Director, Bioanalytical 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.
Position: Director, Bioanalytical Development
Location: South San Francisco, CA
Allogene is seeking an exceptional leader to serve as Director of Bioanalytical development in the Process and Product Development group within OpsTech. This individual will lead a subgroup with a focus on the development and utilization of biochemical techniques and assays to support CAR-T drug development and characterization. The ability to embrace an opportunity to navigate development and regulatory ambiguity with sound scientific principles in the emerging field of allogeneic cell therapy and be an innovative leader are characteristics that will enable success in this role.
Responsibilities include, but are not limited to:
- Build a bioanalytical function and lead a group of scientists responsible for the development and implementation of biochemical methods to characterize and release CAR-T-cell therapeutic drug products
- Develop and own the process related residual/impurity strategy for products moving into pivotal-stage clinical development and plans for BLA readiness
- Execution of experiments to develop, qualify, and transfer methods to internal groups, QC manufacturing operations and partners for the manufacture, characterization and release of products
- Work with process and quality colleagues to carry out assessment of complex raw materials used in the manufacture of drug product
- Provide analytical support during process design, optimization, characterization, validation, and transfer of cell therapy products internally
- Participate in building the information systems necessary for function
- Develop staff to meet current and future protein and biochemistry associated analytical needs, with an eye on new technologies, methods, and instrumentation
- Utilize experience and leadership skills to contribute to overall organizational effectiveness in Attribute Sciences
- Author and review detailed analytical reports and provide direct input/data/ analysis to support data package for regulatory submissions
- Deliver CMC supporting regulatory documentation required to rationalize process analytical, characterization, and release specifications
Position Requirements & Experience:
- MS/PhD scientist with 15+ of biotech experience, preferably with time in a cell or gene therapy environment, with increasing scientific and leadership responsibilities in analytical development.
- Demonstrated scientific knowledge and experience in the bioanalytical sciences of drug development and associated requirements throughout the development/clinical/commercial cycle with experience in training and transferring methods to QC groups in a manufacturing setting
- Exceptional ability to lead, develop talent and motivate a team within the specific function and in a team environment to maximize utilization of personal knowledge and experience in work with Process Development, QC, Manufacturing, Research, Translational Sciences, and CMC Regulatory
- Demonstrated track record with the development and/or commercialization of biotherapeutic drugs, preferably with additional experience in the cell or gene therapy field
- Proficiency in traditional bioanalytical HPLC, LC-MS, label-free biosensors methods, as well new technologies that can be applied in the cell and gene therapy field
- Experience working in a fast-paced matrix environment. Candidate must be agile and have the ability to effectively coordinate multiple priorities to meet goals
- Background working within an organization that interfaces with Quality and experience in contributing to regulatory submissions in the US and other jurisdictions
- 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.