Sr. Associate Scientist, Drug Substance-Data Science (Contract)

About the role

Allogene Therapeutics is a clinical-stage biotechnology company focusing on allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer and autoimmune diseases. Led by experienced professionals in cell therapy, Allogene aims to develop “off-the-shelf” CAR T cell products for more reliable and scalable cell therapy access.

Responsibilities

• Contributes to the development and implementation of Cell Starting Material characterization studies using Quality by Design (QbD) principles to support process understanding, optimization, and characterization activities.
• Applies advanced statistical tools to large and complex data sets to advance raw materials and product understanding.
• Serves as a key contributor to clinical-scale non-GMP manufacturing operations for executing BLA-enabling process characterization activities.
• Supports and contributes to process characterization efforts and continuous improvement initiatives aimed at enhancing CAR-T manufacturing processes and capabilities (evaluation of process parameters, materials, closed or disposable systems, and operational workflows).
• Participates in Project Technical Teams and communicates effectively with all stakeholders.
• Ensures high-quality, timely documentation in electronic laboratory notebooks and technical reports, contributing to regulatory filings and responses to regulatory questions as appropriate.
• Presents data and strategies to scientists and management in internal venues (technical meetings, Project Team meetings) as needed.
• Remains current with relevant cell therapy, immunology, and bioprocessing literature.

Position Requirements & Experience

• BS/MS in Molecular & Cell Biology, Immunology with emphasis on data science preferred. MS with at least 2 years of experience or BS with at least 5 years of experience.
• A demonstrated foundational understanding of mammalian or primary cell culture, biochemistry, molecular & cell biology, and immunology (required for enhanced product & process understanding).
• Experience in Quality by Design methodologies and statistical modeling in biologics or cell therapy space is highly preferred.
• Experienced with multivariate data analysis, preferred experience with statistical software (JMP, R-Studio, Python).
• Experience in designing and deploying dashboards for real-time process monitoring, improving data accessibility and decision-making capabilities.
• Experience in flow cytometry is highly preferred.
• Experience with prior Gene & Cell Therapy manufacturing preferred but not required.
• Experience in genetic modification of cells using gene editing and gene delivery technologies preferred but not required.
• Experience with PBMC isolation techniques preferred but not required.
• Ability to work in a fast-paced, startup environment.
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines.
• Ability to work independently and as part of a team.
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.

Benefits

We offer a competitive compensation and benefits package, including an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns), and much more. The expected salary range for this role is $45.00 to $50.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.