Principal Scientist

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. #J-18808-Ljbffr Scorpion Therapeutics