Job Description
About the role: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.
Responsibilities include, but are not limited to:- 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
Position Requirements & Experience:- 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.
We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes 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 $135,000 to $160,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.
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