Analytical Chemist – Ion Chromatography & HPLC

Des Plaines, IL - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Analytical Chemist Ion Chromatography & HPLC
Location: Des Plaines Illinois

Experience - 4.5-8 Years

Skill (Primary) - Domain Competencies (ERS)-Medical Devices-IVD-IVD

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:

Bachelors Masters 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.

Job Title: Analytical Chemist Ion Chromatography & HPLC Location: Des Plaines Illinois Experience - 4.5-8 Years Skill (Primary) - Domain Competencies (ERS)-Medical Devices-IVD-IVD Position Summary: We are seeking an experienced Analytical Chemist with deep expertise in ion chromatography (IC...

Job Title: Analytical Chemist Ion Chromatography & HPLC
Location: Des Plaines Illinois

Experience - 4.5-8 Years

Skill (Primary) - Domain Competencies (ERS)-Medical Devices-IVD-IVD

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:

Bachelors Masters 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.