Scientific Experienced Engineer
Core
Managing and executing clinical manufacturing activities for synthetic-molecule drug products in the internal Drug Product Pilot Plant, focusing on upscaling and fine-tuning formulation and processes for successful clinical manufacturing.
Role type
Senior Manufacturing Sciences & Technology Engineer (Pharmaceutical Process Engineering)
Builds
Clinical drug product material for oral solids, liquids, and parenteral applications via pilot-scale operations.
Domain
Pharmaceutical manufacturing / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulated pharmaceutical development, process scale-up, tech-transfer preparation, project leadership, risk management, manufacturing instruction establishment, cross-functional collaboration
Preferred skills
Parenteral manufacturing (sterile handling, aseptic filling), continuous manufacturing, process analytical technologies, qualification and validation systems
Technologies
Tablet presses, continuous manufacturing lines, vial filling systems, spray drying, extrusion
Responsibilities
Coordinate clinical readiness activities in the pilot plant, drive process improvement and optimization for tech transfers, establish manufacturing instructions and specifications, act as PSES representative in development and supply chain teams
Seniority
Senior, hands-on IC