Principal Scientist, Drug Product Process Science

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 Therapeutics is seeking a highly motivated individual for the role of Principal Scientist Drug Product Process Science to join the Process and Product Development department. The successful candidate will play a critical role in drug product process characterization and BLA readiness for allogeneic CAR-T therapies including but not limited to process characterization design and execution and regulatoryready documentation in support of BLAenabling and BLA submission activities and will work closely with crossfunctional partners across MSAT Quality Regulatory Analytical Sciences and Clinical Operations.

Responsibilities include but are not limited to:

• Design Drug Product process characterization strategies using Design of Experiment (DOE); Lead the design execution analysis and documentation of Drug Product process characterization studies to enable BLA submission.
• Establish and qualify representative scale down models (SDMs) in support of drug product process design and process characterization.
• Develop and execute in-use compatibility studies and collaborate with Clin Ops on the development implementation and management of DAI and IPM
• Lead the development and continuous improvement of DP data organization analysis and visual workflows to enable efficient protocol execution and support regulatory readiness
• Provide DP technical leadership for large scale manufacturing runs including person-in-plant support as needed.
• Ensure timely complete and inspectionready documentation including protocols reports ELN records and regulatory content.
• Author and review BLAenabling technical documents including risk assessments protocols development reports process descriptions control strategy/validation/PPQsupporting documentation and Module 3 DP sections (IND and BLA).
• Contribute to the establishment of DP best practices and mentoring of future DP hires as the team scales.

Position Requirements & Qualifications:

• Ph.D. in Pharmaceutics Immunology biomedical engineering or related discipline with at least 7 years of industry experience; or MS with at least 10 years of industry experience; or BS with at least 12 years of industry experience.
• Experience working in the pharmaceutical or biotechnology industry that includes elements of new product development process characterization formulation development equipment design and implementation technology transfers statistical process control (SPC) and statistical design and analysis of experiments
• Hands-on experience developing drug product processes using Quality-by-Design (QbD) principles for autologous and/or allogeneic cell therapies preferably including late-stage or BLA-enabling programs.
• Experience designing and executing process characterization and/or PPQ-related studies for biological or cell therapy products.
• Prior contribution to regulatory submissions (e.g. IND BLA) is highly preferred.
• Experience with electronic data systems and ELNs (e.g. Benchling or similar platforms) for experimental documentation data analysis and collaboration is preferred.
• Experience in pharmaceutical development is a plus.
• Demonstrated ability to operate effectively in highintensity execution phases with overlapping protocols data analysis and reporting timelines.
• Strong background in immunology cell biology aseptic primary cell culture and cell-based assays.
• Proficiency in statistical software (e.g. JMP or similar)
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
• Ability to work independently in a fast-paced startup environment as well as work collaboratively in a highly interactive team environment.
• Candidates must be authorized to work in the U.S.

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. The expected salary range for this role is $155000 - $180000 per year. Actual pay will be determined based on experience qualifications geographic location business needs and other job-related factors permitted by law.

As an equal opportunity employer Allogene 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. We also embrace differences in experience and background and welcome diversity of opinions and thought designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.