The Vice President (VP) of Product Development will be responsible for state-of-the art cellular immunology laboratory process and product development requirements. This key role will lead the transition of 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 cellular immunology laboratory and support the development of IND-ready products. This key leadership role will support corporate-level Drug Discovery goals.
- Evaluate current cellular immunology and workflows, assays (e.g., TCR binding, cell killing and safety) and processes.
- Transition research-based 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.
Experience and Skills:
- Advanced degree in Life Sciences: PhD, MD, or MD / PhD.
- Strong background and experience in biologics process validation and product development.
- Experience in cellular immunology / biology is preferred.
- >7 years of experience leading product development.
- Demonstrated understanding of assay and product development requirements.
- Ability to work in a matrix environment and leverage cross-functional resources.
- Ability to function autonomously and drive strategic decisions.
- Team leader with the ability to work and manage others.
- Ability to work effectively with senior-level stakeholders, internally and externally.
- Strong communication and interpersonal skills and good judgment.
- Independent strategic thinker with strong ability to solve complex problems.
- Excited about an early stage company environment and driven to make a difference.