Working as part of a small collaborative laboratory team, the successful candidate will be directly responsible for the operation of analytical instrumentation, including HPLC and LC-MS/MS and to provide strategic DMPK support to the discovery and nonclinical development of small molecule. The position will require the scientist to prepare samples, perform data acquisition and processing, data analysis and interpretation, as well as issue reports in accordance with regulatory, industry requirements. The scientist will also be required to participate in laboratory process improvement activities. The selected individual will be an integral project team member representing DMPK on small molecule and biologics research projects to ensure effective integration of ADME, PK and PKPD into the team strategy.
Roles and Responsibilities for the Position
- Development and validation of analytical (HPLC) and bioanalytical (LC-MS/MS) methods for the analysis of small molecules
- Preparation of standard operating procedures for the analysis of small molecules by LC-MS/MS and HPLC
- Perform potency, purity, impurity, stability study of small molecules to support structure–activity relationship (SAR) using HPLC
- Develop LC-MS/MS methods and perform bioanalysis for in vitro and in vivo biological samples in different animal models
- Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of drug candidates.
- Design and oversee DMPK studies (including in vitro metabolic stability, P450 inhibition, metabolite profiling, PAMPA)
- Perform PK data analysis and interpret results in relation to in vitro ADME data and PK data for compound analogues
- Oversee the analysis, interpretation, integration, and reporting of preclinical DMPK data generated both internally and with external vendors
- Routine maintenance and troubleshooting of LC-MS/MS and HPLC Instruments (Software and Hardware)
- Prepare documents to support regulatory IND filings
- Maintain accurate and timely electronic lab notebook
- Work effectively both independently and in a team environment
Required Qualifications and Background:
- B.S. in Chemistry with 7 years of relevant HPLC and LC-MS/MS experience, M.S. in Chemistry or life science with 5 years HPLC and LC-MS/MS experience, or Ph.D. in Chemistry/ Analytical Chemistry with >2 years of HPLC and LC-MS/MS experience
- 2+ year LC-MS/MS experience (Sciex systems preferred)
- Experience with analytical and bioanalysis method and assay development
- Strong knowledge of drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles.
- Proficient knowledge of ADME/DMPK assays and assessments used in drug discovery and drug development (e.g., in vitro stability, DDI, preclinical pharmacokinetics, and in vitro and in vivo correlations, etc.).
- Experience in PK and or PK/PD analysis using WinNonlin.
- Experience in serving on project teams in early discovery.
- Working knowledge of IND and regulatory submissions is helpful.
- Articulate, open communicator (both oral and written) with the ability to analyze, interpret and present data in a clear manner
- Analysis, interpretation, integration, and reporting of pharmacokinetic data and pharmacokinetic/pharmacodynamic (PK/PD) data to support discovery/preclinical projects.
- Strong problem solving and analysis skills
- Participate and contribute to discovery/preclinical development project teams
- Ability to independently review and summarize results.
- Clear communication of ADME/PK results at project team meetings and other meetings as needed
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