Sterile Value Stream Director Barnard Castle

Sterile Value Stream Director Barnard Castle Site Name: UK - County Durham - Barnard Castle
Posted Date: Dec 1 2025
Posting Period: Ends 15 December 2025

Job purpose: As Sterile Value Stream Director, you will be accountable for leading end-to-end sterile operations across the Barnard Castle value stream. You will define and deliver the strategic transformation required to move the site from foundational rebuild to scale and excellence, ensuring safe, compliant, and cost-effective supply of sterile medicines to global markets. This is a visible, high impact, site based full time leadership role that requires experience in sterile manufacturing, strategic thinking, and proven capability to lead large scale change across people, processes, and technology.

A key element of the role is to create and sustain high performing management teams and to develop managers across the site who can embed and sustain operational excellence. The role covers a diverse range of product modalities including small and medium molecules, large molecules, monoclonal antibodies (mAbs), oligonucleotides and other advanced modalities.

Key responsibilities:

• Strategic Leadership: Define and execute the sterile value stream strategy to deliver Barnard Castle's vision for transformation, growth, and excellence. Translate global strategy into pragmatic, measurable site level plans
• Unify Manufacturing Teams: Break down silos and build a single, integrated one team manufacturing organisation across sterile operations, fostering alignment, shared accountability, and consistent execution across all manufacturing leaders
• Create High Performing Management Teams: Build, coach, and hold accountable a strong leadership team capable of delivering site objectives. Establish clear leadership structures, roles, and decision rights; set expectations and development plans; and ensure leaders model desired behaviours and drive performance
• Develop Leaders and Succession Plans: Implement leadership development programmes, mentorship and coaching frameworks, and succession planning to ensure bench strength and continuity. Promote a culture of compliance, continuous learning and leadership capability building at all levels
• Drive Change and Transformation: Lead change management programmes to rebuild foundational systems, embed new ways of working, and accelerate performance improvement. Sponsor and sustain lean/CI initiatives across sterile operations
• Digitalisation and AI Strategy: Shape and lead adoption of digital and AI enabled solutions to improve data driven decision making, predictive maintenance, process control, and workforce capability for future ready manufacturing
• Operational Delivery & Process Optimization: Oversee end to end sterile value stream processes including aseptic and terminal sterilisation, robotic filling, nano milling, and cold chain processing. Champion and drive productivity, yield, and throughput improvements using advanced technologies, ensuring approaches are appropriate to each modality (e.g., mAbs and oligonucleotides require specific cold chain, material handling and contamination control strategies)
• Quality, Compliance & Safety Accountability: Take ownership for product quality and regulatory compliance across sterile operations. Embed a safety-first culture and ensure robust systems and behaviours that meet GSK and global regulatory standards, including modality specific regulatory expectations for biologics, mAbs and oligonucleotides
• Performance Monitoring: Define and track KPIs across people, safety, efficiency, quality, cost, and delivery. Use data and insights to drive corrective actions, continuous improvement, and measurable outcomes
• Resource Allocation & Financial Stewardship: Prioritise and optimise allocation of materials, people, and equipment to meet production goals while controlling operational cost and capital investments
• Technology Optimization: Maximise value from technologies such as robotic filling, single use systems, HVLD and vacuum decay leak detection, inspection automation, RABS/CIP SIP systems, nano milling, and integrated eBRS systems. Ensure technology choices and validation strategies meet the needs of mAb and oligonucleotide manufacture where applicable
• Foundational Shifts & Integration: Lead the rebuild of core processes and systems and ensure seamless integration with GSK's global network - sharing best practice and aligning sterile manufacturing standards
• Stakeholder Collaboration: Partner with functional leaders - Quality, Regulatory, Engineering, Supply Chain, MSAT, Finance, and EHS - and with external suppliers and regulators to align strategy and delivery
• Talent & Culture: Build leadership capability, succession plans, and a high-performance team culture. Mentor and develop people to sustain long term operational excellence. Drive inclusion, empowerment and accountability across teams
• Capital & Investment: Accountability for the leadership, introduction of operational investments of new technologies, lines, equipment's and capabilities

Technologies & Capabilities You'll Work With

• Aseptic Filling: Robotic filling under VHP isolators (e.g., QF01), single use technology, peristaltic pumps, vacuum stoppering, syringe and vial lines
• Terminal Sterilisation: RABS filling lines, CIP/SIP systems, autoclaves and associated terminal sterilisation processes
• Inspection & Leak Detection: Automated visual inspection (Brevetti, Innoscan, Eisai), HVLD (Bosch), vacuum decay (Wilcomat), manual inspection
• Packaging & Assembly: Automated device assembly for syringes (Ypsomate, SSD, Molly), labelling, tray sealing, carton and case packaging systems
• Nano Milling & Cold Chain: Suspension nano milling (50L), cold chain small batch processing for high value biologics, specialised temperature controlled logistics and handling for mAbs and oligonucleotides
• Biologics Specific Considerations: Viral clearance/PRT strategy awareness for mAbs, stringent contamination control and hold time management, analytics and stability support appropriate for biologic modalities
• IT/Automation: Integrated IT and automation platforms including electronic Batch Records (eBRS), process control and analytics systems

Products Manufactured at the Site

• Large molecules: treatments for autoimmune diseases, severe asthma, oncology
• Monoclonal antibodies (mAbs): large molecule biologics targeting oncology, autoimmune and other indications
• Oligonucleotides: advanced modalities including siRNA, antisense oligonucleotides and related chemistries
• Small molecules: treatments for migraine, influenza, HIV/AIDS, HIV prevention
• Medium molecules: treatments such as for pulmonary arterial hypertension
• Other advanced modalities are also handled at the site

Qualifications & Experience

• Academic: Bachelor's degree in Business, Engineering, Operations, Supply Chain, Quality Management, or related field. Relevant professional certifications (Lean Six Sigma, PMP) highly desirable
• Experience: in sterile pharmaceutical manufacturing, including aseptic processing and terminal sterilisation; substantial experience leading large scale sterile operations and transformation programmes
• Leadership: Demonstrated ability to unify cross functional manufacturing teams, build high performing leadership teams, and drive change across complex organisations
• Leader Development: Proven experience designing and delivering leadership development, transformational change, succession planning, coaching and talent management programmes that uplift site capability and performance
• Technical Expertise: In depth knowledge of aseptic filling technologies, RABS/VHP processes, HVLD and vacuum decay leak detection, single use systems, and nano milling. Experience with eBRS and integrated automation preferred. Practical experience with biologics, including mAbs and oligonucleotide handling and associated process controls highly desirable
• Digital & AI: Proven track record implementing digitalisation and AI driven improvements within manufacturing environments
• Regulatory & Quality Accountability: Strong track record of driving compliance, regulatory readiness, and quality excellence across modalities including biologics
• Continuous Improvement: Demonstrated success applying lean methodologies and CI tools to deliver measurable operational improvements
• Interpersonal Skills: Exceptional strategic thinking, stakeholder management, communication, and people development skills
• Global Partnership: Experience collaborating with global strategy teams and aligning site level plans with network level objectives

Why this Role Matters? This is a transformational and highly visible role with significant strategic impact on GSK's ability to supply life saving sterile medicines worldwide. The Sterile Value Stream Director will directly influence patient safety, product quality, and the long term competitiveness of Barnard Castle through bold leadership, technical expertise, and a relentless focus on change and continuous improvement. By creating and developing high performing leadership teams and leaders across the site, the role will ensure sustainable delivery of excellence and resilience into the future, enabling safe, compliant, and scalable manufacture of small molecules, medium molecules, large molecules . click apply for full job details