Director, MSAT (Drug Product)
Core
Lead process engineering for the design, qualification, startup, and registration of sterile drug product manufacturing (compounding, filling, inspection) and autoinjector/pen assembly at a new greenfield facility.
Role type
Director, MSAT Process Engineering
Builds
Sterile drug products (CVRM, metabolic medicines) and autoinjectors/multi-dose pens
Domain
Pharmaceutical manufacturing (sterile drug product)
Required skills
cGMP compliance, process validation, technology transfer, regulatory filing strategy, aseptic processing, microbial control strategies, risk assessment, equipment design, quality systems implementation, OEE optimization, supply chain risk management
Preferred skills
Smart factory/data analytics integration, advanced project management, stakeholder influence, complex problem solving
Technologies
Robotics, automation, digital tools, real-time data analytics
Responsibilities
Manage process engineering staff through design and qualification; co-lead project teams for cGMP compliance; provide technical input on production equipment design; implement quality systems and SOPs for validation and tech transfer; design comparability protocols; execute cross-functional risk assessments; ensure PPQ pre-requisites; participate in regulatory dossier creation; develop specifications for raw materials and IPCs; foster safety culture; drive OEE and COGS improvements; conduct business continuity risk assessments; provide training on complex technologies.
Seniority
Director, strategic leadership with hands-on technical oversight
