Analytical Chemist - IVD Reagents and Small Molecules
- 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.
- 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.
- 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.
- 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.
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