Overview
The Scientist will be part of the Analytical Development Starting Material Group and will be responsible for developing, qualifying, and transferring analytical methods for starting materials, raw materials, intermediates, and excipients to suppliers, CMOs, and QC laboratories.

Key Responsibilities

• Develop, qualify, and transfer GC, HPLC, UPLC, and mass spectrometry-based assays for starting materials, raw materials, intermediates, and excipients.
• Identify impurity profiles and provide data to establish impurity limits.
• Apply advanced scientific principles, theories, concepts, practices, and standards to process and analytical development.
• Author and review method development and qualification reports, SOPs for test methods, and transfer/qualification protocols and reports related to critical starting materials, intermediates, and excipients.
• Provide analytical support to both external and internal teams.

Qualifications

• Ph.D. in Analytical Chemistry or related discipline with over 1 year of biopharmaceutical experience, or equivalent.
• Master’s degree with over 5 years of biopharmaceutical experience, demonstrating expertise in chromatographic separation, method development/qualification, and structure elucidation.
• Strong knowledge of fundamental chromatographic separation mechanisms in both gas and liquid phases, with proven hands-on method development and optimization experience on HPLC, UPLC, and GC for molecule and isomer separation.
• Solid background in organic chemistry, focusing 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. Experience with Empower, MassLynx, MassHunter, and XCalibur CDS is preferred.