in cell therapy analytical development and characterization.

Culture & Benefits

• Collaborative environment working with top-tier scientific talent.
• Comprehensive compensation package including an annual performance bonus and equity.
• Full health insurance coverage.
• Generous time off, including two annual company-wide holiday shutdowns.