Senior Manager, Bioanalytical Development

Start Date: ASAP

Duration: 12 months + chance to extend

Hours/week: 40 hours/week

• Oligonucleotide (siRNA preferred) PK bioanalytical development experience in nonclinical, ADME/DMPK (e.g., met , quantification) to clinical studies
• LC-MS/MS, hybridization assays with hands on assay development and validation experience
• GLP and GCP compliance experience in lab, CRO management and regulatory submissions
• Immunogenicity and biomarker development.
• 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

The department of Quantitative & Clinical Pharmacology (QCP) at Client is seeking applicants for a Senior Scientist of Bioanalytical Development in DMPK and Immunogenicity. This role will lead the development, validation and execution of PK and ADA assays in clinical and nonclinical studies to enable lead optimization, clinical candidate selection, pharmacology evaluations on safety and efficacy and contribute to regulatory filings.

The incumbent will serve as a functional area representative and partner closely with QCP, Translational Biology, Clinical Operations, Nonclinical Development and Operations. A successful candidate must have demonstrated success in assay development and validation, clinical and nonclinical study support, regulatory compliant data analysis/reporting and CRO management. Experience in oligonucleotides therapeutics (ONTs) including siRNA, ASOs, conjugated ONTs, as well as complex biological matrices (CSF, tissues) is a must.

• 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
• 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