Principal Scientist- Sterile and Drug Product Development
GSK
August 12, 2026
Remote friendly (Collegeville, PA)
United States
Clinical Research and Development
Position Summary
- Lead scientific work to develop safe, stable, and manufacturable sterile drug products (long-acting injectables, mAbs, oligonucleotides).
- Design and run studies, interpret results, and make clear recommendations.
Responsibilities
- Design, plan, and execute formulation and process development studies for sterile/complex drug products (e.g., long-acting injectables, ADC, protein, oligonucleotide formulations).
- Develop phase-appropriate formulations to support clinical studies and commercialization.
- Interpret results; provide recommendations to project teams.
- Lead stability, compatibility, and container-closure assessments for regulatory submissions.
- Prepare technical reports, study protocols, and documentation for product development/transfer.
- Lead or support matrix teams for drug product development.
- Coordinate cross-functionally and with external partners for scale-up, technology transfer, and launch readiness; support regulatory document preparation.
- Contribute to drug product development strategies; propose innovative approaches.
- Mentor colleagues, review data quality, and improve lab practices.
Basic Qualifications
- PhD (Pharmaceutics, Chemical Engineering, Biomedical Engineering, Chemistry, or related) OR MS + 5+ years OR BS + 10+ years.
- Experience in sterile formulation/process development for long-acting injectables/protein/complex drug products.
- Stability and compatibility study design/execution.
- Data analysis; interpret physicochemical/analytical results.
- Author technical reports and contribute to regulatory documentation.
Preferred Qualifications
- Experience with long-acting injectables, ADC, biologics, oligonucleotides, advanced delivery systems.
- Knowledge of physico-chemical/biological properties and biopharmaceutics.
- Sterilization experience; container-closure integrity/primary packaging assessments.
- Technology transfer/scale-up; DOE and technical risk assessment.
- Regulatory submission experience; cGMP/regulatory requirements.
Location
- Hybrid role in the United States; on-site part of the week; some travel may be required.
- Lead scientific work to develop safe, stable, and manufacturable sterile drug products (long-acting injectables, mAbs, oligonucleotides).
- Design and run studies, interpret results, and make clear recommendations.
Responsibilities
- Design, plan, and execute formulation and process development studies for sterile/complex drug products (e.g., long-acting injectables, ADC, protein, oligonucleotide formulations).
- Develop phase-appropriate formulations to support clinical studies and commercialization.
- Interpret results; provide recommendations to project teams.
- Lead stability, compatibility, and container-closure assessments for regulatory submissions.
- Prepare technical reports, study protocols, and documentation for product development/transfer.
- Lead or support matrix teams for drug product development.
- Coordinate cross-functionally and with external partners for scale-up, technology transfer, and launch readiness; support regulatory document preparation.
- Contribute to drug product development strategies; propose innovative approaches.
- Mentor colleagues, review data quality, and improve lab practices.
Basic Qualifications
- PhD (Pharmaceutics, Chemical Engineering, Biomedical Engineering, Chemistry, or related) OR MS + 5+ years OR BS + 10+ years.
- Experience in sterile formulation/process development for long-acting injectables/protein/complex drug products.
- Stability and compatibility study design/execution.
- Data analysis; interpret physicochemical/analytical results.
- Author technical reports and contribute to regulatory documentation.
Preferred Qualifications
- Experience with long-acting injectables, ADC, biologics, oligonucleotides, advanced delivery systems.
- Knowledge of physico-chemical/biological properties and biopharmaceutics.
- Sterilization experience; container-closure integrity/primary packaging assessments.
- Technology transfer/scale-up; DOE and technical risk assessment.
- Regulatory submission experience; cGMP/regulatory requirements.
Location
- Hybrid role in the United States; on-site part of the week; some travel may be required.