QC Raw Material Scientist (Pharmaceutical Manufacturing)

Location: Middletown, Delaware, United States; on-site

Company

hirify.global supports pharmaceutical manufacturing operations through its WuXi STA site in Middletown.

What you will do

• Perform and review QC analytical testing of raw materials, APIs, excipients, process materials, and packaging components.
• Execute, troubleshoot, transfer, and validate compendial and non-compendial methods using HPLC, UPLC, GC, FTIR, UV-Vis, TOC, Karl Fischer, and wet chemistry techniques.
• Conduct investigations into OOS, OOT, atypical results, and laboratory deviations, implementing scientifically sound corrective actions.
• Support supplier qualification, material assessments, sampling strategies, and timely material disposition.
• Author and review specifications, test methods, protocols, SOPs, technical reports, and investigation documentation.
• Mentor QC Analysts and collaborate with Warehouse, Manufacturing, Procurement, Quality Assurance, and Supply Chain teams.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline with 5+ years of QC analytical laboratory experience in a GMP-regulated pharmaceutical or biotechnology environment; alternatively, a Master’s degree with 3+ years or a PhD with 1+ years of relevant experience.
• Strong experience with raw material release testing, compendial testing, and material disposition.
• Expertise in chromatographic, spectroscopic, and wet chemistry techniques, including HPLC/UPLC, GC, FTIR, UV-Vis, TOC, Karl Fischer, and pharmacopeial methods.
• Experience leading laboratory investigations, troubleshooting instrumentation, and authoring technical reports.
• Strong understanding of USP, EP, JP, ICH, FDA, and cGMP requirements applicable to raw material testing.
• Strong technical writing skills for specifications, SOPs, protocols, and investigation reports.

Nice to have

• Experience with raw material programs in pharmaceutical manufacturing or CDMO environments.
• Experience with supplier qualification, vendor change assessments, and material risk evaluations.
• Experience with FTIR identity testing, compendial verification, method transfers, validation, and regulatory inspections.
• Familiarity with LIMS, Empower, SAP, or similar laboratory and ERP systems.

Culture & Benefits

• Work in a GMP-regulated pharmaceutical manufacturing environment.
• Support site startup and commercial operations by establishing raw material testing capabilities.
• Contribute to continuous improvement initiatives focused on laboratory efficiency, compliance, and turnaround times.
• Participate in audits and regulatory inspections and provide technical responses related to raw material testing programs.