Project Specialist (External Manufacturing-Drug Product) in London

The External Manufacturing-Drug Product (EM-DP) Project Specialist is accountable for providing project oversight for Contract Manufacturing Organisations (CMOs) through the Procurement, Quality, Technical, Supply, + (PQTS +) team. The Project Specialist acts as the key point of contact between GSK and the CMO / supplier to drive technology transfer activities, mitigate risks and resolve issues. They may work alongside (or via) a Project Manager or the Supply Director to accomplish this. They will set up and deliver technology transfer schedules (through to product launch) in preparation for operationalising a single new supplier or new molecule / asset within the EM-DP network. In delivering your role you will leverage relationships with the supplier(s) to accelerate project timelines and deliver within budget. You will partner with the Supply Director on communications to GSK Senior Leadership teams (including managing escalations for the projects you are responsible for). You will work as part of the cross-functional PQTS + team and will be a key interface between internal and external product schedules (to drive a single schedule) and will manage (critical path) to ensure technical transfer deliverables are met.

For reference: The CMOs within EM-DP are inclusive of sterile drug product (e.g.; monoclonal antibodies, antibody drug conjugates, small molecules, vaccines, water-for-injection (WFI) and adjuvants.

Key Responsibilities:

• Key owner that develops and delivers the overarching project schedule that maintains critical path on the governed delivery dates and within budget.
• Able to assist in risk identification and mitigation of issues that may delay critical path delivery.
• Able to help articulate any issues or misalignments with the supplier / delivery plan and work with the relationship manager and/or Supply Director to mitigate with the supplier.
• Build a strong relationship with project team members across the PQTS+ and external suppliers based on trust and collaboration.
• Establish project organizational structure and maintain governance throughout the technology transfer.
• Key organizer of information for program milestone and escalation communication through established governance, across various leadership levels, as well as reporting of KPIs.
• Able to help Quality and MSAT organizations within GSK and the suppliers align on timely execution of all technology transfer deliverables.
• Overall project management, including appropriate and timely escalation of project priorities, risks and issues to ensure project delivery.
• Able to help drive continuous improvement on project delivery with the assigned CMO(s) or asset(s) with internal and external stakeholders.
• Ensure manufacturing know-how, relationship history and other technical knowledge is retained for future supply.

Location: You can be based at any GSK manufacturing site in the UK (e.g.; Ware, Barnard Castle, Worthing), or at GSK HQ (London, UK), or Wavre (in Belgium).

Travel: The successful applicant may need to travel as part of the delivery of their role to any of the sites in the network. We anticipate that travel will be a maximum of 10% of their time.

Basic Qualifications:

• Degree (or international equivalent) in Business, Supply Chain, Technical, Procurement, Biotechnology or Biologics related field, Engineering, Logistics, Finance or Quality.
• Experience in Pharmaceutical Industry with a GMP background.
• Experience in managing projects (at an internal or external facility).
• Understanding / knowledge of project governance and escalation processes including senior stakeholder communication and reporting.
• Understanding / knowledge of technical transfer & associated considerations (e.g.; risk/issue, timeline and budget management).
• Understanding / Knowledge of end-to-end Supply Chain Management (including financial implications / acumen).

Skills: Communication, Cross-Departmental Collaboration, Decision Making, Financial Acumen, Innovation, Leadership, Project Controls, Project Management, Project Management Governance, Project Planning, Project Tracking, Risk Management, Stakeholder Engagement, Stakeholder Management, Strategic Leadership.

Why GSK? Uniting science, technology and talent to get ahead of disease together. 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 get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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.