Senior QC Raw Materials Scientist — Pharma Analytics

WuXi AppTec; Town of Middletown (NY); Vor Ort; USD 110.000 - 140.000; Vollzeit

Zusammenfassung

WuXi AppTec in Middletown, DE is seeking a QC Raw Material Scientist to lead analytical testing of incoming materials, APIs, excipients, and packaging components. You will execute regulatory-compliant methods, investigate OOS/OOT events, and support supplier qualification and material disposition.

The role requires strong chromatographic and wet-chemistry expertise, plus experience with GMP/data integrity. Collaboration with QA, Supply Chain, and Manufacturing is essential.

Qualifikationen

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline; 5+ years QC analytic lab in GMP environment.
• Master’s degree with 3+ years or PhD with 1+ years QC analytic lab experience.

Aufgaben

• Perform QC analytical testing of raw materials, APIs, excipients, and packaging components.
• Execute compendial and non-compendial methods (HPLC/UPLC, GC, FTIR, UV-Vis, TOC, Karl Fischer).
• Investigate OOS, OOT, and deviations; support material disposition and supplier qualification.
• Mentor QC Analysts and train on GMP requirements and lab practices.
• Support audits, inspections, and continuous improvement initiatives.

Kenntnisse

HPLC/UPLC

GC

FTIR

UV-Vis

TOC

Karl Fischer

Wet chemistry

OOS investigations

data integrity (ALCOA+)

GMP/cGMP

Ausbildung

Bachelor's degree in Chemistry/Pharmaceutical Sciences

Master's degree or PhD preferred

Tools

LIMS

Empower

SAP

Jobbeschreibung

WuXi AppTec in Middletown, DE is seeking a QC Raw Material Scientist to lead analytical testing of incoming materials, APIs, excipients, and packaging components. You will execute regulatory-compliant methods, investigate OOS/OOT events, and support supplier qualification and material disposition.

The role requires strong chromatographic and wet-chemistry expertise, plus experience with GMP/data integrity. Collaboration with QA, Supply Chain, and Manufacturing is essential.