Scientist, Analytical Development

Overview

• Contribute to analytical development processes for starting materials, intermediates, and excipients in a contract-based role.
• Develop and qualify GC, HPLC, UPLC, and mass spectrometry assays for material analysis.
• Collaborate with suppliers, CMOs, and QC teams for method transfer and qualification.
• Identify impurity profiles and establish impurity limits based on analytical data.
• Apply advanced scientific principles to process and analytical development projects.
• Author and review technical documents including SOPs, protocols, and reports.
• Provide analytical support to internal and external stakeholders.
• Engage in chromatographic separation and method development for molecule analysis.

Key Responsibilities & Duties

• Develop and optimize chromatographic methods for gas and liquid phase separations.
• Perform structure characterization and elucidation using mass spectrometry and NMR data.
• Collaborate with cross-functional teams for analytical method transfer and qualification.
• Ensure compliance with industry standards in analytical development processes.
• Prepare and review technical documents for analytical methods and protocols.
• Provide training and guidance on analytical techniques to team members.
• Monitor and maintain analytical equipment for optimal performance.
• Contribute to impurity profiling and limit setting for materials analysis.

Job Requirements

• Ph.D. in Analytical Chemistry, Organic Chemistry, or related field with 1+ years of biopharmaceutical experience.
• Master's degree with 5+ years of biopharmaceutical experience in chromatographic separation and method development.
• Proficiency in HPLC, UPLC, GC, and mass spectrometry techniques.
• Strong knowledge of chromatographic separation mechanisms and method optimization.
• Experience with Waters and Agilent analytical hardware and software systems.
• Excellent communication, writing, and reviewing skills.
• Self-motivated and detail-oriented with a focus on analytical excellence.
• Familiarity with Empower, Masslynx, Masshunter, and XCalibur CDS preferred.