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Senior Scientist/Scientist, Analytical Chemistry

Job Description

Located at our center of excellence in Canton, Massachusetts, the Senior Scientist/Scientist position will join the analytical chemistry team supporting QC, CMC, and E/L chromatographic and mass spectrometric (MS) analyses. This position is a team member in the Small Molecule Services (SMS) in a Good Manufacturing Practices (GMP) laboratory environment.

Critical Performance Areas

  • Perform quality lab activities according to assigned schedule
  • Process samples for testing, including complex sample preparation, according to GMP requirements
  • Document experiments, sample tracking, and raw data according to Standard Operating Procedures (SOPs) and GMP requirements
  • Generate, interpret/review data, write/review analytical reports
  • Develop, validate, and/or transfer analytical methods for the analysis of drugs according to GMP requirements
  • Handle multiple projects at the same time and ensure on-time testing and delivery of analytical results to clients

Essential Job Functions

  • Ensure compliance with GMP regulatory requirements and SOPs
  • Collaborate with scientists and/or lead team to investigate under GMP for deviation, non-conformity, Out of Specifications (OOS), change controls, and other quality events
  • Train peers in the team as needed
  • Contribute to process improvements for effective and efficient workflows in the lab
  • Maintain inventory, ordering of laboratory supplies, and instrument maintenance and troubleshooting
  • Maintain inventory, ordering of laboratory supplies, and instrument maintenance and troubleshooting

Requirements

  • MS in Analytical Chemistry or related discipline with 5+ years relevant experience, or PhD in Analytical Chemistry or related discipline with 2+ years relevant experience
  • Experience working in GMP or GLP environment
  • Experience in method development and method validation using the following equipment or techniques is required:
    • HPLC (UV or DAD, MS, MS/MS)
    • GC (FID, MS, MS/MS)

Other Desired Skills/Abilities

  • Excellent organizational skills and ability to work independently
  • Strong written and verbal communication skills
  • Functional understanding of relevant regulatory or industry guidance
  • Ability to demonstrate expertise in LC/MS and/or high-resolution accurate mass (HRAM) analysis is preferred
  • Customer-facing experience is preferred
  • Relevant experience operating ThermoFisher or Agilent instrumentation
  • Expertise in use of at least one of the following software applications:
    • Chemstation (OpenLab)
    • Mass Hunter
    • Chromeleon
    • Compound Discoverer

This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

Disclaimer: Solvias US does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.

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