Position Overview
Bioanalytical Scientist (DMPK / Immunogenicity)
Overview:
We are seeking a highly skilled Bioanalytical Scientist to lead the development, validation, and lifecycle management of analytical methods supporting drug development programs. This role will focus on oligonucleotide therapeutics and large molecule bioanalysis, supporting both nonclinical and clinical studies in a regulated environment.
Key Responsibilities:
+ Design, optimize, and validate high-sensitivity analytical methods (e.g., LC-MS/MS, hybrid ELISA, qPCR) for oligonucleotide therapeutics (ONTs) and their metabolites
+ Develop and validate ligand-binding assays (e.g., ELISA, MSD/ECL) to support pharmacokinetics (PK) and immunogenicity assessments (ADA, NAb) for large molecules
+ Oversee the full lifecycle of bioanalytical assays, from early development through clinical phases and regulatory submission
+ Analyze, interpret, and report complex bioanalytical data, including PK and...