Sr. Analytical Chemist – IVD Reagents and Small Molecules

What You’ll Work On

1. 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.

1. 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.

1. 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

1. 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.

1. 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

• 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.

Apply Now

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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.

JOB FAMILY:

Manufacturing

DIVISION:

AMD Molecular

LOCATION:

United States > Des Plaines : DP01

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Routine work with chemicals, Work in a clean room environment

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

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