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.
Qualifications:- 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.
Preferred 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