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.