This position is in the Bioanalytical Laboratory within the Precision Medicine group at BERG. He/she will develop and validate bioanalytical assays in a GCLP setting using CLIA guidance. As a bioanalytical scientist, he/she is will be responsible for maintaining bioanalysis workflows using mass spectrometry-based assays, working with quality assurance, and integrating with a multidisciplinary omics team to advance research programs. The candidate will also be part of the development of innovative assays for compound screening.
- Develop and validate LC-MS/MS methods in support of pre-clinical and clinical programs.
- Develop and qualify LC-MS/MS methods for the quantification of peptides and small molecules from biological matrices including plasma, serum, and tissues.
- Develop and validate LC-MS/MS methods for endogenous molecules for the clinical diagnostic efforts.
- Draft and approve validation documents and test reports for clinical and pre-clinical studies in accordance with FDA Bioanalytical Method Validation guidelines.
- Draft and approve clinical diagnostic protocols and test methods in accordance with GCLP and/or CLIA regulations.
- Perform maintenance and troubleshoot instrument-related problems on AB Sciex 5500 and 6500 QTrap, AB Sciex 5500 LC/MS, Agilent LC/MS, Agilent 1200, and Shimadzu HPLC on a routine basis.
- Work closely with the research groups at BERG.
- Maintenance of laboratory equipment.
- Provide guidance to junior laboratory staff.
- Other duties, as assigned
- Requires a B.S. with 5+ years/M.S. with 3 years/Ph.D. with 2+ years of experience in LC/MS/MS method development for small molecule quantitation and bioanalytical method validation in a regulated environment.
- Experience in PK studies and pre-clinical analysis of animal organs and biofluids via LC/MS/MS.
- Good interpersonal skills, have attention to detail and be able to work well independently as well as in a team
- Capable of working in a flexible and dynamically changing work environment with tight timelines.
- Possess good written and oral communication skills.
- Willing to work in a dynamic, fast-paced environment and adapt to challenges offered in a growing company.