QC Raw Material Scientist (Pharmaceutical)

TL;DR

QC Raw Material Scientist (Analytical Chemistry): Performing and reviewing analytical testing of raw materials, APIs, and excipients for pharmaceutical manufacturing with an accent on compendial standards and cGMP compliance. Focus on executing chromatographic and spectroscopic methods, leading laboratory investigations (OOS/OOT), and ensuring the uninterrupted supply of qualified materials.

Location: On-site in Middletown, DE

Company

A leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform company.

What you will do

• Perform and review QC analytical testing of raw materials, APIs, and packaging components using HPLC, UPLC, GC, and FTIR.
• Conduct laboratory investigations for out-of-specification (OOS), out-of-trend (OOT), and atypical results.
• Author and revise raw material specifications, test methods, protocols, SOPs, and technical reports.
• Mentor and train QC Analysts on testing techniques, GMP requirements, and laboratory best practices.
• Collaborate with Warehouse, Procurement, and Quality Assurance teams to ensure timely material disposition.
• Support the qualification, validation, and transfer of analytical methods and laboratory instrumentation.

Requirements

• Bachelor's degree in Chemistry or related field with 5+ years of GMP experience (or Master's with 3+ / PhD with 1+).
• Expertise in HPLC/UPLC, GC, FTIR, UV-Vis, TOC, and Karl Fischer techniques.
• Strong understanding of USP, EP, JP, ICH, FDA, and cGMP regulations.
• Proven experience leading laboratory investigations and troubleshooting instrumentation.
• Must be based in or able to work on-site in Middletown, DE.

Nice to have

• Experience supporting raw material programs in CDMO environments.
• Familiarity with LIMS, Empower, or SAP systems.
• Experience with supplier qualification and vendor change assessments.
• Experience performing FTIR identity testing and compendial verification.

Culture & Benefits

• Equal Opportunity Employer ensuring non-discrimination regardless of race, religion, or background.
• Opportunity to work in a highly regulated, professional scientific environment.
• Collaborative cross-functional team structure.