Associate Director, Data Science

Allogene Therapeutics•South San Francisco, CA

2d•Onsite

About The Position

Allogene Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic CAR T cell therapies for cancer and autoimmune diseases. The company is seeking a highly motivated Associate Director, Quality Data Science to join their team. This role will be responsible for developing and leading the Quality Data Science/Quality Engineering function, applying principles of statistics, data science, and machine learning to advance Allogene's allogeneic CAR T platform. The position is based in South San Francisco, CA, and reports to the head of Validation and Quality Engineering. The Associate Director will collaborate with project teams to create a quality data science roadmap, implement product quality control strategies, and drive innovation and continuous improvement.

Requirements

BS/MS degree in Statistics, Data Science, or related field (advanced degree preferred)
At least 6-8 years of relevant experience in the biotechnology or pharmaceutical industry.
Strong expertise in applied statistics (e.g., DoE, multivariate analysis, regression, time‑series).
Hands‑on experience with tools such as R, Python, JMP, SAS, or equivalent.
Experience working with complex data from laboratory, process, or manufacturing systems and ability to translate complex data insights into actionable business recommendations.
Familiarity with visualization tools.
Comprehensive knowledge of GMP regulations, guidance, and industry best practices.
Proven success influencing cross‑functional teams and senior stakeholders without direct authority.
Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
Candidates must be authorized to work in the U.S.

Nice To Haves

ASQ Quality Engineer certification preferred

Responsibilities

Develop and execute strategy and roadmap to establish quality data science as a core capability for building allogeneic platform knowledge and establish data analytics to enable predict and prevent capabilities across GMP operations.
Provide direction and input to project teams utilizing the principles of applied science and statistics to drive strategies for process and analytical understanding and overall product quality control, including approaches for product comparability, process validation, product monitoring, stability trending and lifecycle management/improvement.
Contribute to the build out of the Allogene GMP Quality Management System by developing procedures and providing significant input and support to Product Quality Review and Management Review tools and practices.
Serve as company authority on quality data science and QE activities in support of regulatory submissions and inspections, including assuring inspection readiness.
Support root cause investigations and ensure data-driven decision making.
Champion the use of data analytics and operational excellence tools to drive process improvement and innovation across the Allogene enterprise.
Integral member of cross-functional teams to garner interdisciplinary insights (e.g. technical, clinical) to further accelerate Allogene’s leading approach to the establishment of an “off-the-shelf” allogeneic CAR T platform.
Collaborate across functions and stakeholders to develop a Knowledge Management approach for Allogene.
Routinely scan external environment and engage in industry forums to proactively identify and implement best practices and new technologies.