Senior/Executive Director, Cell Process Development
Senior or Executive Directors in Cell Process Development oversee the end-to-end design, optimization, and scale-up of cell therapy manufacturing processes. They play a strategic leadership role, ensuring products are robust, regulatory-compliant, and scalable from preclinical through commercial phases.
Responsibilities include:
Defining process development strategy – Aligning cell expansion, differentiation, and harvesting methods with CMC and clinical timelines.
Leading multi-disciplinary teams – Including scientists, engineers, QA, and tech transfer specialists across upstream and downstream platforms.
Implementing closed and automated systems – To improve consistency, reduce contamination risk, and support GMP readiness.
Engaging with regulators and partners – Supporting IND/CTA submissions and participating in joint development or CDMO collaborations.
Building high-functioning departments – Hiring, mentoring, and inspiring cross-site teams within cell and gene therapy development pipelines.
Candidates typically have 10+ years of experience in cell processing, strong regulatory insight, and a proven track record in ATMP development.