Sr. Analytical Chemist - IVD Reagents and Small Molecules

Sr. Analytical Chemist – IVD Reagents and Small Molecules Location: Molecular Diagnostics Business Unit, Des Plaines, Illinois Benefits Career development with an international company where you can grow the career you dream of. Employees can qualify for 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, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. Responsibilities Analytical Method Development & Testing 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. Instrument Ownership & Troubleshooting 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. Documentation, Quality, & Regulatory Compliance 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. Cross‑Functional Support & Investigation Leadership 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. Training & Mentorship Train and mentor junior staff in analytical techniques, instrument best practices, and data‑integrity requirements. Required Qualifications 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. Preferred Qualifications Proficiency in LC‑MS for detailed oligonucleotide and small‑molecule characterization is also preferred. 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. Abbott is an Equal Opportunity Employer, committed to employee diversity. The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr