Principal Scientist- Sterile and Drug Product Development

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. We foster a culture ambitious for patients, accountable for impact, and committed to doing the right thing.

About the role

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. 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 and 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 be a 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.
• Contribute 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.

Requirements

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.

Qualifications

• 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 Qualifications

• 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

Benefits

Please visit the GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.