Principal Engineer, Manufacturing Science and Technology

Allogene Therapeutics • Newark, NJ

1d • $150,000 - $170,000

About The Position

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

Requirements

• 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.

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 101-250 employees