The Vice President (VP) of Product Development will be responsible for Adaptive’s state-of-the art cellular immunology laboratory process and product development requirements. This key role will lead the transition of Adaptive’s T-cell receptor (TCR) discovery workflows from research and proof-of-concept to the next product development stage. The VP of Product Development is accountable for implementing end-to-end TCR screening and characterization workflows, assay validations and standardization. S/he will implement GLP-compliant processes, production-level controls, drive assay / method validations, maintain all necessary documentation, and evaluate workflow changes that could affect the production and control of a TCR product. The VP of Development will put in place strategies to scale Adaptive’s cellular immunology laboratory and support the development of IND-ready products. This key leadership role will support Adaptive’s corporate-level Drug Discovery goals.
- Evaluate current cellular immunology and TruTCRTM workflows, assays (e.g., TCR binding, cell killing and safety) and processes.
- Transition research-based TruTCR workflows into product and process development under GLP conditions.
- Lead product development strategy and establish TCR product validation and development plans, including product characterization and safety evaluation.
- Maintain relevant requisite TCR screening and product controls plus validation data.
- Develop and maintain detailed reports containing TCR screening and characterization development methods.
- Lead efforts to inform the development of real-time, patient-specific TCR screening process for a future fully personalized TCR-based cellular therapy.
- Coordinate cross-functionally with R&D, Operations and leadership to provide timely product development needs that inform infrastructure or resource requirements.