Scientific Responsibilities
- Design, execute, and interpret a range of in vitro ADME/DMPK studies, including:
- Metabolic stability
- Reaction phenotyping
- Metabolite identification
- CYP inhibition and induction
- Transporter studies
- Plasma protein binding
- Solubility and permeability assays
- Analyze and interpret complex scientific datasets.
- Prepare study reports, data summaries, and client presentations.
- Troubleshoot technical challenges and recommend scientifically sound solutions.
- Contribute to assay development, validation, and continuous improvement initiatives.
- Ensure studies are conducted in accordance with client requirements and applicable quality standards.
Client and Project Responsibilities
- Serve as a scientific point of contact for assigned client programs.
- Participate in project kickoff meetings, study updates, and scientific discussions with clients.
- Provide technical input during proposal development and study scoping activities.
- Support Business Development teams by participating in scientific and capabilities presentations.
- Build strong client relationships through scientific excellence and responsive communication.
Quality and Compliance
- Maintain accurate laboratory records and documentation.
- Ensure compliance with GLP, GCP, GMP, and internal quality systems as applicable.
- Support client audits, regulatory inspections, and quality investigations.
- Promote a culture of scientific integrity, quality, and continuous improvement.
Success Measures
- Deliver high-quality, scientifically robust ADME data on time.
- Build strong relationships with clients and internal stakeholders.
- Contribute to repeat business through technical expertise and exceptional customer service.
- Support growth of the ADME business through innovation, scientific leadership, and operational excellence.
Required
- M.S. with 3+ years of relevant industry experience; Pharmaceutical Sciences, Drug Metabolism, Biochemistry, Chemistry, or related field with 0-3 years of relevant experience; or
- B.S. with 5+ years of relevant industry experience.
- Experience conducting in vitro ADME or DMPK studies.
- Experience within a Contract Research Organization (CRO) environment.
- Strong understanding of drug metabolism, pharmacokinetics, and drug-drug interaction assessment.
- Experience with LC-MS/MS data interpretation.
- Excellent verbal and written communication skills.
- Demonstrated ability to manage multiple projects simultaneously.
Preferred
- Experience in metabolite identification (MetID).
- Knowledge of regulatory guidance related to DMPK studies.
- Experience supporting pharmaceutical and biotechnology clients.
- Familiarity with software such as MassHunter, Analyst, Phoenix WinNonlin, MetabolitePilot, or equivalent.
- Previous client-facing experience.
- Experience contributing to business development activities or proposal generation.
