About the role
AI summarisedThe Engineering Platform Lead plays a critical role within Process Technologies, Medicinal Global Clinical Manufacturing Organisation (GCMO), serving as a platform engineering and GMP subject-matter expert. This role ensures the delivery of efficient, timely, and cost-effective clinical trial manufacturing by bridging Research, Development, and Manufacturing across the end-to-end development lifecycle for oligonucleotide products.
BiopharmaOnsite
Key Responsibilities
- Ensure appropriate platforms are utilized for GMP clinical trial material manufacture with scalability and manufacturability in mind.
- Serve as the GMP manufacturing point of contact, representing CM&SC and collaborating with various development and manufacturing sites.
- Embed Quality by Design (QbD), Quality by Function (QF), Process Development and Validation Studies (PDVS), and GMPs within the GMP Manufacturing network.
Requirements
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Chemistry, Bioengineering, Pharmacy, or other relevant discipline.
- Demonstrated experience in pharmaceutical manufacture and/or development.
- Ability to ensure product quality, reproducibility, scalability, and long-term manufacturability.
- Experience bridging Research, Development, and Manufacturing phases.
- Familiarity with GMP environments and processes.
- Ability to collaborate closely with Drug Substance Development, Drug Product Development, GCMO Pilot Plants, CMOs, MSAT, and GSK manufacturing sites.