Analysis Skills, Asepsis, Autoimmune Disease, Biomedical Engineering, Biotech and Pharmaceutical, Cancer, Cell Analysis, Cell Biology, Cell Cultures, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Data Visualization Tools, Diversity, Documentation, Documentation Plan, Drug Products, Establish Priorities, Experiment Design, Failure Mode and Effects Analysis (FMEA), Identify Issues, Immunology, Laboratory Notebook, Legal, Manufacturing Requirements, Manufacturing/Industrial Processes, Organizational Skills, Pharmaceutics, Process Development, Process Engineering, Product Development, Product Support, Quality Control, Regulatory Submissions, Reporting Skills, Sales Pipeline, Scientific Data Management System (SDMS), Startup, Statistics, Technical Writing, Time Management, United States Department of Energy (DOE), Writing Skills
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 Scientist, Drug Product Process Science (Contractor) to join the Process and Product Development department. The successful candidate will design, execute and contribute to the activities related to process characterization for BLA readiness, as well as drug product formulation, fill/finish, cryopreservation, dosage administration studies of clinical-scale manufacturing processes in support of AlloCAR T clinical supply and commercialization.
Responsibilities include, but are not limited to:
- Design and execute studies to contribute to drug product process characterization activities to enable BLA submission.
- Establish and qualify representative scale down models (SDMs) to support drug product process characterization studies.
- Participate in cross-functional process FMEA activities and contribute to process characterization design.
- Apply statistical tools and Design of Experiments (DOE) methodologies to evaluate process robustness and characterize process parameters.
- 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 needed
- Actively participate in cross-functional activities with PD, AD, MSAT, and QC teams
- Thorough and timely documentation in electronic laboratory notebooks, data summarization and analysis.
- Author technical development reports, PSDs, Batch Records and DP-related sections in regulatory filings.
Position Requirements & Qualifications:
- M.S. in Pharmaceutics, Immunology, biomedical engineering, or related discipline with 5+ years of industry experience (or BS with 8+ years).
- Experience supporting development, characterization, scale-up, or commercial manufacture of drug product processes, including formulation, fill/finish, cryopreservation, storage, or administration of biologics or cell therapy products.
- Working knowledge of cell biology, aseptic cell culture and cell-based analytical methods.
- Experience applying Design of Experiments (DOE), statistical analysis, and data visualization tools (JMP, Spotfire, or equivalent) to process development or characterization studies.
- Experience with electronic data systems and ELNs (e.g., Benchling or similar platforms) for experimental documentation, data analysis, and collaboration is preferred.
- Familiarity with cGMP manufacturing and regulatory expectations for biologics or cell therapy products is a plus.
- Strong technical writing skills and experience preparing technical reports, protocols, study plans, and development documentation.
- 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 $50.00 to $58.00 per hour. 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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