Senior Tech Transfer Specialist
Core
Leading the scale-up of clinical products from laboratory processes to large-scale production for early-stage clinical research, ensuring safety, efficiency, and quality.
Role type
Senior Manufacturing Science & Technology Specialist (Tech Transfer)
Builds
Clinical products for oncology, cardiovascular, renal, and metabolic disease research
Domain
Pharmaceutical manufacturing / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, process scale-up, change control management, technical risk assessment, project coordination, process optimization, filtration expertise, documentation management, cross-functional collaboration
Preferred skills
Product knowledge, Critical Quality Attributes (CQAs) understanding, process engineering background
Technologies
cGMP systems, Change Control systems, filtration equipment, process optimization tools
Responsibilities
Translate small-scale lab processes to large-scale production, manage Process Performance Qualification (PPQ) trajectories, coordinate full project lifecycle from planning to release, conduct technical risk assessments, develop product technology documentation, manage changes via Change Control system
Seniority
Senior, hands-on IC with project leadership
