Job Description:
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.
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:
We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue doing what is in the best interest of our patients.
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