Note: The job is a remote job and is open to candidates in USA. GForce Life Sciences is seeking a Scientist Consultant III in Biologics Analytical Development. The role involves leading the development and optimization of analytical assays, supporting regulatory submissions, and collaborating with partners on method qualification and validation.
Responsibilities
- 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
Skills
- 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
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