Principal Process Scientist
Product Sciences | South San Francisco, CA | Full Time
Allogene Therapeutics is a biotechnology company with a mission to catalyze the next revolution in cancer treatment through the development of allogeneic chimeric antigen receptor T-cell (CAR T) therapy directed at blood cancers and solid tumors. Founded and led by former Kite Pharma executives who bring unrivaled clinical development acumen in cell therapy, Allogene is well-positioned to further the potential of allogeneic cell therapy for patients.
Allogeneic CAR T therapies are engineered from cells of healthy donors and stored for “off-the-shelf” use in patients. This approach eliminates the need to create personalized therapy from a patient’s own cells, simplifies manufacturing, and reduces the time patients must wait for CAR T treatment. The Allogene portfolio includes 16 pre-clinical T cell therapy assets and UCART19, an allogeneic CAR T therapy currently in Phase 1 development for the treatment of acute lymphoblastic leukemia (ALL). Through its notable partnerships, Allogene leverages pioneering technology platforms, including TALEN® gene editing technology, to progress its portfolio of immuno-oncology therapies. Allogene, with headquarters in San Francisco, California, is a Two River portfolio company formed with one of the largest Series A financings in biotechnology from an investment consortium which includes TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer, and Pfizer. For more information, please visit www.allogene.com, follow @AllogeneTx on Twitter and LinkedIn.
Allogene is seeking a Principal Process Scientist to support the development and characterization of clinical-scale manufacturing processes for Allogene’s CART therapies.
This individual will lead and contribute to the development, implementation and characterization of state-of-the-art processing technologies to deliver scalable and robust manufacturing processes, and support successful tech transfer for GMP manufacturing and release at a CMO. This position will also lead and contribute to the development of novel technologies and approaches to meet future CART manufacturing needs.
- Actively lead and contribute to development, implementation, characterization and successful execution of robust, state-of-the-art CART manufacturing processes.
- Support clinical-scale non-GMP/ GMP IND-enabling manufacturing operations, including Tech Transfer to CMO and support of successful GMP manufacturing of clinical material.
- Lead and contribute to relevant and impactful innovation programs to enhance CART manufacturing technologies/ capabilities and work-processes (such as alternate transfection/ cell engineering strategies, media development, disposable/ closed production systems and automation), aligned with emerging business drivers and regulatory expectations.
- Contribute to Project Technical Teams and communicate and collaborate effectively to ensure effective interactions with all stakeholder groups.
- Ensure high-quality, timely documentation in electronic laboratory notebooks and Technical Reports and contribute to Regulatory Filings and responses to Regulatory questions as appropriate.
- Present data/strategy to scientists (and management) in internal venues (technical meetings, Project Team meetings) as appropriate.
- Remain current with the process engineering and chemistry literature. May collaborate and author external publications and present research at external conferences.
- Other duties as assigned.
- PhD in Chemical Engineering, Biochemistry, Molecular & Cell Biology, Immunology or the related field with 6-10 years of relevant experience required.
- Experience with prior Gene & Cell Therapy manufacturing preferred, but not required
- A demonstrated foundational understanding of mammalian or primary cell culture, biochemistry, molecular & cell biology and immunology (required for enhanced product & process understanding).
- Experience with continuous manufacturing processes including operation in upstream genetic modification and bioreactor/WAVE expansion, as well as downstream purification/separation, formulation/fill and cryopreservation.
- Experience in media development, disposable processing technologies and automation of manufacturing processes.
- Excellent knowledge of chemical engineering principles including: reaction kinetics, reactor design, chemical thermodynamics, heat and mass transport, engineering statistics, modeling and simulation.
- Working knowledge of application of in-situ analysis tools to process understanding including: FTIR, FBRM, UV/Vis.
- Experience in genetic modification of cells using gene edit and gene delivery technologies.
- Ability to work in a fast-paced, startup environment.
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established 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.