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 ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D
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.
Why You?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- 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
Preferred Qualification
If you have the following characteristics, it would be a plus:
- 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.
#GSKCareers
What we value
You will join a team that puts patients first and values transparency, respect and integrity. We want people who communicate clearly, collaborate across disciplines and take responsibility for delivering high-quality results. We welcome candidates who bring curiosity, empathy, learning agility and a commitment to inclusion.
Ready to apply?
If you are excited to lead drug product development for sterile LAI and oligonucleotide medicines, please apply and tell us how your experience will advance our work to get ahead of disease together.
Skills
Drug Delivery, External Manufacturing, Medical Device Evaluation, Molecular Modeling, Pharmaceutical Formulations, Pharmacokinetics, Product Design, Product Management, Product Planning, Product Strategies, Quality by Design, Regulatory Filings, Stability Testing, Technology Transfer
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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.
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