Analytical Development Scientist

Clinical/Development - Scientist, Analytical Development

Cambridge MA

50-52 per hour

Long Term contract

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

Qualifications

• 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.

Job Summary

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, MassLynx, MassHunter, and XCalibur CDS is preferred.

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