OverviewThe Biotransformation group within Drug Metabolism and Bioanalysis (DMB) supports discovery and development programs through characterization of drug metabolism and disposition.
We are seeking an experienced scientist who has the flexibility to provide hands-on (lab-based) support of biotransformation (metabolite identification) activities across a portfolio of small molecule programs. The incumbent will contribute to metabolite identification and data interpretation for compounds during optimization and development, while scientifically and strategically interfacing with other DMPK colleagues as well as Medicinal Chemistry partners.
Essential Functions of the Job (Key responsibilities)
- Conduct in vitro and in vivo biotransformation studies, including hepatocyte, microsomal, and radiolabeled (e.g., 14C) ADME investigations
- Perform metabolite identification using LC-MS/MS and high-resolution mass spectrometry platforms (e.g., Orbitrap, QTOF)
- Analyze and interpret mass spectrometry data to characterize metabolic pathways and identify potential liabilities
- Serve as the biotransformation representative on assigned discovery program(s), with level of independence commensurate with experience
- Generate and communicate metabolite identification results to support medicinal chemistry and program decision-making
- Support development programs through analysis and reporting of preclinical and clinical ADME studies, including mass balance and human ADME studies
- Prepare and review technical reports and contribute to regulatory documents (IND/NDA) as appropriate
- Collaborate with cross-functional teams and coordinate external CRO activities as needed
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Ph.D. in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related discipline with 0-5+ years of relevant industry or postdoctoral experience
or - M.S. with 4-8+ years of relevant industry experience
or - B.S. with 6-10+ years of relevant industry experience
- Experience in biotransformation and metabolite identification in a pharmaceutical or CRO environment
- Hands-on experience with in vitro metabolism systems (e.g., hepatocytes, microsomes)
- Experience interpreting LC-MS/MS or high-resolution MS data for metabolite identification
- Experience working with or supporting radiolabeled (e.g., 14C) ADME studies, including sample handling, data generation, or interpretation
- Strong understanding of drug metabolism pathways (e.g., CYP, UGT)
- Ability to analyze complex data and clearly communicate findings to matrix team members
Preferred Qualifications- Experience contributing to regulatory submissions (IND/NDA)
- Familiarity with metabolite identification software (e.g., UNIFI, Compound Discoverer, MassMetaSite)
- Experience working in a cross-functional drug discovery environment
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
