Project Manager (EM-DS - External Manufacturing-Drug Substance) in Irvine

The External Manufacturing-Drug Substance (EM-DS) Project Manager is accountable for providing project leadership for Product Technical Transfers to external Contract Manufacturing Organization (CMO) Partners. These Technical Transfer (TT) projects can be from both internal and external donor sites and are delivered by a cross‑functional PQTS+ Team (Procurement, Quality, Technical, Supply + team) managed by the Project Manager in partnership with the CMO.

The Project Manager acts as the main point of contact between GSK and the supplier to drive technology transfer activities, mitigating risks and resolving issues, leveraging relationships to accomplish accelerated project timelines and delivery within budget, and communicating with GSK Senior Management while managing escalations. The Project Manager will manage a cross‑functional PQTS+ team and serve as the interface between internal and external product schedules to drive a single schedule and manage critical path(s) to ensure technical transfer deliverables are met. Projects are sponsored by the Supply Director or NPI director, to whom the PM reports.

Key Responsibilities

• Ownership (developing and delivering) of the overarching project schedule that maintains the critical path on the governed delivery dates and within budget.
• Responsible for project management for two Tech Transfers, suppliers and/or assets/molecules.
• Proactive risk identification and mitigation of issues that may delay critical path delivery.
• Clearly 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 point of contact for program milestones and escalation communication through established governance, across various management levels, as well as reporting of KPIs.
• Key interface between the Quality and MSAT (Manufacturing Science and Technology) organizations within GSK and the suppliers to ensure the timely execution of all technology transfer deliverables.
• Efficient and effective project management, including appropriate and timely escalation of project priorities, risks and issues to ensure project delivery.
• Identifies and drives 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 (Ware, Barnard Castle, Worthing, Irvine or Montrose), or at GSK HQ (London, UK), or at the Upper Merion or Zebulon sites (USA).

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 project management at an internal or external facility.
• Experience in management of project governance and escalation processes including senior stakeholder communication and reporting.
• Experience in delivery of strategic business projects with associated responsibility for risk/issue, timeline and budget management ideally of a Product Technical Transfer.
• Experience in product operational technologies as required by the supplier and product.
• Experience in managing globally dispersed virtual matrix teams.
• Experience in risk management and mitigation.
• Experienced in end‑to‑end Supply Chain Management and financial acumen.

Preferred Qualifications

• BS Degree or higher with PRINCE2 or PMP certification.
• Proficiency in Microsoft Project online and Microsoft Power BI.
• Operational experience in Drug substance supply chains and implementation of transfers and new product introduction & launch.
• Experience preparing and delivering presentations and negotiating agreements.
• Ability to effectively facilitate both large and small groups in virtual environment.

Equal Opportunity Statement

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 (including family medical history), military service or any basis prohibited under federal, state or local law.