MSAT Data Science Engineer

About the role

Allogene Therapeutics is a clinical-stage biotechnology company focusing on allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. The company's Manufacturing organization is building a world-class team to deliver potentially lifesaving therapies to patients.

Responsibilities

• Ownership of data lake infrastructure, including data ingestion, cleaning, organization, visualization and integration with data analysis tools.
• Translate process understanding into data and develop data analysis methodology to inform process and quality decisions.
• Generate data packages to support PPQ-readiness, PPQ execution and BLA submission for allogeneic CAR-T therapies and critical starting materials.
• Able to apply and develop advanced technologies, scientific principles, theories and concepts to meet the needs of the Process Development and Manufacturing teams, including support of technology transfers.
• In-depth knowledge of GMP and regulatory expectations and experience with regulatory inspections.
• Work with Quality, Facilities & Engineering, Process Development and IT to ensure cross-functional alignment.
• Closely partner with the Process Development and Quality groups to ensure continuity of data, robust process design and monitoring of product quality.
• Contribute to company-wide AI initiatives as a thought leader for introduction and implementation of new AI tools for continuous improvement and innovation.
• Engage with broader manufacturing team to enable accomplishment of department goals.

Position Requirements & Experience

• Bachelor’s degree in science or engineering (with a focus on computer science or data science preferred) with a minimum of 6 years of experience within a GMP pharmaceutical manufacturing space and 2 years of direct data science experience within a GMP pharmaceutical manufacturing space.
• Late-stage clinical and commercial experience preferred.
• Proficiency in programming languages including SQL, Python and R and data analytics tools, including JMP, Spotfire, Tableau, R-Studio.
• Knowledge of pharmaceutical manufacturing processes and GMP requirements for data integrity. Cell therapy experience preferred.
• Experience developing and implementing data solutions with machine learning and AI preferred.
• Excellent written and verbal communication skills.
• 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.
• Ability to travel up to 10%.

Benefits

The expected salary range for this role is $120,000 to $140,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.