Principal Scientist
GSK
August 25, 2026
Remote friendly (Collegeville, PA)
United States
Clinical Research and Development
Position Summary:
Scientist in sterile drug product development focused on leading biopharmaceutical protein (e.g., mAbs, bispecific mAbs, ADCs) and peptide therapeutics drug product development for Clinical Phases 2–3 and commercialization.
Role Responsibilities:
- Matrix leadership and cross-department collaboration to progress drug product development.
- Laboratory experimentation using biophysical techniques.
- Conduct non-GMP protein formulation optimization and development stability studies.
- Perform in-use compatibility/stability assessments to support product administration.
- Support drug product process development, characterization, and technical transfer to GMP manufacturing.
- Author technical and regulatory documents; maintain accurate, complete electronic laboratory records.
- Use electronic data/information gathering, capture, archiving, and communications.
- Potential contribution to small-molecule drug product development (e.g., chemical entities, oligonucleotides).
Basic Qualifications (Required):
- PhD in Pharmaceutical Sciences/Chemistry/Biochemistry/Biology/Bioengineering/Biomedical/ Chemical Engineering with 0+ years protein formulation and/or process development; or MS with 5+ years industry experience; or BS with 7+ years industry experience.
- Experience authoring technical documents.
Preferred Qualifications:
- ADC experience.
- Bioanalytical interpretation for characterization and stability.
- Conventional/alternative protein formulation stability evaluation using DOE/statistical experimental design.
- Protein drug product process development (e.g., vial/PFS solution, lyophilization), container/closure and drug-delivery feasibility/compatibility.
- Biophysical characterization/stability (e.g., DSC, DSF/Uncle/Prometheus Panta, particle sizing, light scattering).
- Regulatory document authoring and critical review (IND/IMPD, BLA/MAA), especially late clinical phase; regulatory Q&A.
- Manufacturing technology transfer to commercial and/or scale-up.
- Experience with biopharm combination products.
- Strong independent and team/matrix communication; accurate lab records and electronic data management.
Scientist in sterile drug product development focused on leading biopharmaceutical protein (e.g., mAbs, bispecific mAbs, ADCs) and peptide therapeutics drug product development for Clinical Phases 2–3 and commercialization.
Role Responsibilities:
- Matrix leadership and cross-department collaboration to progress drug product development.
- Laboratory experimentation using biophysical techniques.
- Conduct non-GMP protein formulation optimization and development stability studies.
- Perform in-use compatibility/stability assessments to support product administration.
- Support drug product process development, characterization, and technical transfer to GMP manufacturing.
- Author technical and regulatory documents; maintain accurate, complete electronic laboratory records.
- Use electronic data/information gathering, capture, archiving, and communications.
- Potential contribution to small-molecule drug product development (e.g., chemical entities, oligonucleotides).
Basic Qualifications (Required):
- PhD in Pharmaceutical Sciences/Chemistry/Biochemistry/Biology/Bioengineering/Biomedical/ Chemical Engineering with 0+ years protein formulation and/or process development; or MS with 5+ years industry experience; or BS with 7+ years industry experience.
- Experience authoring technical documents.
Preferred Qualifications:
- ADC experience.
- Bioanalytical interpretation for characterization and stability.
- Conventional/alternative protein formulation stability evaluation using DOE/statistical experimental design.
- Protein drug product process development (e.g., vial/PFS solution, lyophilization), container/closure and drug-delivery feasibility/compatibility.
- Biophysical characterization/stability (e.g., DSC, DSF/Uncle/Prometheus Panta, particle sizing, light scattering).
- Regulatory document authoring and critical review (IND/IMPD, BLA/MAA), especially late clinical phase; regulatory Q&A.
- Manufacturing technology transfer to commercial and/or scale-up.
- Experience with biopharm combination products.
- Strong independent and team/matrix communication; accurate lab records and electronic data management.