Director, Dp Workstream Leader – Molecule Parenteral; Lais And Oligos
Listed on 2026-07-21
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Pharmaceutical
Regulatory Compliance Specialist, Pharmaceutical Science/ Research
Location: Hertford Heath
Position Summary
The 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. You will partner with clinical, regulatory, supply chain and external partners to deliver fit‑for‑purpose solutions. We value curious scientists who are collaborative, clear communicators and who make data‑driven decisions to move projects forward.
This role offers growth, meaningful impact on patients and alignment with GSK’s mission of uniting science, technology and talent to get ahead of disease together.
The Late‑Phase Drug Product Workstream Leader (WSL) acts as the critical bridge between project strategy and functional execution, translating global Chemistry, Manufacturing, and Controls (CMC) and supply chain objectives into concrete functional plans. Accountable for all CMC deliverables across one or multiple projects or assets, the WSL exercises expert matrix leadership: mobilizing, aligning, and empowering cross‑functional teams through influence, coordination, and deep subject‑matter expertise.
As the primary advocate for their discipline within the CMC Matrix Team, the WSL ensures collaboration, milestone achievement, and integrated solutions in even the most complex environments, maximizing organizational and patient impact. The role is accountable for late‑phase project, meaning around the start of the development of Phase 3 or as agreed with the CMC Leaders.
Key Responsibilities- 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 (CMOs), 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 build robust control strategies via cross‑functional partnership.
- Strategic Alignment:
Shape and align CMC and workstream strategies with program objectives, translating project priorities into clear functional direction and deliverables influencing other functions as required to deliver integrated solutions. - Functional Matrix Leadership:
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). - Risk and Compliance:
Anticipate and mitigate risks across quality, supply, and compliance dimensions, maintaining business continuity and regulatory robustness. - Regulatory Excellence:
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. - Cross‑Functional Influence:
Collaborate effectively across internal and external partners, driving alignment, accountability, and timely decision‑making within a complex matrix environment. - Technical Thought Leadership:
Demonstrate scientific and operational leadership to elevate standards, streamline execution, and enable continuous improvement across the portfolio. - Critical thinking:
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…
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