Ying Li
Principal Scientist, Cmc-analytical Development @Neurocrine Biosciences
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WORK HISTORY
Principal Scientist, Cmc-analytical Development @Neurocrine Biosciences
EDUCATION
Shanxi University
Bachelor of Science - BS, Bioengineering
UC Irvine
Master of Science - MS, Biotechnology (Emphasis in Stem Cell)
SKILLS
ABOUT YING LI
Bioassay Scientist with 10+ years of experience, specializing in GMP-compliant functional assay development for potency release methods, characterization methods, and HCP ELISAs.• Strong expertise in developing, qualifying, and/or validating methods from a variety of technologies, including cell-based potency assays, plate-based methods (ELISAs, Lumit platform), and associated instruments and software (PRISM, SoftMax Pro, PLA) to meet clinical phase-appropriate expectations. • Skilled in collaborating with internal teams and CDMOs to ensure seamless information and technical transfers, method validations, and assay troubleshooting.• Experienced in authoring GMP-compliant technical documentation with additional experience supporting an FDA pre-approval inspection.Key Skills:• Cell-based potency assay development• Mechanism of action (MoA) ELISA • HCP ELISA and impurity analysis• Method validation, optimization, and technology transfer• Fc effector function assay• ICH and USP guidelines • Regulatory filing (IND, INDa, IMPD, BLA support)• CDMO management and cross-functional collaboration
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