Principal Scientist- Sterile and Drug Product Development

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 You will lead scientific work to develop safe, stable, and manufacturable sterile drug products, including long-acting injectables, mAbs and oligonucleotides. You will design and run studies, interpret results, and make clear recommendations. You will work closely with colleagues across scientific disciplines, regulatory, and supply teams. We value curiosity, clear communication, and a focus on patients. This role offers growth, real impact on development programs, and the chance to unite science, technology and talent to get ahead of disease together. Responsibilities Design, plan and execute formulation and process development studies for sterile and complex drug products. Develop/optimize long-acting injectables, antibody drug conjugate (ADC), protein or oligonucleotide formulations. Develop phase appropriate formulations to support clinical studies and ultimately commercialization. Interpret experimental results and provide clear recommendations to project teams. Lead stability, compatibility, and container-closure assessments to support regulatory submissions. Prepare technical reports, study protocols, and documentation needed for product development and transfer. Lead drug product development matrix teams and/or member of matrix teams supporting product development. Work across functional teams and external partners to support scale-up, technology transfer, and launch readiness, and participate in preparing regulatory documents. Contributes to Drug Product Development strategies. Propose and deliver innovative approaches to achieve project goals Mentor colleagues, review data quality, and contribute to continuous improvement of lab practices. Opportunities to publish research and influence industry approaches. Why You? This role is hybrid and located in the United States. You will be expected to work on-site part of the week, with flexibility to work remotely for other tasks. Reasonable travel may be required. Basic Qualification PhD in Pharmaceutics, Chemical Engineering, Biomedical Engineering, Chemistry, or related scientific discipline; or MS with 5+ years’ relevant experience; or BS with 10+ years’ relevant experience. Experience in formulation and process development for sterile, long acting injectables, protein or complex drug products. Experience designing and executing stability and compatibility studies. Experience with Data analysis and interpreting physicochemical and analytical results. Experience authoring technical reports and contributing to regulatory documentation. Preferred Qualification Experience with long acting injectables, ADC, biologics, oligonucleotides, or advanced delivery systems. Good understanding of physico-chemical, biological properties and biopharmaceutics. Experience in sterilization techniques. Familiarity with container-closure integrity and primary packaging assessments. Experience with technology transfer and scale-up to manufacturing. Knowledge of statistical design of experiments (DOE) and technical risk assessment methods. Experience contributing to regulatory submissions and responding to regulatory questions. Familiar with cGMP and regulatory requirements for manufacturing operations and documentation. Strong collaboration and influencing skills in matrix team environments. 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

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Why GSK? Unite 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. 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. If you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. #J-18808-Ljbffr GlaxoSmithKline