Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade.
Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture of ambition for patients, accountability for impact, and commitment to doing the right thing. We accelerate assets that meet patients’ needs and have the highest probability of success, uniting science, technology, and talent to get ahead of disease together.
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, partnering with clinical, regulatory, supply chain and external partners to deliver fit‑for‑purpose solutions.
You will value curiosity, collaboration, clarity of communication, and data‑driven decision‑making to advance projects. This role offers growth, meaningful impact on patients, and alignment with GSK’s mission.
The Late‑Phase Drug Product Workstream Leader (WSL) acts as the critical bridge between project strategy and functional execution, translating global CMC and supply chain objectives into concrete functional plans.
Accountable for all CMC deliverables across one or multiple projects, the WSL exercises expert matrix leadership, mobilizing, aligning, and empowering cross‑functional teams through influence, coordination, and deep subject‑matter expertise. The role is accountable for late‑phase projects, from the start of Phase 3 development or as agreed with CMC leaders.
Key Responsibilities
- Lead late‑stage development for New Chemical Entities drug products, from formulation to presentation and device design/development; lead Small Molecule programs for parenteral (e.g. Long Acting Injectables) or 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 building robust control strategies through cross‑functional partnership.
- Strategic Alignment: Shape and align CMC and workstream strategies with program objectives, translating project priorities into clear functional direction and deliverables; influence 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.
Basic Qualifications
- Bachelor’s degree in Chemical/Biochemical Engineering, Chemistry, Biology, or related science discipline.
- 8 or more years of experience 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.
Preferred Qualifications
- 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.
Location and Working Model
- 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.
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.
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