Principal Scientist, Analytical Development
Process and Product Development | South San Francisco, CA | Full Time
About Allogene Therapeutics, Inc:
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™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy 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 Twitter and LinkedIn.
We are seeking a highly motivated Principal Scientist to join our Analytical Development team. The selected candidate will be responsible for developing cell-based characterization, in-process and release assays to support process development and manufacturing, then transferring selected assays to QC or CRO.
Responsibilities include, but are not limited to:
- Select, design and implement cell-based analytical methods to test process intermediates, drug substances and drug products during process development
- Exercise independent judgment in performing experimental methods, techniques, evaluation criteria for obtaining results, and data analysis
- Evaluate and transfer in appropriate assays and improve their performance
- Provide technical input to enhance current analytical methods
- Write protocols and development reports, and contribute to relevant regulatory filings
- Tech transfer selected assays to in-house and CMO QC groups
- As needed, support specification setting, qualification and validation of assays
- Present scientific results in team meetings and at conferences
Position Requirements & Experience:
- Ph.D. or equivalent in Immunology, Cell Biology or related field with 8+ years of assay development experience in biotech
- Experience in executing cellular characterization via cell functional assays, PCR and imaging platforms is required
- Experience with assay qualification and validation is plus
- Familiarity with FDA, ICH and GMP guidelines is preferred
- Highly organized, detail-oriented individual with strong
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.