OverviewReporting 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. This role includes advanced execution and troubleshooting of analytical methods, stability studies, method transfers, and equipment qualification, as well as maintaining compliance with GMP, corporate quality standards, and global regulatory requirements. The QC Analytical Scientist will play a critical role in both startup and steady-state operations, ensuring timely and accurate testing for product release, validation, and regulatory inspections.
ResponsibilitiesQC Analytical Testing and Support- 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.
- Other QC tasks assigned by analytical lead.
Regulatory Compliance and Documentation- 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.
Qualifications- 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.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
