Analytical Development Scientist

About This Role

This contract role supports critical analytical development and GMP documentation activities within a growing analytical development team at a leading biopharmaceutical organization. It is an excellent opportunity for a scientist with strong separation sciences expertise and a passion for data quality, compliance, and analytical excellence. Working closely with Analytical Development leadership, you will review laboratory documentation, support analytical method activities, and ensure development data meets the highest standards of GMP compliance and regulatory integrity.

Responsibilities

• Review analytical development laboratory notebooks for GDP compliance, completeness, accuracy, and data integrity
• Evaluate analytical methods and supporting data to ensure suitability for development objectives
• Provide technical expertise across separation-based analytical platforms including HPLC / UPLC, Reverse Phase (RP-HPLC), Ion Exchange Chromatography (IEX), Size Exclusion Chromatography (SEC), Hydrophobic Interaction Chromatography (HIC), Gas Chromatography (GC), CE-SDS, and cIEF
• Review analytical methods to ensure compliance with GMP and internal quality standards
• Support qualification, validation, and transfer of analytical methods into QC environments
• Review qualification protocols, reports, and analytical development documentation
• Assist with preparation and review of development reports
• Review and contribute to Certificates of Testing (CoT) for development batch release and stability programs
• Support analytical investigations, chromatography troubleshooting, and system suitability assessments
• Ensure all documentation meets regulatory, GMP, GDP, and data integrity requirements

Requirements

• Bachelor's degree or higher in Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline
• 4+ years' experience in Analytical Development or Quality Control within a GMP-regulated pharmaceutical, biologics, or biotechnology environment
• Strong hands-on experience with HPLC/UPLC methodologies
• Experience reviewing analytical data, chromatograms, laboratory notebooks, protocols, and technical reports
• Working knowledge of GMP, GDP, and data integrity requirements
• Experience supporting method development, optimisation, qualification, validation, or transfer activities
• Strong attention to detail with excellent written and verbal communication skills

Nice to have:

• Biologics, protein, antibody, vaccine, or conjugate analytical experience
• CE-SDS, cIEF, SEC, RP-HPLC, IEX, and Empower software experience
• Stability testing and regulatory support activities