QC Analytical Scientist

Reporting to the QC Analytical Lead, the QC Analytical Scientist will serve as a technical expert in analytical chemistry testing and laboratory operations in support of drug product manufacturing at WuXi STA’s Middletown, DE site.

Responsibilities

• Perform and review QC analytical testing for drug products, raw materials, packaging components, and stability samples in accordance with approved methods and SOPs.
• Execute advanced analytical techniques including HPLC, UPLC, GC, dissolution, UV-Vis, TOC, Karl Fischer, and other relevant compendial and non-compendial methods.
• Troubleshoot analytical instrumentation and methods, supporting investigations and continuous improvement.
• Author, review, and revise test methods, SOPs, and technical documents.
• Mentor and train QC Analysts and Associates in analytical techniques and best practices.
• Ensure all activities are conducted in strict compliance with cGMP, safety, and quality standards.
• Maintain accurate, complete, and inspection-ready laboratory documentation.
• Participate in method transfer, qualification, and validation of analytical methods and equipment.
• Support client and regulatory audits by presenting data, explaining technical approaches, and preparing responses.
• Escalate deviations, out-of-specification (OOS) results, or atypical findings promptly to the QC Analytical Manager.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline with 5+ years of QC analytical laboratory experience in a GMP-regulated pharmaceutical or biotechnology environment; OR
• Master’s degree with 3+ years or PhD with 1+ years of relevant QC analytical laboratory experience.
• Deep expertise in chromatographic and spectroscopic methods (HPLC/UPLC, GC, UV-Vis, TOC, KF, etc.) and data interpretation.
• Demonstrated ability to lead laboratory investigations, troubleshoot instrumentation, and author technical reports.
• Strong knowledge of GMP regulations, ICH guidelines, and data integrity principles (ALCOA+).

Preferred Qualifications

• Experience in method transfer, qualification, and validation of analytical methods.
• Familiarity with LIMS, Empower, or other electronic laboratory management systems.
• Prior experience in a CDMO or multi-client environment.
• Strong communication and collaboration skills to support cross-functional teams, audits, and regulatory inspections.