Scientist - Analytical R&D

About the role

This position is within the Analytical Technologies team of the Applied Research department, focusing on implementing and managing analytical activities to support new product development, formulations, early-stage and late-stage clinical studies. The role involves developing, validating, and transferring analytical methods for drug product and drug substance, performing analytical testing for release and stability studies, evaluating data, and conducting trending analysis. You will collaborate with cross-functional groups and communicate data both verbally and through written reports while multitasking across projects.

Responsibilities

• Develop and validate analytical methods under supervision, utilizing a strong scientific background.
• Operate, maintain, and troubleshoot analytical equipment (e.g., HPLC/UPLC, FTIR, UV-Vis Spectrophotometer) while ensuring compliance with GLP/GMP standards.
• Troubleshoot analytical issues, provide support for investigations, and ensure high-quality scientific data generation. Evaluate and interpret results from release and stability studies.
• Perform bench-level drug product stability testing and release of test articles, generating accurate and precise data using advanced analytical technologies.
• Apply hands-on expertise in analytical methodologies for drug release, potency, stability, and impurity testing, demonstrating method suitability for drug product development.
• Prepare experimental protocols and well-written technical reports for regulatory submissions.
• Stay current with analytical sciences, investigate new technologies, and recommend innovative techniques while maintaining strong knowledge of ISO/GLP/GMP compliance.
• Perform other duties as assigned by management.

Requirements

• Bachelor’s degree in a scientific discipline (e.g., analytical chemistry, pharmaceutical chemistry, or pharmaceutical sciences) with 2–5 years of related experience, or a Master’s degree with 1–2 years of pharmaceutical industry experience.
• Strong scientific background and hands-on knowledge of chemical analysis principles, chromatographic theories, and technologies.
• Working knowledge of analytical methods (e.g., HPLC, UPLC, GC, dissolution, LC-MS, UV/Vis) and techniques for determining potency, purity, and in-vitro performance of drug substance and drug product.
• Ability to troubleshoot analytical problems at all stages of development.
• Experience with stability studies and trend analysis.
• Experience in a cGMP analytical laboratory is preferred.
• Demonstrated ability to learn new technologies and methodologies.
• Strong skills in developing, validating, and transferring analytical methods.
• Excellent verbal and written communication skills, with a detail- and results-oriented approach.
• Working knowledge of drug development regulations, including USP, FDA, and ICH guidance for analytical testing and stability assessments.