Principal Scientist- Sterile and Drug Product Development

GSK•Upper Providence, PA

2d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.