Sr. Analytical Chemist - IVD Reagents and Small Molecules

Abbott • Des Plaines, IL

5d • Onsite

About The Position

At Molecular Diagnostics, we realize the potential of personalized care as the laboratory’s most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics. This position is for a Sr. Analytical Chemist – IVD Reagents and Small Molecules with deep expertise in ion chromatography (IC), high‑performance liquid chromatography (HPLC), and atomic absorption (AA) spectroscopy to support the development and validation of reagents, raw materials, and small molecules—including oligonucleotides and nucleic‑acid probes—used in in vitro diagnostic (IVD) assays. Proficiency in LC‑MS for detailed oligonucleotide and small‑molecule characterization is also preferred.

Requirements

• Master's or Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, or related field; Bachelor's with significant experience considered.
• 5+ years of analytical method development and validation experience in a regulated environment.
• Demonstrated expertise in IC, HPLC, AA, and LC‑MS for characterization of oligonucleotides, nucleic‑acid probes, and other small molecules.
• Familiarity with complementary material characterization techniques (e.g., UV‑Vis, Karl Fischer, TOC).
• Experience with GMP/GLP, method lifecycle, and regulatory documentation.
• Strong statistical foundation for method validation.

Nice To Haves

• Proficiency in LC‑MS for detailed oligonucleotide and small‑molecule characterization.
• Experience with biologics, enzymes, or complex matrices.
• 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.

Responsibilities

• Develop, optimize, and validate analytical methods using IC, HPLC, AA, and LC‑MS to support characterization of raw materials, reagents, oligonucleotides, nucleic‑acid probes, and other small molecules.
• Perform routine and non‑routine testing to ensure compliance with specifications for raw materials, intermediates, and finished reagents.
• Design and execute analytical experiments supporting IVD assay development, small‑molecule characterization, formulation optimization, and stability studies.
• Operate, maintain, and troubleshoot analytical instrumentation, including IC and HPLC systems equipped with UV, conductivity, and mass‑spectrometry detection.
• Maintain instrument readiness, calibration, and associated documentation in accordance with GMP/GLP requirements.
• Prepare and review validation protocols, test methods, technical reports, SOPs, and analytical sections of regulatory submissions.
• Ensure data integrity and compliance with 21 CFR 820, ISO 13485, and applicable FDA/ICH/USP guidelines.
• Generate, analyze, and interpret complex analytical data sets to support product development, investigations, and quality decision‑making.
• Lead analytical investigations, including root‑cause analysis, and provide technical recommendations for corrective and preventive actions (CAPA).
• Collaborate with R&D, Quality, Manufacturing, and other stakeholders to support product development, process validation, and material assessments.
• Serve as a subject‑matter expert in analytical methodologies, providing technical guidance to cross‑functional teams.
• Train and mentor junior staff in analytical techniques, instrument best practices, and data‑integrity requirements.

Benefits

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• The Freedom 2 Save student debt program.
• FreeU education benefit.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior