Job Description

Job Title: Analytical Chemist Ion Chromatography & HPLC

Location: Des Plaines, Illinois

Key Responsibilities:

• Develop and validate IC and HPLC methods for the characterization of raw materials, buffers, and critical reagents used in IVD assays.
• Support reagent and assay development teams by providing analytical data to guide formulation, stability, and performance optimization.
• Operate, maintain, and troubleshoot analytical instrumentation, including IC and HPLC systems with various detectors (e.g., UV, conductivity, MS).
• Design and execute method robustness and transfer studies to support product development, tech transfer, lifecycle management, and regulatory submissions
• Generate and review technical documentation, including protocols, validation reports, and SOPs, in compliance with IVD regulatory standards (e.g., FDA, ISO 13485, CLSI).
• Collaborate with R&D, Quality, and Manufacturing teams to support product development, process validation, and root cause investigations.
• Interpret complex analytical data and generate technical reports, protocols, and SOPs in
• Ensure compliance with regulatory guidelines (FDA, ICH, USP, etc.) and internal quality systems.
• Train and mentor junior staff in analytical techniques and instrumentation best practices.

• Bachelor's, Master's, or Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, or a related field.
• 5+ years of hands-on experience in IC and HPLC method development, preferably in the IVD, medical device, or pharmaceutical industry.
• Strong understanding of analytical method validation in a regulated environment (FDA, ISO 13485, ICH).
• Proficiency with analytical software (e.g., Chromeleon, Empower, ChemStation) and data integrity principles.
• Familiarity with IVD assay components, such as enzymes, antibodies, and buffers, is highly desirable.
• Excellent documentation, communication, and problem-solving skills.

• Experience with biologics, enzymes, or complex matrices.
• Familiarity with other analytical techniques such as GC, CE, or spectroscopy.
• Knowledge of data integrity principles and electronic laboratory systems (e.g., LIMS, ELN).
• Knowledge of design control and risk management in the context of IVD product development.
• Prior experience supporting 510(k) or PMA submissions is a plus

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