Scientist, Analytical Development

Overview

Job Title:

Scientist, Analytical Development

Location:

Cambridge, MA

Duration: 09 Months+

• The Scientist is part of 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.
• Identify impurity profiles and provide data to set impurity limits.
• Understand and apply advanced scientific principles, theories, concepts, practices and standards to process and analytical development.
• Author and review method development and qualification reports and SOPs for test methods, as well as transfer / qualification protocols and reports related to critical starting materials / intermediates / excipients.
• Provide analytical support externally and internally.

• Ph.D. in Analytical Chemistry, Organic Chemistry or related disciplines with > 1 year biopharmaceutical experience or equivalent.
• Master's degree with > 5 years biopharmaceutical experience respectively, with demonstrated chromatographic separation, method development / qualification and structure elucidation expertise.
• Strong knowledge of fundamental chromatographic separation mechanisms in both gas phase and liquid phase, proven years of excellent hands-on method development and optimization experience on 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, 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 are preferred.
• Must have either a PhD with 1 year of exp or master's with 5 years of exp.

• Chromatographic separation mechanisms in both gas phase and liquid phase and structure elucidation expertise, and MS experience.