Scientist – Analytical Development

Responsibilities:

• Develop, qualify and transfer 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 SOP’s for test methods, as well as transfer / qualification protocols and reports related to critical starting materials / intermediates / excipients.
• Provide analytical support externally and internally.

Qualifications:

• Ph.D. in Analytical Chemistry or related disciplines with > 1 year biopharmaceutical experience or equivalent.
• Master 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 Spectrometery hardware. Familiarity with Empower, Masslynx, Masshunter, and XCalibur CDS are preferred.