Bioanalytical Scientist


Full time

Framingham, MA

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.

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 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

Qualifications

  • 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.

BERG in the News!

BERG is making headlines.  Click here to see the latest breaking news, interviews, and press releases.