Senior Principal Engineer, Manufacturing Science and Technology
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.
This person will guide and support efforts of manufacturing science and process engineering across functional boundaries that develop capability supporting end to end CAR T manufacturing. This will include: 1) capability to scale up processes robustly and transfer to facilities 2) support manufacturing facility design, licensure, and health authority inspections 3) partner with and oversee contact manufacturing 4) the oversight of staff.
Responsibilities include, but are not limited to:
- Strong technical and strategic leadership to influence the growth and direction of a rapidly growing company and therapeutic field
- Experience leading complex, cross-functional projects, requiring negotiation, risk taking and risk management.
- In-depth knowledge of GMP and regulatory expectations and experience with regulatory inspections.
- 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 scale-up and transfer from bench scale to manufacturing
- Implement and evolve integrated control strategy for allogeneic CAR-T therapies.
- Applies advanced engineering principles to develop standard approaches for new and existing manufacturing systems to ensure robust product stewardship and technical oversight that facilitate robusts technology transfer and scale-up of cellular based therapies to provide clinical supply.
- Able to establish long-range technology roadmaps and business cases for the Process Development and Manufacturing by identifying, analyzing and developing new technology and business opportunities.
- Expected to lead projects of significant scope and importance to the company. Responsible as the primary technical contact for large cross functional projects. Leads development of new technical areas.
- Applies and develops highly advanced technologies, scientific principles, theories and concepts to meet the needs of the Process Development and Manufacturing
- Develop and mentor technical staff to thrive in a dynamic and scientifically demanding environment.
- Assist development of a long-term, commercial manufacturing strategy for allogeneic CAR-T therapies.
- Develop sophisticated process modeling and risk management capabilities to guide 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.
Position Requirements & Experience:
- BS in engineering with at least 15 years, MS in engineering with 12 years, or PhD with 10 years’ 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
- Exhibits an exceptional degree of ingenuity, creativity, resourcefulness and technical leadership.
- 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.