Director, Manufacturing Science and Technology (MSAT)
Core
Lead Manufacturing Science and Technology (MSAT) strategy and execution for clinical-stage autologous cell therapy programs, ensuring robust, compliant, and efficient manufacturing processes from development through PPQ and lifecycle management.
Role type
Director, Manufacturing Science and Technology (MSAT)
Builds
Clinical-stage autologous cell therapy products (TIL therapy) for patients with metastatic melanoma and non-small cell lung cancer
Domain
Biopharmaceuticals / Cell and Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
End-to-end MSAT strategy, CPP/CQA definition, statistical process control, tech transfer management, regulatory CMC documentation, deviation investigation, risk management (FMEA/HAZOP), CDMO oversight
Preferred skills
Autologous cell therapy background, late-stage development experience, BLA submission readiness
Technologies
None explicitly listed
Responsibilities
Serve as lead MSAT interface to CDMOs for clinical manufacturing oversight; Define and maintain CPPs, CQAs, and control strategies; Lead PPQ strategy and execution; Oversee authoring and review of batch records and validation reports; Drive governance of tech transfer plans and process validation documentation; Author and review CMC sections for regulatory submissions; Lead complex manufacturing investigations and change controls; Provide technical leadership for risk management (SIPOC, FMEA, HAZOP); Prepare teams for PAI and FDA interactions
Seniority
Director, strategic leadership with hands-on technical execution
