Analytical Chemist &ndash at Noblesoft Technologies

Job Title: Analytical Chemist Ion Chromatography & HPLC Location: Des Plaines Illinois 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. Preferred Skills: Experience with biologics enzymes or complex matrices. Familiarity with other analytical techniques such as GC CE or spectroscopy. 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 Key Skills Gas Chromatography,Laboratory Experience,Analytical Chemistry,FDA Regulations,Wet chemistry,Biochemistry,Chromatography,High-Performance Liquid Chromatography,Industrial Laboratory Experience,Spectroscopy,GLP,cGMP Employment Type : Full Time Experience: years Vacancy: 1