Senior Scientist Bioanalytical Development
We are seeking a Senior Scientist to lead bioanalytical assay development supporting DMPK and immunogenicity for oligonucleotide therapeutics. This role plays a key part in advancing drug candidates from early research through clinical development and regulatory submission.Key Responsibilities:PhD in Analytical Chemistry, Biochemistry, or related field3–5 years of bioanalytical/analytical lab experienceStrong expertise in oligonucleotide bioanalysis and complex biological matricesExperience with GLP/GCP, regulatory guidelines, and CRO managementNeed expereince in LC‑MS work did you personally run? Need describe a bioanalytical assay you developed or validated yourself from start to finish? LC‑MS work directly support an IND, GLP, or GCP study? If yes, how?Develop, optimize, and validate PK and ADA assays (LC-MS/MS, ELISA, qPCR)Lead bioanalytical strategies for oligonucleotides (siRNA, ASO, conjugates)Manage CROs for assay development, transfer, and sample analysisAnalyze and interpret PK, ADA, and PK/PD data for nonclinical and clinical studiesSupport study design, regulatory submissions (IND/NDA), and ensure ICH M10 complianceCollaborate cross-functionally with clinical, translational, and nonclinical teams