Senior Director/Director, Attribute Sciences
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.
Position: Senior Director/Director, Attribute Sciences
Location: South San Francisco, CA
Allogene’s Attribute Sciences team in Process & Product Development (PPD) is seeking a candidate with a strong immunology background to lead cellular product characterization of engineered allogeneic T-cell therapies at various stages of clinical development. The ideal candidate will be responsible for the development of approaches to establish drug product and cellular starting material CQAs. The candidate will develop our drug product characterization strategy by working closely with Process Development, QC, Translational Sciences and Research to advance our understanding of CAR T cell-based therapies.
Responsibilities include, but are not limited to:
- Provide scientific, strategic, and technical leadership to the attribute sciences cellular product characterization team
- Responsible for analytical strategies for cellular product characterization, fitness, and potency, including the development and optimization of FIO in-process testing, donor starting material and drug substance and product characterization
- Support product CQA correlative strategy in partnership with Translational Sciences, Biometrics, Research, and Clinical; develop study and data analysis plans to support all products, but with particular emphasis on supporting products that transition into Phase 2/pivotal development
- Accountable for developing and executing strategies to enable the delivery of IND, INDa and BLA filings
- Execution of experiments to develop, qualify, and transfer methods to internal groups (QC manufacturing operations) or external CDMOs/CROs
- Utilize experience and leadership skills to contribute to overall organizational effectiveness in Attribute Sciences
- Author and review detailed analytical reports and provide direct input to support data packages for regulatory submissions
- Collaborate closely with other key functions to enable complex data/decisions within PPD and cross functionally
Position Requirements & Experience:
- PhD in relevant scientific discipline such as Immunology, Cell and Molecular Biology with 15+ years of relevant industry experiences
- Excellent and successful track record in leadership, people management, talent development and adept at managing interfaces with other functions
- Demonstrated deep understanding of immunology and cellular drug product development and characterization
- Strong scientific background in T-cell immunology is required
- Demonstrated ability to lead, build and motivate a team that partners with Process Development, QC, Manufacturing, Research, Translational Sciences, and CMC Regulatory
- Significant experience in driving characterization of cell and gene therapy products during drug development from Phase I to Pivotal registrational trials
- Advanced biochemical, molecular and cellular analytical platforms and related data analysis for multi-color flow cytometry, single cell analytical assay experience; flow expertise is important
- Prior experience with INDs and regulatory interactions is critical for role
- Skills in instrument/method automation and establishing scalable data acquisition and management capabilities within own function and outside would be highly valued
- Clear oral and written communication
- Candidates must be authorized to work in the U.S.
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.