Senior 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. For more information, please visit www.allogene.com, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.

About the role:

Allogene Therapeutics is seeking a highly motivated individual for the role of Senior Scientist, Drug Product Process Science to join the Process and Product Development department. The successful candidate will lead and participate in the activities related to drug product formulation, fill/finish, cryopreservation, dosage administration studies and process characterization of clinical-scale manufacturing processes in support of AlloCAR T™ clinical supply and commercialization. This person will also be involved in the technology transfer of the processes to our clinical manufacturing facility.

Responsibilities include, but are not limited to:

• Work collaboratively with cross-functional teams to develop robust and phase-appropriate formulation, aseptic fill/finish and cryopreservation processes.
• Design and execute studies to contribute to drug product process-improvement and process understanding.
• Establish and qualify representative scale down models (SDMs) in support of drug product process design.
• Design Drug Product process characterization strategies using Design of Experiment (DOE), engage cross-functional SMEs and execute PC activities to enable BLA submission
• Develop and execute in-use compatibility studies with analytical science team to deliver timely results, and collaborate with Clin Ops on development, implementation, and management of DAI and IPM
• Provide support for drug product process technology transfer, trouble shooting and serve as person-in-plant as required
• Provide support to drug product manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process improvements
• Thorough and timely documentation in electronic laboratory notebooks, data summarization and analysis.
• Author/review technical development reports, PSDs, Batch Records and DP-related sections in regulatory filings.

Position Requirements & Qualifications:

• Ph.D. in Pharmaceutics, Immunology, biomedical engineering, or related discipline with 2+ years of industry experience (or MS with 5+ years or BS with 8+ years).
• 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 formulations and fill/finish processes using Quality-by-Design (QbD) principles for autologous and/or allogeneic cell products.
• Experience with unit operation specific (i.e. filling, filtration, mixing, etc.) scale-down models, characterization, and scale-up
• Strong background in immunology, cell biology, aseptic primary cell culture and cell-based assays.
• Proficiency in statistical software (ie. JMP, or similar)
• Past work with cellular manufacturing in a cGMP environment is preferred.
• Experience in pharmaceutical development is a plus.
• 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 $120,000 to $150,000 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 with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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Last updated on Sep 30, 2024