Scientific Principal Engineer
Core
Lead clinical manufacturing activities for synthetic-molecule drug products from the internal pilot plant to external CMOs, ensuring process readiness and scale-up for oral solids, liquids, and parenteral applications.
Role type
Senior IC manufacturing sciences and technology engineer (pharmaceutical process engineering)
Builds
Clinical drug product material and manufacturing processes for new medicines
Domain
Pharmaceutical industry, drug product development, GMP manufacturing
Required skills
GMP regulated pharmaceutical development, process scale-up and tech-transfer, project leadership and coordination, risk management, manufacturing process optimization, cross-functional collaboration, regulatory compliance (FDA/GMP), validation and change management
Preferred skills
Advanced data sciences tools, process analytical technologies, continuous manufacturing, spray drying, extrusion
Technologies
Pilot-plant manufacturing platforms, tablet presses, continuous manufacturing lines, vial filling systems
Responsibilities
Coordinate clinical readiness activities in Drug Product Development and Clinical Supply Chain teams; manage risks and implement corrective actions for robust process development; establish and review manufacturing instructions and specifications; drive process improvement and optimization across international teams; act as PSES representative in development and supply chain project teams
Seniority
Senior, hands-on IC
