Manufacturing (Senior) Scientist (Pilot-Plant)

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About the role

The Pilot-Plant at GSK’s Research & Development (R&D) site at Ware is a GMP clinical manufacturing and development facility that produces early-phase clinical supplies and supports product and process development for oral solid dose, respiratory medicines and low bio-burden manufacture (classified grade C).  The Pilot-Plant is focused on manufacturing clinical trial supplies for Phase 1 to Phase 2(b) studies, prior to transferring product over to the Global Supply Chain (GSC) for late-stage development and larger-scale manufacture.   Job Purpose: The Senior Scientist is instrumental in the manufacturing process for development and clinical trial material of appropriate quality and quantity for its intended use (in accordance with timelines agreed with key customers including Project teams, Clinical Supply Chain and QA).  You will play a key role in manufacturing the development and clinical trial material for assets progressing through the R&D phases into early and later-stage clinical studies.   The role operates in a manufacturing-focused R&D environment where you’ll validate and develop innovative processes, translate scientific ideas into robust, scalable ways of making new assets.  In this role, you’ll combine technical rigour, operational discipline and continuous improvement to ensure patients receive high-quality investigational medicines safely and on time.     Key Responsibilities (include).., • Manufactures products in compliance with cGMP and SOP's.  This includes set up, clean, inspect, and Cleaning Verification (including swabbing and validation inspection of equipment - required for activities).  Responsible for end-to-end manufacturing process including; availability of facilities/equipment, materials manufacture, in process checking/ sampling, production of relevant documentation and supports batch release in compliance with SOP's and safe operating procedures.  This extends to providing technical insight and oversight for the manufacture of supplies for Clinical Trials and other investigational purposes. • Ensures that training on all equipment and relevant procedures are completed and documented to Maintain compliance with SOP's and safe operating procedures (eg; COSHH compliance). • Provides technical input into batch record templates and subsequent generation of batch records.  Reconciles product into inventory, compiles batch documentation for the Team Leader review and liaises with PSQA to ensure batch release timings are agreed. • Where required, provides technical insight to oversee contract manufacturing of batches and support the transfer of technology to GSC sites (including working with third party vendors). • As required assists with any Deviation Investigation or audit action in accordance with SOP's and agreed timelines. • Recommends process and efficiency improvements identifying cost savings and knowledge value. • Leads and owns activities related to new equipment introduction and validation, including drafting and updating SOPs, Work Instructions and Risk Assessments, and partnering with development teams to translate process understanding into robust, scalable manufacturing processes appropriate for clinical supply. • Owns designated manufacturing areas for 5S, ensuring standards are defined, visual controls and routines are in place, and follow-up actions are driven to maintain a safe, efficient and audit-ready GMP environment. • Takes a lead role in generating and delivering Continuous Improvement activities, including planning and tracking CI actions to completion, and facilitating After Action Reviews (AARs) to ensure learnings are captured, communicated and embedded into Pilot-Plant ways of working.   Please Note:  Although this role is aligned to the GSK R&D function the position

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