MSAT Data Science Engineer

Allogene Therapeutics•Newark, NJ

3d•Onsite

About The Position

Allogene's Manufacturing organization is building a world class team that is focused on delivering potentially lifesaving therapies to patients. We are seeking a highly motivated individual to join us as a Data Science Engineer, Manufacturing Sciences and Technology. This role will have hands-on responsibility over all manufacturing process data, including ensuring robust data infrastructure, data collection and analysis, and establishing best data management practices. This role will directly support technical and strategic initiatives to advance process understanding, control and qualification activities from late-stage development through launch/commercialization. The position is based at Allogene’s manufacturing facility in Newark, CA.

Requirements

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
Candidates must be authorized to work in the U.S.

Nice To Haves

Late-stage clinical and commercial experience preferred.
Cell therapy experience preferred.
Experience developing and implementing data solutions with machine learning and AI preferred.

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