Associate Director / Device Lead
Core
Technical owner of the Device platform for Global MSAT Drug Delivery and Aseptic Technology, accountable for device delivery into GSK Manufacturing sites and global supply base operations.
Role type
Senior IC Device Lead / Associate Director
Builds
Robust supply strategy for the Device platform, including mould tool & assembly asset validation, technology transfer from R&D, and global device/component manufacturing processes.
Domain
Pharmaceutical/Medical Device Manufacturing (Drug Delivery Devices, Aseptic Technology)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical Device Manufacturing, GMP/Regulatory Compliance (FDA 21 CFR 820, EU MDR, ISO 13485), Technology Transfer, Risk Management, Lifecycle Management, Injection Mould Tooling Design, Device Polymers and Materials Engineering, Process Optimization, Project Leadership
Preferred skills
Pharmaceutical Development, Metrology & Plastics Testing, Global Matrix Management, Data Science/Digital Data Infrastructure, Mathematical Modelling, Device Automated Assembly
Technologies
FDA 21 CFR 820, EU MDR 2017/745, ISO 13485, ISO 14971, ISO 10993, GxP Regulations, ICH Guidelines
Responsibilities
Interface between Device/Component suppliers and GSK MSAT site teams; Deliver supply strategy and validate mould tools/assembly assets; Lifecycle manage the Device Platform and drive Technology Transfer; Ensure global manufacturing processes meet specifications; Maintain Device design and regulatory DHF/Technical file requirements; Drive innovation in novel device technologies and sustainable manufacturing; Perform and lead risk management activities.
Seniority
Senior, hands-on IC with strategic oversight
