Opportunity Description
Description
Design, optimize, and validate robust, high-sensitivity analytical methods (e.g., LC-MS/MS, hybrid-ELISA, and qPCR) for ONTs and metabolites Design, optimize, and validate ligand-binding assays (e.g., ELISA, MSD ECL) for large molecule PK and immunogenicity (ADA, NAb) Oversee life cycle management of bioanalytical assays from early-stage development through registration and across evolving program objectives Analyze, interpret and report complex data (PK and immunogenicity) to support in vitro/in vivo ADME, DMPK, TK, and PK/PD data evaluations across nonclinical and clinical development Ensure all bioanalytical activities are compliant with global regulatory guidelines and ICH M10 requirements, and support IND and NDA filings
Skills
DMPK, Immunogenicity, PK assay, Translational biology, assay development, siRNA, conjugated ONTs, tissue, LCMS, ELIs, qPCR, ligand binding assays, Elisa, CRO, in vitro, in vivo, ADME, IND filing
Top Skills Detai...
Design, optimize, and validate robust, high-sensitivity analytical methods (e.g., LC-MS/MS, hybrid-ELISA, and qPCR) for ONTs and metabolites Design, optimize, and validate ligand-binding assays (e.g., ELISA, MSD ECL) for large molecule PK and immunogenicity (ADA, NAb) Oversee life cycle management of bioanalytical assays from early-stage development through registration and across evolving program objectives Analyze, interpret and report complex data (PK and immunogenicity) to support in vitro/in vivo ADME, DMPK, TK, and PK/PD data evaluations across nonclinical and clinical development Ensure all bioanalytical activities are compliant with global regulatory guidelines and ICH M10 requirements, and support IND and NDA filings
Skills
DMPK, Immunogenicity, PK assay, Translational biology, assay development, siRNA, conjugated ONTs, tissue, LCMS, ELIs, qPCR, ligand binding assays, Elisa, CRO, in vitro, in vivo, ADME, IND filing
Top Skills Detai...
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