Senior Scientist - Biologics

Civica Rx • Petersburg, VA

13h • Remote

About The Position

Our Biologics Development team brings essential biosimilar medicines to our patients in the United States by providing analytical expertise in developing protein bioassays, interpreting data, and assuring a thorough analytical package for health authority review. The Senior Scientist will bring their knowledge and experience in service to patients and pursuit of excellence to secure low cost insulins to patients within the United States.

Requirements

• 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

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior