Job Title: Analytical Chemist Ion Chromatography & HPLC Location: Des Plaines, Illinois
Position Summary:
We are seeking an experienced Analytical Chemist with deep expertise in ion chromatography (IC) and high-performance liquid chromatography (HPLC) to support the development and validation of reagents and raw materials used in in vitro diagnostic (IVD) assays. This role is critical to ensuring the quality, consistency, and regulatory compliance of analytical methods used in the development and manufacturing of diagnostic products.
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 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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