Scientist, Analytical Development

About the role

The Scientist, part of the Analytical Development Starting Material Group, will 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. Responsibilities include identifying impurity profiles and providing data to set impurity limits, as well as applying advanced scientific principles to process and analytical development.

Responsibilities

• Develop, qualify, and transfer chromatographic and mass spectrometry-based assays for starting materials, raw materials, intermediates, and excipients.
• Identify impurity profiles and provide data to establish impurity limits.
• Author and review method development and qualification reports, SOPs for test methods, and transfer/qualification protocols and reports related to critical materials.
• Provide analytical support both externally and internally.

Qualifications

• Ph.D. in Analytical Chemistry, Organic Chemistry, or related discipline with >1 year of biopharmaceutical experience, or a Master’s degree with >5 years of biopharmaceutical experience.
• Demonstrated expertise in chromatographic separation, method development/qualification, and structure elucidation.
• Strong knowledge of chromatographic separation mechanisms in gas and liquid phases, with hands-on experience in HPLC, UPLC, and GC method development and optimization.
• Sound background in organic chemistry, focusing on structure characterization and elucidation using 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.
• Experience in peptide and/or oligonucleotide analysis is a plus.

Pay

Pay ranges between $40–$47 per hour based on experience.