What are the responsibilities and job description for the Bioanalytical Scientist position at BERG LLC?
POSITION SUMMARY:
The highly motivated bioanalytical scientist will support bioanalysis and biomarker development. The Bioanalytical Scientist will be responsible for developing novel assays and performing testing using complex and multiplexed assays.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- 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 programs.
- 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 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 BPGbio.
- Maintenance of laboratory equipment.
- Provide guidance to junior laboratory staff.
- Other duties, as assigned
REQUIREMENTS:
- Requires a BS with 10 years/M.S. with 4 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/PD studies and pre-clinical analysis of animal organs and biofluids via LC/MS/MS.
- Good interpersonal skills with an attention to detail and the ability 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.