Overview
The successful candidate will provide end-to-end technical ownership for assigned commercial products manufactured at site. Act as the primary point of contact for product and process knowledge, ensuring robust Product Lifecycle Management (PLM) across Product Control Strategy (PCS), Technical Risk Assessment (TRA), Continued Process Verification (CPV) and Process Performance Qualification (PPQ). Drive product performance, compliance and continuous improvement in partnership with Operations, Quality, Engineering and Global MSAT (e.g., Molecule Stewards) to deliver safe, compliant and efficient supply. This includes two permanent roles across Biologics, Inhalations and Devices and an additional fixed-term contract (FTC) within the Derms team, with shortlisting based on candidate experience.
Responsibilities
* Single point of accountability for assigned product(s): maintain and curate comprehensive knowledge of the product, process, CQAs/CPPs/MPPs, historical performance and critical learnings; share knowledge on site and with global partners as appropriate.
* Product Lifecycle Management: ensure local delivery of the Technical Lifecycle Plan (TLCP) owned by Molecule Stewards; maintain and continuously improve Product Control Strategy, Technical Risk Assessment, and Continued Process Verification.
* Performance monitoring & data analytics: proactively monitor product/process performance via CPV and site digital platforms where available; identify trends, lead data-driven problem solving and escalate risks with clear mitigation plans (e.g., CAPAs, governance boards).
* Change impact assessment & compliance: lead product impact assessments for changes (materials, process, equipment, methods, regulatory); ensure robust risk management and compliant execution through change control and validation lifecycle; support inspections, PPRs, dossier updates and audit readiness.
* Technical leadership: provide product expertise to deviations, complaints and investigations; lead/coach structured RCA and formal problem solving (e.g., FMEA, DMAIC) to prevent recurrence and improve robustness.
* New product introduction & transfers: provide technical input to NPIs and transfers (to/from site); ensure QbD-based processes, knowledge transfer and right-first-time PPQ; secure effective handover to Operations.
* Continuous improvement: identify and deliver improvement opportunities for yield, scrap, throughput and sustainability; sponsor and prioritize CI aligned to value-stream strategies.
* Collaboration & governance: partner with Global MSAT Molecule Stewards, Standards SMEs (e.g., PLM/CPV & Validation), Technical Execution teams, Quality and Production; contribute to product/technical forums (e.g., PTLTs) to align strategy and share best practices.
* GSK Barnard Castle is a key secondary manufacturing site and has invested heavily in industry 4.0 state of the art, bespoke equipment to support sustained new product introductions and volume increases, and as a key supplier of some of GSK's blockbuster products, the site contributes revenues of ~$2Bn annually., Uniting science, technology and talent to get ahead of disease together.
Required Qualifications
* BSc in Scientific or Engineering discipline or equivalent experience (e.g., Pharmaceutical Sciences, Chemical/Process Engineering or related).
* Substantial experience in pharmaceutical manufacturing or MSAT/Technical Operations with a track record of product/process improvement, investigations and successful validation/transfer execution.
Preferred Qualifications & Skills
* Detailed knowledge of relevant dosage form, plant equipment and analytical testing. Awareness of device/packaging processes.
* Level 1 Facilitator for TRAs ("Proficient" level as defined by the TRA competency framework).
* Knowledge of regulatory environment, particularly in markets where product is commercially available.
* Track record of improving processes and evaluating potential innovative technology areas relevant to product.
* Able to evaluate and interpret statistical data e.g. process capability, control charts, DoE, MSA.
* Thorough knowledge of GMP and EHS requirements; demonstrated in-depth knowledge of Quality by Design and risk management approaches.
* Able to contribute to and influence matrix teams and senior stakeholders; demonstrated ability to mentor operational staff and support functions.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law. Our culture supports an agile working environment and flexible opportunities; opportunities to explore with our hiring team are encouraged. For US-specific requirements related to candidate interviews, additional information may be requested to ensure compliance with transparency rules, including possible reporting of transfers of value.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK
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