The Senior Scientist Biologics will:

•                    Technical Lead and SME for de novo method development and characterization based on protein structure and biochemistry Provide strategic and scientific direction for phase-appropriate, biologics-specific assays Oversee microbiological testing strategy, including compendial method verification (endotoxin, bioburden, sterility), and ensures methods are suitable for the product

•                    Critically review and approve bioassay protocols; provide scientific direction and interpretation of data to drive next steps

•                    Provide scientific review of protocols, reports, and methods; establish clear technical expectations and guidance documents.

•                    Author specialized, preformatted, facility sections to create a facility core dossier

•                    Act as SME in regulatory interactions, including FDA meetings and inspections; defend bioassay and biological methods, based on Protein Chemistry

•                    Lead and conduct activities or projects as assigned