Director, Parenteral Drug Delivery

This role will preferably be based in GSK Ware, UK but can also be based in strategic East Coast, US locations. The Global Supply Chain Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic platform direction and technical and operational support to ensure that GSK Global Supply Chain network, site goals and objectives are achieved, with determined strategy executed. MSAT is the keeper of the body of manufacturing process knowledge, creates the instruction set and ensures manufacturing operations stay aligned with the registered process, with the primary objective being to ensure manufacturing processes are in control, compliant, performant & cost-efficient and remain state of the art. MSAT's primary functions are to lead technology transfers, implement control strategies, provide technical process support across the product lifecycle, industrialising new products, platforms and new modalities into commercial manufacture and driving any product-related programs within the GSK Global Supply Chain. The Director, Parenteral Drug Delivery leads the diverse MSAT Global Device Engineering and Technology team focusing on delivering novel molecules in clinical and commercial biopharmaceutical products, deploying technical device applications and technologies as well as on delivering global technical device operations support and improvements to the existing supply chains. Director, Parenteral Drug Delivery oversees the technology transfer of drug delivery devices and combination product technologies from R&D, third party clients, and external Contract Manufacturing Organisations (CMOs) to and from GSK to other biopharmaceutical manufacturing sites. MSAT Device has responsibility for oversee and maintain combination product lifecycle management for all assets manufactured internally and externally, including technical, design control, verification and validation documentation, regulatory submission, inspection, and audit support. The Director of MSAT Device has direct responsibilities for continuously improved product quality among GSK assets containing drug delivery devices and combination products. The successful candidate will possess a high degree of emotional intelligence and be able to demonstrate their stakeholder influence and management skills. Are you ready to shape the future of healthcare? In this role you will

• Lead and manage a high performing, engaged, and motivated MSAT Global Device organization capable of delivering the MSAT drug delivery devices and integral combination product strategic priorities.
• Be responsible for the technology transfer and introduction of new processes globally and has direct accountability for the global device assembly technology transfer and validation activities to deliver an asset that can achieve yields and product attributes necessary for meeting commercial supply demand.
• Be responsible for global device and combination product lifecycle management for all device products commercially managed at global sites including post-approval regulatory change management, continued process verification, and continued increase of production yields and decrease of COGs.
• Provide technical drug delivery device and combination product information to enable site selection and sourcing decisions on potential new products from GSK or contract partners to be made.
• Work cross-functionally to communicate technical global device challenges and successes and influence at all levels including the R&D and supply chain teams to ensure both technical and commercial success of drug delivery devices and integral combination products for GSK., We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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• BSc, MSc or PhD in a related scientific discipline such as chemical engineering, chemistry, pharmacy, or pharmaceutical engineering - preferably Chartered / Professional Qualification
• Significant experience leading high performing teams
• Considerable experience in parenteral, device design, engineering, manufacturing and/or testing.
• Excellent project management, problem-solving, and decision-making skills
• Excellent communication, interpersonal and influencing skills; ability to set ambitious goals and successfully drive results, define priorities, manage and influence matrix team performance
• Working knowledge of scale-up, technical transfer and process change management / improvement, with knowledge in current Good Manufacturing Practices and US/EU/ROW regulations, Ph.D. or MS degree with significant experience in parenteral, device design, engineering, manufacturing and/or testing.
• In depth knowledge of respiratory, parenteral and standalone devices, as well as primary containers, platforms and technology evolutions.
• In depth knowledge of medical device manufacturing processes (injection moulding, automated assembly etc).
• Thorough understanding of market and regulatory trends
• Ability to work independently and follow through on assignments and delivery of the GSK GSC strategy without direction.
• Background and experience in leading platform / technology / matrix teams with specialist expertise
• Ability to concisely communicate status, needs, forecasts, risks and timelines effectively
• Ability to display a clear willingness to listen to others and demonstrate good interpersonal skills and works collaboratively in an effective manner to achieve objectives.
  
  We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicines and doses of vaccines in 2023.
We continue to modernise, so we can launch even more new products at speed whilst continuing to deliver across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. If you are interested in joining us, find out more: Annual Report 2023 Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.