Job Description:
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
This role offers a flexible remote work style with travel to Civica's Petersburg, Virginia manufacturing facility and Lehi, Utah office as needed.
Basic Qualifications and Capabilities:
What we look for:
• A Bachelors 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 are required
• Excellent interpersonal, verbal, and written communication skills
Physical Demands and Work Environment:
• 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
