Staff Scientist – Process Validation & Technology Transfer
Core
Own process validation strategy and lifecycle execution for biologics and viral vector programs, serving as technology transfer lead for incoming client and internal programs.
Role type
Staff Scientist (Process Validation & Technology Transfer)
Builds
GMP-compliant manufacturing processes for biologics and viral vectors
Domain
Biopharmaceuticals / Cell and Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation strategy, Continued Process Verification (CPV), lifecycle management, regulatory compliance (FDA/EMA/ICH), aseptic process simulation, statistical analysis (JMP/Minitab), deviation investigation, change control, technology transfer leadership
Preferred skills
CDMO experience, single-use technologies, upstream/downstream manufacturing knowledge
Technologies
JMP, Minitab
Responsibilities
Provide technical leadership for PV, CPV, and technology transfer; author and approve validation deliverables (PPQ protocols, control strategies); partner cross-functionally with Manufacturing, Quality, and Regulatory; manage validation documentation timelines; communicate technical risks to senior leadership and clients; lead initiatives to enhance validation efficiency.
Seniority
Senior, hands-on IC with program-lead capacity