Principal Scientist (Mass Spectrometry)

Bausch Health Companies   •  

Rochester, NY

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 32 days ago

Overview

Manage and coordinate chromatography and mass spectrometry efforts for the Surgical Analytical and Material Science group with regards to new medical device product development and product investigations. Expert in mass spectrometry and chromatography of polymers.


Responsibilities

Serve as subject matter expert in area of expertise

Evaluate project needs with regard to physicochemical testing and biocompatibility requirements, develop test plans and make preliminary determination of scope of work. Coordinate chemical testing as an analytical chemistry representative on cross-functional project teams.

Responsible for conducting, developing and executing tests and experiments using both established methods and newly developed/novel techniques

Prepare written test strategies, protocols, schedule and perform tests, analyze test results, and prepare final reports

Communicate effectively with cross-functional project teams consisting of Commercial, Quality, Engineering, Regulatory team members and other disciplines regarding the status of all activities and align them to project deliverables.

Supervise, review and manage all chromatography work performed by the analytical group

This position is part of the R&D team with responsibility for product characterization for biocompatibility and product investigations.

Qualifications

Doctorate in Chemistry, Biochemistry or related discipline. Expertise in mass spectrometry and structural elucidation of unknowns.

  • 5+ years of Mass Spectrometry experience
  • Medical device experience and familiarity with ISO 10993-1 a plus.
  • Extractables and leachables testing via LC-MS and method development experience highly desired.
  • Experience with trace level analysis.
  • Profile analytes within stability studies.
  • Knowledge of polymer chemistry.
  • Familiarity with working under GMP/GLP regulations.
  • Experience in validations/method development.
  • Experience with controlled extraction studies.
  • Leadership experience