Senior Scientist - Biologics

About the role

The Senior Scientist Biologics will lead and support the development and characterization of biologics, ensuring that assays meet phase-appropriate standards. They will also oversee microbiological testing strategies and provide scientific direction and interpretation of data.

Responsibilities

• Technical Lead and Subject Matter Expert (SME) for de novo method development and characterization based on protein structure and biochemistry
• Strategic and scientific direction for phase-appropriate, biologics-specific assays
• Oversee microbiological testing strategy, including compendial method verification (endotoxin, bioburden, sterility)
• Critically review and approve bioassay protocols
• Provide scientific review of protocols, reports, and methods
• 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

Requirements

• Bachelor's degree in biochemistry with at least 5+ years of directly relevant professional experience in protein structure and functional assays
• Demonstrated organizational leadership skills at functional levels
• Application of sound and accurate judgment to make timely decisions
• Excellent strategic acumen, collaboration, and communication skills
• Excellent interpersonal, verbal, and written communication skills

Qualifications

• Ability to travel in the U.S. and internationally, as needed, for contract manufacturing oversight and Civica manufacturing site
• Travel of up to 10% may be required