Hybrid Engineering Platform Lead – Oligonucleotides

at GSK

• Job title: Engineering Platform Lead – Oligonucleotides
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Stevenage, United Kingdom

About the role

• Engineering Platform Lead at GSK focusing on high-quality clinical and commercial oligonucleotide products. Responsible for ensuring product and process quality in manufacturing with collaboration across teams.

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.

Benefits

• competitive salary
• annual bonus based on company performance
• healthcare and wellbeing programmes
• pension plan membership
• shares and savings programme
• hybrid working model