QC Analytical Scientist (Pharmaceutical)

TL;DR

QC Analytical Scientist (Pharmaceutical): Executing and troubleshooting analytical chemistry testing and laboratory operations for drug product manufacturing with an accent on chromatographic methods, stability studies, and GMP compliance. Focus on leading laboratory investigations, authoring technical reports, and ensuring regulatory readiness for inspections.

Location: On-site in Middletown, DE

Company

A global pharmaceutical and biotechnology CDMO provider specializing in drug product manufacturing and analytical services.

What you will do

• Perform and review QC analytical testing for drug products, raw materials, and stability samples using HPLC, UPLC, GC, and other techniques.
• Troubleshoot analytical instrumentation and methods to support investigations and continuous improvement.
• Author, review, and revise test methods, SOPs, and other technical documentation.
• Mentor and train QC Analysts and Associates in analytical techniques and laboratory best practices.
• Support client and regulatory audits by presenting data and explaining technical approaches.
• Collaborate on the method transfer, qualification, and validation of analytical methods and equipment.

Requirements

• Bachelor's degree in Chemistry or related field with 5+ years of GMP experience, or Master's with 3+ years, or PhD with 1+ year.
• Deep expertise in chromatographic and spectroscopic methods (HPLC/UPLC, GC, UV-Vis, TOC, KF) and data interpretation.
• Demonstrated ability to lead laboratory investigations and author technical reports.
• Strong knowledge of GMP regulations, ICH guidelines, and ALCOA+ data integrity principles.
• Must be based in or able to work on-site in Middletown, DE.

Nice to have

• Experience in method transfer, qualification, and validation of analytical methods.
• Familiarity with LIMS, Empower, or other electronic laboratory management systems.
• Prior experience working within a CDMO or multi-client environment.

Culture & Benefits

• Equal opportunity employer committed to diversity, equity, and inclusion.
• Opportunity to serve as a technical expert within a high-compliance, global regulatory environment.
• Collaborative professional culture focused on quality and technical excellence.