HPLCMass SpectroscopyChromatographyAnalytical Method Validation
Stefanini Group is hiring!Stefanini is looking for Research Scientist for Round Lake, IL quick Apply, please reach out to Shubham Singh - call: / email: Work shift (days/times) - Mon-Fri (40 hours) 1st shift
Work Location - Round Lake, IL Description:Perform analytical method development, validation, and chemical analysis associated with material characterization including; LC with MS detection. May perform ICP-MS, and wet chemical techniques (titrations, pH, UV, and TOC). Perform validation of analytical methods for quantitative analysis. Interact with change control teams to gather and evaluate information from material suppliers. Essential Responsibilities:Independently execute analytical testing following written test procedures and study protocols, process and document results per GXP regulations, and review data for accuracy and completeness.Apply analytical separation and detection techniques for complex impurity identification/ and execute method validation and transfer studies.Assess the technical feasibility of complex research and design concepts.Contribute to the analytical problem-solving efforts to meet urgent business needs.Collaborate with other functions such as project management, regulatory, formulation, engineering, manufacturing, and quality control in project teams.Collaborate with client's external partners to ensure successful execution of analytical testing and study designs.Maintain knowledge of relevant QSR and other regulatory requirements related to R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, is able to provide expert advice and/or is an active participant in the generation, review, adoption and interpretation of such focus on meeting both external and internal customer expectations.
Qualifications:Bachelor's degree in relevant scientific discipline (chemistry, pharmaceutical sciences) with 5-7 years' experience or Masters' degree with 3-5 years' experience or PhD with 0-3 years' experience.Proficient at MS and LC/MS analysis.Experienced with analytical method development, validation, and transfer in pharmaceutical regulated with extractables and leachables testing and Elemental Impurities is desiredA good understanding of ICH, USP guidelines and cGxP practice.Familiarity and hands-on experience with HPLC, UV, MassHuner and other analytical instruments and software.Ability to learn quickly and to solve problems in a timely manner using analytical chemistry skills.Possess relevant writing and computer skills.Ability to design experiments and draw meaningful conclusions from lab in working in global cross-functional teams and project management is a plus.Quality oriented.Ability to adapt to changes and to work in a team environment. Who We AreThe Stefanini Group is a global provider of offshore, onshore, and nearshore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than 400 clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting, company with a global presence. We are CMM Level 5 Company.