Director, Process Development
Process and Product Development | South San Francisco, CA | Full Time
About Allogene Therapeutics, Inc:
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™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
The Director, Process Development will lead and guide the creation of manufacturing science and process engineering capability across end to end CAR T manufacturing. This will include:
- Capability to scale up processes robustly and transfer to facilities
- Support manufacturing facility design and licensure, including health authority inspections
- Partner with and oversee contact manufacturing
- Hiring and oversight of staff responsibility
Responsibilities include, but are not limited to:
- Provide strong technical and strategic leadership to influence the growth and direction of a rapidly growing company and therapeutic field
- Experience leading complex and cross-functional projects requiring negotiation, risk taking and risk management.
- Build team and develop capabilities to ensure robust product stewardship and technical oversight to enable technology transfer and scale-up of cellular based therapies to provide clinical supply.
- Develop and mentor technical leaders to thrive in a dynamic and scientifically demanding environment.
- Translate laboratory/pilot scale cell therapy manufacturing technologies and processes to clinical and commercial manufacturing scale to ensure reliable and compliant supply.
- Advance engineering fundamentals associated with unit operations including best practices for transferring to manufacturing
- Implement and evolve integrated control strategy for allogeneic CAR T therapies.
- Participate and contribute to IND/BLA filings and regulatory interactions to gain approval of filings
- Develop long-term commercial manufacturing strategy for allogeneic CAR T therapies.
- Develop sophisticated process modeling and risk management capabilities to guide process design, facility design and facility fit
- Provide reliable process requirement inputs to support business case and capital project decision-making
- Manage strategic partnerships with external manufacturers (CMOs) of CAR T therapies
- Ensure technical strong and compliant technical justifications for manufacturing deviations
- Align technical strategy with corporate strategy in advancing allogeneic CAR T therapies.
- Other duties as assigned
Position Requirements & Experience:
- PhD in engineering and at least 15 years of experience in process development and operational roles in the biotechnology or pharmaceutical industries
- Prior process development leadership supporting technology transfer and new product introduction
- Demonstrated success applying advanced analytics to manufacturing and process development data
- Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines
- Ability to work independently and as part of a team
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene Inc. 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.