About the role
AI summarisedThe Engineering Platform Lead for Oligonucleotides at GSK is responsible for ensuring robust, scalable, and GMP-compliant manufacturing platforms for oligonucleotide products. This role bridges Research, Development, and Manufacturing, providing technical expertise for platform selection, capital projects, and technology transfer to CMOs. The lead collaborates with cross-functional teams to embed quality by design and maintain product knowledge throughout the lifecycle.
BiopharmaFull-time
Key Responsibilities
- Ensure that appropriate platforms are used for GMP clinical trial material manufacture with scalability, manufacturability and commercial manufacture in mind.
- Provide technical expertise and lead aspects (project definition, equipment selection, procurement and commissioning / qualification) of internal GMP platform capital projects.
- Transfer platform knowledge as required to and from CMOs – including the support of assets that have been acquired or in licensed as well as those arising from internal discovery programmes.
- Represent CM&SC in terms of platform stewardship and collaborate with Drug Substance Development, Drug Product Development, GCMO Pilot Plants, CMOs and MSAT and GSC Manufacturing Sites.
- Support the generation and maintenance of Own and maintain product and process knowledge throughout the entire development life cycle, bridging Research / Early Development and Commercial Manufacturing Operations.
- Embed QbD, QF, PDVS, and GMPs in the GMP Mfg. network, ensuring Quality is respected while speed and agility are retained by aligning product development strategies with these key initiatives.
Requirements
- Bachelor's degree in chemical engineering, Mechanical Engineering, Chemistry, Bioengineering, Pharmacy, or other relevant discipline + experience in pharmaceutical manufacture and/or development.
- Experience with GMP manufacturing in Small Molecule drug substance, biological drug substance and sterile manufacturing operations across clinical and commercial manufacture.
- Experience of Process Design, Quality/ GMP, Project Management, Equipment maintenance and design in a pharmaceutical setting.
- Experience collaborating with cross-functional teams in a multicultural environment. Preparing and delivering written and verbal communications in a professional setting.
- Experience in leading a large matrix international organisation, build successful collaborations within and outside GMP manufacturing.
- Ability to work independently and set your own direction.
- Master or PhD in chemical engineering, Mechanical Engineering, Chemistry, Bioengineering, Pharmacy, or other relevant discipline (preferred).
- Would be advantageous to have manufacturing, scale-up or development experience of Oligonucleotide or peptide manufacture, and enzyme reactions (preferred).
- Matrix management, communication, synthesis and analytical capacity, presentation skills, spoken & written English, influencing, and flexibility (preferred).
- Experience in facility design, equipment procurement, capital projects, facility qualification and commercial manufacture are highly desirable (preferred).
- Solid understanding of regulatory requirements and the GSK QMS (preferred).
- A solid understanding of the connections with key stakeholders (Clinical, Regulatory, DS and DP development, CMC Project Teams and GCMO, CSC and GSC groups) is considered advantage (preferred).