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