- Location: NJ, United States
- Type: Contract
- Job ID: 10346
- Work Setting: On-Site
- Posted: May 26, 2026
- Closing Date: May 31, 2027
- Tax Status: W2
Scientist Consultant III – Biologics Analytical Development
12-month Contract
Remote- EST hours Preferred
Requirements
12-month Contract
Remote- EST hours Preferred
Requirements
- Lead and execute development, optimization, and troubleshooting of critical analytical assays (e.g., purity, potency, and characterization).
- Support product and process characterization and comparability assessments.
- Author and review analytical development reports and CMC documentation for regulatory submissions.
- Support analytical method qualification/validation and transfer activities in collaboration with internal and external partners.
- Provide technical expertise and support analytical development activities.
- Bachelor’s degree in Biochemistry, Molecular Biology, or similar scientific field with 8 years of industry experience; OR
- Master’s degree in Biochemistry, Molecular Biology, or similar scientific field with 6 years of industry experience; OR
- Ph.D. in Biochemistry, Molecular Biology, or similar scientific field with 4 years of industry experience.
- Expertise in microbiology assays for biologics, including bioburden, endotoxin, and sterility testing.
- Basic understanding of other common biologics analytical techniques.
- Experience working with CDMOs and CROs, including method transfers and method development.
- Experience overseeing multiple concurrent studies across distinct laboratories.
- Working knowledge of method validation principles.
- Experience with U.S. and international BLA filings and reviews.
- Solid understanding of monoclonal antibodies (mAbs) and other biologics, their attributes, and appropriate analytical testing.
- Ability to communicate complex analytical methods to non-expert audiences.