Senior QC Raw Materials Scientist – GMP Analytics

WuXi AppTec Group; Town of Middletown (NY); On-site; USD 95,000 - 125,000; Full time

Job summary

WuXi AppTec Group seeks a QC Raw Material Scientist to lead analytical testing of incoming materials and support regulatory compliance at the Middletown site. You will execute and troubleshoot HPLC/UPLC, GC, FTIR, and related methods while ensuring data integrity and timely material release.

You will mentor analysts, author technical reports, and coordinate with QA, Supply Chain, and Manufacturing to sustain uninterrupted material supply and site startup readiness.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 5+ years of QC analytics in GMP.
• Master’s with 3+ years or PhD with 1+ year of QC analytics experience.
• Strong experience with raw material release testing and material disposition processes.
• Expertise in chromatographic, spectroscopic, and wet chemistry methods (HPLC/UPLC, GC, FTIR, UV-Vis, TOC, Karl Fischer).
• Experience leading investigations, troubleshooting instruments, and authoring technical reports.
• Knowledge of USP, EP, JP, ICH, FDA and cGMP requirements for raw material testing.
• Strong technical writing skills with experience authoring specifications and SOPs.

Responsibilities

• Perform and review QC analytical testing of raw materials, APIs, excipients, and packaging components.
• Execute compendial and non-compendial methods including HPLC, UPLC, GC, FTIR, UV-Vis, TOC, Karl Fischer.
• Support sampling plans and testing strategies for incoming materials.
• Conduct investigations for OOS/OOT and laboratory deviations related to raw materials.
• Troubleshoot instrumentation and implement corrective actions.
• Support supplier qualification and material assessments via analytical evaluation.
• Author, review, and revise specifications, test methods, protocols, SOPs, and reports.
• Mentor QC Analysts on testing techniques and GMP requirements.
• Collaborate with Warehouse, Manufacturing, Procurement, QA, and Supply Chain teams.
• Support capabilities establishment during site startup and commercial operations.

Skills

HPLC/UPLC

GMP compliance

Analytical methods

Troubleshooting instruments

Technical reporting

Cross-functional collaboration

Education

Bachelor’s degree in Chemistry or related

Master’s degree or PhD (relevant QC analytics)

Tools

LIMS

Empower

SAP

Job description

WuXi AppTec Group seeks a QC Raw Material Scientist to lead analytical testing of incoming materials and support regulatory compliance at the Middletown site. You will execute and troubleshoot HPLC/UPLC, GC, FTIR, and related methods while ensuring data integrity and timely material release.

You will mentor analysts, author technical reports, and coordinate with QA, Supply Chain, and Manufacturing to sustain uninterrupted material supply and site startup readiness.