Executive Director, Process Engineering
Core
Lead the design, scale-up, and optimization of cell therapy manufacturing processes from early development through commercialization.
Role type
Executive Director, Process Engineering (Cell Therapy)
Builds
Cell therapy products (CAR-T, human stem cell therapies) for patients
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cell therapy process design and scale-up, GxP compliance, team leadership (30+ members), regulatory CMC package authoring, process validation strategies, make vs. buy decision making, multi-site organization management
Preferred skills
CAR-T and human stem cell therapy expertise, biologics manufacturing experience, automation integration, developing value-added manufacturing processes from scratch
Technologies
Single-use technology, automation tools, digital programs for process development
Responsibilities
Lead Late-Stage Process Development for Cell Therapies, Create and deploy global technical standards for cell therapy, Design and oversee process validation and qualification strategies, Build and manage a multi-site organization, Oversee resource allocation and make vs. buy decisions, Drive innovation by integrating internal and external expertise, Ensure compliance with regulations (GMP, HSE) and manage regulatory submissions, Provide technical leadership for new process development, Author and review regulatory CMC packages for IND/BLA filings, Oversee process transfer from development to GMP manufacturing, Fulfil post-approval commitments to health authorities
Seniority
Executive Director, strategic leadership & team building