Clinical Scientist

Scientist – Analytical Development (Clinical/Development)
Job Summary

The Scientist will join the Analytical Development Starting Material Group and provide expertise in developing, qualifying, and transferring analytical methods for starting materials, raw materials, intermediates, and excipients. This role supports both internal teams and external partners, including suppliers, CMOs, and QC laboratories.

Key responsibilities include method development, impurity profiling, structure elucidation, and authoring technical documentation. The position requires strong chromatographic and mass spectrometry skills, along with a deep understanding of analytical and organic chemistry principles.

• Develop, qualify, and transfer GC, HPLC, UPLC, and mass spectrometry–based assays for starting materials, raw materials, intermediates, and excipients
• Identify impurity profiles and generate data to support impurity limit setting
• Apply advanced scientific principles, theories, and practices to analytical and process development
• Author and review method development reports, qualification reports, SOPs, and transfer/qualification protocols
• Provide analytical support to internal teams and external partners (suppliers, CMOs, QC)

• Ph.D. in Analytical Chemistry, Organic Chemistry, or related discipline with 1+ year of biopharmaceutical experience OR
• Master’s degree with 5+ years of biopharmaceutical experience, including demonstrated expertise in chromatographic separation, method development/qualification, and structure elucidation

• Strong understanding of chromatographic separation mechanisms in both gas and liquid phases
• Extensive hands‑on experience developing and optimizing HPLC, UPLC, and GC methods for molecular and isomer separation
• Solid background in organic chemistry with expertise in structure characterization and elucidation using mass spectrometry and NMR
• Familiarity with Waters and Agilent (U)
  HPLC and mass spectrometry hardware
• Experience with Empower, Mass Lynx, Mass Hunter, and XCalibur CDS preferred

• Strong communication, technical writing, and document review abilities
• Self‑motivated with the ability to work independently and collaboratively

• Ph.D. + 1 year experience or Master’s + 5 years experience
• Gas and liquid phase chromatographic separation