JOBSEARCHER

Senior Manager Bioanalytical Development

We’re looking for a highly skilled Bioanalytical Scientist to join an innovative team focused on advancing oligonucleotide therapeutics (ONTs). This is a critical role supporting both clinical and nonclinical development programs, with strong visibility across cross-functional teams.🔬 What You’ll Do:• Lead development, optimization, and validation of bioanalytical assays (LC-MS/MS, qPCR, ELISA, MSD)• Drive PK and immunogenicity (ADA/NAb) assay strategies• Manage assay lifecycle from early development through regulatory submission• Oversee CROs for method development, sample analysis, and data quality• Analyze and interpret PK/PD and immunogenicity data to support decision-making• Contribute to IND/NDA filings and ensure compliance with GLP/GCP and ICH guidelines🧬 What We’re Looking For:• PhD in Analytical Chemistry, Biochemistry, or related field• 3–5+ years of experience in bioanalytical method development• Strong expertise in oligonucleotide therapeutics (siRNA, ASOs, ONTs)• Hands-on experience with LC-MS/MS, ligand-binding assays, and qPCR• Deep understanding of DMPK, PK/PD, and immunogenicity• Experience managing CROs and working in cross-functional teams• Familiarity with regulatory standards (GLP/GCP, ICH M10)