Description

• Design and execute bioanalytical studies to support PK, PD, TK, biomarker, and biodistribution assessments using LC-MS/MS, ELISA/MSD, qPCR/ddPCR, and cell-based assays.
• Independently develop, optimize, and validate LC-MS methods for qualitative and quantitative analysis of small molecules, oligonucleotides, biologics, and novel modalities.
• Conduct in vitro and in vivo DMPK studies, including dosing, sample collection (e.g., blood, plasma, tissues), and data interpretation.
• Support ADME assay development (e.g., metabolic stability, plasma protein binding, DDI, permeability).
• Maintain and troubleshoot lab instrumentation (LC-MS, HPLC, plate readers, thermocyclers).
• Analyze and interpret data, troubleshoot issues, and ensure data quality and integrity.
• Accurately document protocols and results in lab notebooks; contribute to formal reports and regulatory submissions.
• Mentor junior team members and collaborate with project leads to ensure timely study execution.
• Stay current with advances in DMPK and bioanalytical methods; apply new knowledge to project designs.
• Participate in team meetings and present scientific findings to internal stakeholders and clients.

Requirements

• M.S. or Ph.D. in Pharmacology, Biochemistry, Analytical Chemistry, or related field
• 3+ years of industry or CRO experience in DMPK, bioanalysis, or preclinical research
• Hands-on experience in LC-MS/MS method development, sample prep, and quantitative analysis of small molecules, oligonucleotides, biologics, and CGT products
• Familiarity with in vitro ADME and in vivo PK studies, including animal dosing and biological sample handling
• Proficiency in data analysis software (e.g., Analyst®, WinNonlin®, GraphPad Prism)
• Strong documentation practices with working knowledge of GLP/GxP standards
• Excellent teamwork, communication, and time management skills