Manager Bioanalytical

About the role

This role involves designing, optimizing, and validating analytical methods for oligonucleotides and metabolites, as well as ligand-binding assays for large molecules. Responsibilities also include overseeing the life cycle of bioanalytical assays and ensuring compliance with global regulatory guidelines.

Responsibilities

• Design, optimize, and validate analytical methods for ONTs and metabolites (e.g., LC-MS/MS, hybrid-ELISA, qPCR)
• 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
• 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 comply with global regulatory guidelines and support IND and NDA filings

Requirements

• 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
• 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

Skills

• DMPK
• Immunogenicity
• PK assay
• Translational biology
• Assay development
• siRNA
• Conjugated ONTs
• Tissue
• LCMS
• ELIs
• qPCR
• Ligand binding assays
• Elisa
• CRO
• In vitro
• In vivo
• ADME
• IND filing

Top Skills

• DMPK
• Immunogenicity
• PK assay
• Translational biology
• Assay development
• siRNA
• Conjugated ONTs
• Tissue
• LCMS
• ELIs
• qPCR

Additional Skills & Qualifications

• 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
• 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