Director, DP Workstream Leader – Molecule Parenteral; LAIs and Oligos

Position Summary

Director, DP Workstream Leader – Small Molecule Parenteral will lead the Drug Product (DP) workstream for sterile long‑acting injectables (LAI) and oligonucleotide modalities. In this role you will guide cross‑functional teams to design, develop and transfer robust sterile formulations and processes, partnering with clinical, regulatory, supply chain and external partners to deliver fit‑for‑purpose solutions. This role offers growth, meaningful impact on patients and alignment with GSK’s mission.

• Lead late‑stage development for New Chemical Entities drug products, from formulation to presentation and device design/development. Specifically lead Small Molecule programs for parenteral (e.g. Long Acting Injectables), and/or for new modalities (Oligonucleotides).
• Lead process development & scale‑up and technology transfer of drug product processes to manufacturing and packaging sites, ensuring robust and efficient production, including internal facilities and Contract Manufacturing Organizations, as required.
• Oversee formulation and fill‑finish process development, ensuring stability, compatibility, manufacturability, and product quality across clinical and commercial phases.
• Coordinate clinical and commercial supply readiness by aligning R&D, manufacturing, and supply chain activities, translating clinical and regulatory strategies into actionable technical deliverables, and building robust control strategies via cross‑functional partnership.
• Shape and align CMC and workstream strategies with program objectives, translating project priorities into clear functional direction and deliverables that influence other functions as required to deliver integrated solutions.
• Act as the strategic interface between the CMC project and the function, ensuring technical excellence, operational readiness, and end‑to‑end delivery of CMC deliverables and Product Quality Deliverables (PQDs).
• Anticipate and mitigate risks across quality, supply, and compliance dimensions, maintaining business continuity and regulatory robustness.
• Provide authoritative functional input to CMC regulatory submissions and ensure alignment with global standards, policies, and best practices to develop and file a robust control strategy.
• Collaborate effectively across internal and external partners, driving alignment, accountability, and timely decision‑making within a complex matrix environment.
• Demonstrate scientific and operational leadership to elevate standards, streamline execution, and enable continuous improvement across the portfolio.
• Apply critical thinking to assess the validity of arguments and data, form well‑reasoned opinions, and challenge potential biases at all project levels to drive superior solutions.

• Bachelor’s degree in Chemical/Biochemical Engineering, Chemistry, Biology, or related science discipline.
• 8 or more years of experience in leading cross‑functional projects and matrix teams representing a transversal or functional CMC development team at one or more project team levels within the pharmaceutical or biotechnology industries.
• 8 or more years of experience driving and executing on project strategies and the 360° aspects of medicine development, specifically for new chemical entities, their formulation and presentation.
• Experience working with late‑stage projects.

• PhD in Chemical/Biochemical Engineering, Pharmaceutics, Chemistry, Biology, or related scientific discipline.
• Experience with successful filing and approval would be advantageous.
• Experience in late‑stage development of small‑molecule drug candidates for parenteral long‑acting injectables and/or oligonucleotides.
• Demonstrated record of scientific achievement and a broad and integrated knowledge of the field.
• Understanding of relevant regulatory and compliance standards.

This role may be based in the United States (Upper Providence, PA) or United Kingdom (Stevenage or Ware). Working model: hybrid. Regular on‑site collaboration is expected. Remote work may be possible for focused tasks, but in‑person attendance is required for key meetings and team activities.