Contract, Senior Manager, Bioanalytical Development (DMPK, Bioanalysis

Job Title

Position is Remote to Hybrid in the Greater Boston Area

• 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
• Oversee life cycle management of bioanalytical assays from early-stage development through registration and across evolving program objectives
• Serve as the primary contact for CROs, managing technical oversight of method development, assay transfers, sample analysis, troubleshooting and auditing to ensure high data standards and quality
• Provide SME and technical expertise on nonclinical and clinical study teams, contributing to study protocol development, lab manuals, sample management and bioanalytical data reporting
• 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

• Ph.D. in Medicinal Chemistry, Analytical Chemistry, Biochemistry, or related field and 3 to 5 years of Analytical and/or Bioanalytical Chemistry laboratory experience including study and CRO management
• Proven success and hands-on experience in the development of oligonucleotide bioanalytical methods and sample extraction techniques for tissue and fluid-based matrices
• Strong understanding of oligonucleotide chemistry, conjugation and linker platforms
• Demonstrates inter-disciplinary knowledge of drug discovery and development (in vitro/in vivo pharmacology, ADME, PK/PD, translational and clinical research)
• Proficiency in GLP/GCP-compliant laboratory regulations, ICH guidelines and procedures
• Strong written and verbal communication skills for data reporting, interpretation and presentation, and cross-functional team collaboration