Principal Scientist- Sterile and Drug Product Development

GSK•Upper Providence, PA

1d•Hybrid

About The Position

At GSK, the R&D organization combines understanding of the immune system with cutting-edge technology to discover and deliver vaccines and medicines. The company aims to positively impact the health of 2.5 billion people by the end of the decade and focuses on accelerating significant assets that meet patients’ needs. The Principal Scientist will lead scientific work to develop safe, stable, and manufacturable sterile drug products, including long-acting injectables, monoclonal antibodies, and oligonucleotides. The role involves designing and conducting studies, interpreting results, making recommendations, and collaborating with colleagues across scientific disciplines, regulatory, and supply teams. The scientist will contribute to drug product development strategies, support development programs through scale-up and technology transfer, and may publish research and influence industry approaches. This is a hybrid role located in the United States. The employee is expected to work on-site part of the week and may work remotely for other tasks. Reasonable travel may be required.

Requirements

PhD in Pharmaceutics, Chemical Engineering, Biomedical Engineering, Chemistry, or a related scientific discipline; or an MS with 5 or more years of relevant experience; or a BS with 10 or more years of relevant experience.
Experience in formulation and process development for sterile, long-acting injectable, protein, or complex drug products.
Experience designing and executing stability and compatibility studies.
Experience analyzing data and interpreting physicochemical and analytical results.
Experience authoring technical reports and contributing to regulatory documentation.

Nice To Haves

Experience with long-acting injectables, ADCs, biologics, oligonucleotides, or advanced delivery systems.
Good understanding of physicochemical and biological properties and biopharmaceutics.
Experience with 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.
Familiarity with cGMP and regulatory requirements for manufacturing operations and documentation.
Strong collaboration and influencing skills in matrix team environments.

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 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 participate in matrix teams supporting product development.
Work across functional teams and external partners to support scale-up, technology transfer, and launch readiness.
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 laboratory practices.
Pursue opportunities to publish research and influence industry approaches.