Senior Engineer, Manufacturing Science and Technology

Allogene Therapeutics•Newark, NJ

12d•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 Senior Engineer, Manufacturing Sciences and Technology. This role will be a hands-on role and will support technical and strategic initiatives to advance internal and external manufacturing 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 minimum of 8 years of directly related GMP pharmaceutical manufacturing experience.
Late-stage clinical and commercial experience preferred.
Knowledge of pharmaceutical manufacturing processes.
Cell therapy experience and/or direct experience with viral vector, gene-editing, or cellular starting material manufacturing 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%
Candidates must be authorized to work in the U.S.

Nice To Haves

Late-stage clinical and commercial experience preferred.
Cell therapy experience and/or direct experience with viral vector, gene-editing, or cellular starting material manufacturing preferred.

Responsibilities

Support trouble-shooting and continuous improvement of GMP manufacturing outcomes both internally and with external manufacturers
Support development and execution of key PPQ-enabling activities, including Process Control Strategy, PPQ protocol, E&L assessments, etc.
Implement and evolve integrated control strategy 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 supporting technology transfers
Provide reliable process requirement inputs to support business case and capital project decision-making
Ensure technical strong and compliant technical justifications for manufacturing deviations
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 Quality Assurance group, manage and ensure the timely review and release of product
Engage with broader manufacturing team to enable accomplishment of department goals
Other duties as assigned