Associate Director, Quality Engineer (Data Science)

TL;DR

Associate Director, Quality Engineer (Data Science): Leading the Quality Data Science and Quality Engineering function to implement applied statistics and machine learning within an allogeneic CAR T platform with an accent on GMP operations and product quality control. Focus on developing data-driven strategies for process validation, product comparability, and continuous improvement to accelerate the development of off-the-shelf cell therapies.

Location: Must be based in or able to work hybrid in South San Francisco, CA. Candidates must be authorized to work in the U.S.

Salary: $170,000–$210,000 per year

Company

hirify.global is a clinical-stage biotechnology company pioneering the development of allogeneic CAR T cell products for cancer and autoimmune diseases.

What you will do

• Develop and execute a strategy to establish quality data science as a core capability for GMP operations.
• Apply statistical principles to drive process understanding, product comparability, and stability trending.
• Contribute to the build-out of the GMP Quality Management System and support regulatory submissions.
• Lead root cause investigations and promote data-driven decision-making across the enterprise.
• Collaborate with cross-functional teams to implement a Knowledge Management approach.
• Identify and implement industry best practices and new technologies for quality engineering.

Requirements

• BS/MS in Statistics, Data Science, or related field (advanced degree preferred).
• 6-8 years of relevant experience in the biotechnology or pharmaceutical industry.
• Expertise in applied statistics (DoE, multivariate analysis, regression, time-series).
• Hands-on experience with R, Python, JMP, or SAS.
• Must be authorized to work in the U.S.
• Comprehensive knowledge of GMP regulations and industry best practices.

Nice to have

• ASQ Quality Engineer certification.
• Experience with visualization tools.

Culture & Benefits

• Collaborative environment with talented professionals in the cell therapy space.
• Top-notch compensation package including annual performance bonus and equity.
• Comprehensive health insurance and generous time off.
• Two annual company-wide holiday shutdowns.