Principal Engineer, Manufacturing Science and Technology

About Allogene:

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

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 Principal Engineer, Manufacturing Sciences and Technology. This role will be a hands-on role and will provide technical and strategic leadership to advance activities from late-stage development through launch/commercialization.

The position will be accountable for technical oversight of CAR-T PPQ planning and execution. The position could be based either at Allogene headquarters in South San Francisco or Allogene’s manufacturing facility in Newark, CA

Responsibilities include, but are not limited to:

• In partnership with Quality, Process Development and Regulatory, develop strategy for Process Performance Qualification in support of licensing application
• Lead development and execution of key PPQ-enabling activities, including Process Control Strategy, PPQ protocol, E&L assessment, etc
• 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 at least 8 years of directly related GMP pharmaceutical manufacturing experience (direct experience with CAR-T manufacturing strongly preferred).
• Knowledge of pharmaceutical manufacturing processes (cell therapy experience preferred).
• Late-stage clinical and commercial experience (experience with CMC regulatory submissions preferred).
• Highly developed leadership skills with the ability to effectively organize and lead teams without direct reporting relationships.
• 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, strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment
• 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 $150,000 to $170,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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