Senior Scientist - Biologics

About the role

The Senior Scientist Biologics will lead the development and characterization of protein bioassays, oversee microbiological testing strategies, and provide scientific direction and interpretation of data to support health authority review. They will also act as a subject matter expert in regulatory interactions and defend bioassay and biological methods based on Protein Chemistry.

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)
• Critically review and approve bioassay protocols
• Author specialized, preformatted, facility sections to create a facility core dossier
• Lead and conduct activities or projects as assigned

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

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

Skills

• Proven experience in protein structure and functional assays
• Strong leadership and project management skills
• Excellent communication and collaboration abilities

Benefits

• Flexible remote work style
• Opportunity to work on innovative solutions for patient care
• Competitive compensation package
• Health, dental, and vision insurance
• 401(k) retirement plan

Pay

Compensation is commensurate with experience.

Schedule

The role offers a flexible remote work style with travel to Civica’s Petersburg, Virginia manufacturing facility and Lehi, Utah office as needed.

Contact

To apply, please visit Civica Rx's website.

Location

1 Civica Way
Petersburg, VA 23805
United States