Job Summary:
Allogene Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic CAR T cell products for cancer and autoimmune diseases. They are seeking a highly motivated Data Science Engineer to support manufacturing processes through robust data management and analysis, ensuring compliance with GMP and regulatory standards.
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
• Other duties as assigned
Qualifications:
Required:
• 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.
• 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.
• 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%.
• Candidates must be authorized to work in the U.S.
Preferred:
• Late-stage clinical and commercial experience.
• Cell therapy experience.
• Experience developing and implementing data solutions with machine learning and AI.
Company:
Allogene Therapeutics is a biotechnology company catalyzing cancer treatment through the development of CAR T therapy. Founded in 2017, the company is headquartered in South San Francisco, USA, with a team of 201-500 employees. The company is currently Growth Stage.