Principal Scientist, Process Sciences

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.

Allogene is seeking a highly motivated Principal Scientist to lead the Pilot Plant function within Process & Product Development (PPD). This individual will serve as a technical and operational leader responsible for translating process development strategies into robust, scalable pilot-scale operations.

This successful candidate will leverage deep expertise in process development and scale-up to lead complex studies, guide organizational strategy, and drive cross-functional integration with Drug Product, MSAT, and Manufacturing. This role requires strong scientific leadership, operational execution, and the ability to influence programs across the organization.

• Lead the Pilot Plant team, overseeing execution of large-scale and engineering runs in support of process development, characterization, and technology transfer.
• Translate process development strategies into robust, executable at-scale cell therapy manufacturing operations.
• Ensure alignment across development, pilot, and manufacturing functions, enabling robust technology transfer to GMP.
• Lead the design and execution of high-impact process development and characterization studies using QbD principles.
• Identify and mitigate scale-dependent risks associated with cell therapy manufacturing platforms (e.g., Sepax, Xuri, Prodigy, etc.), ensuring robust process performance upon scale-up.
• Apply engineering principles, including fluid dynamics and gas and mass transfer, to support process understanding, scale-up, and robust manufacturing performance.
• Develop and implement closed, aseptic, automation strategies, including equipment/system evaluation, programming and optimization of cell therapy platform-specific systems.
• Drive end-to-end process integration, including thaw, activation genetic engineering, cell expansion, and fill/finish unit operations and associated at-scale equipment.
• Serve as the primary Process Sciences interface with Drug Product, Manufacturing, and MSAT functions.
• Ensure high-quality, timely documentation in electronic laboratory notebooks and Technical Reports and contribute to Regulatory Filings and responses to Regulatory questions as appropriate.
• Author and/or oversee preparation of technical reports, regulatory documents (i.e. IND/BLA sections), and scientific publications.
• Interpret complex datasets and communicate results to cross-functional teams and senior leadership.
• Act as a technical mentor, coaching scientists on study design, data interpretation, and scientific decision-making.
• Remain current with relevant cell therapy, immunology, and bioprocessing literature.
• Other duties as assigned

• Ph.D in Chemical Engineering, Bioengineering, Biochemistry, Molecular & Cell Biology, Immunology or related field with at least 7 years of relevant experience required; or MS with at least 10 years of industry experience; or BS with at least 12 years of industry experience.
• Extensive experience in process development and scale-up for biologics or cell therapy manufacturing.
• Demonstrated expertise in process characterization, DOE, and data-driven decision making.
• Experience using Python or R for analysis of complex datasets and development of automation solutions for cell therapy manufacturing platforms.
• Strong understanding of cell therapy manufacturing processes (i.e. gene editing, viral transduction, cell expansion, formulation).
• Experience supporting regulatory filings (IND/BLA) and process validation (PPQ).
• Proven track record of leading complex technical programs and cross-functional initiatives.
• Strong leadership,…