Clinical Lab Scientist

Clinical/Development – Scientist, Analytical Development

Cambridge MA

50-52 per hour

Top skills: chromatographic separation mechanisms in both gas and liquid phases, structure elucidation expertise, and MS experience.

• Ph.D. in Analytical Chemistry, Organic Chemistry, or related disciplines with more than 1 year of biopharmaceutical experience, or equivalent.
• Master’s degree with more than 5 years of biopharmaceutical experience, with demonstrated chromatographic separation, method development/qualification, and structure elucidation expertise.
• You must have either a Ph.D. with 1 year of experience or a Master’s degree with 5 years of experience.

The Scientist is part of the Analytical Development Starting Material Group and will be responsible for:

• Developing, qualifying, and transferring GC, HPLC, UPLC, and mass spectrometry–based assays of starting materials, raw materials, intermediates, and excipients to suppliers, CMOs, and QC.
• Identifying impurity profiles and providing data to set impurity limits.
• Understanding and applying advanced scientific principles, theories, concepts, practices, and standards to process and analytical development.
• Authoring and reviewing method development and qualification reports and SOPs for test methods, as well as transfer/qualification protocols and reports related to critical starting materials, intermediates, and excipients.
• Providing analytical support externally and internally.
• Strong knowledge of fundamental chromatographic separation mechanisms in both gas and liquid phases, with proven years of excellent hands‑on method development and optimization experience using HPLC, UPLC, and GC for separation of molecules and isomers.
• Sound background in organic chemistry with a focus on structure characterization and elucidation of synthetic molecules through determination and interpretation of mass spectrometry and NMR data.
• Self‑motivated with excellent communication, writing, and reviewing skills.
• Familiarity with Waters and Agilent (U)
  HPLC and mass spectrometry hardware.
• Familiarity with Empower, Mass Lynx, Mass Hunter, and XCalibur CDS is preferred.