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Actalent Research Associate III in Round Lake, Illinois

Description:

This position will perform chemical analysis for chemical characterization of pharmaceutical packaging medical devices and delivery systems (“extractables and leachables”), method validation and testing assessments to meet the regulatory timing for Europe Medical Devices Regulation (MDR) across Baxter’s Renal Care and Acute Therapies businesses to sustain products. Responsibilities and Duties o Contribute to state-of-the-art chemical characterization (ISO 10993:18) / extractables & leachables studies by supporting information collection via laboratory testing activities, method feasibility, and preparation of samples for analysis. o With subject matter expert input, author and/or contribute to experimental protocols and reports. o Perform routine chemical analysis including LC and GC with and without MS detection, ICP-MS, titrations, pH, UV, and TOC. Perform chemical characterization testing in support of ISO10993-18 evaluation of medical devices. o Perform method qualification / time of use validation for E&L methods o Contribute to the design and execution of method validation and transfer studies o Evaluate analytical results, identify trends and exceptions and interpretation of results relative to product requirements, definitions and/or project goals. o Competent in interpreting complex analytical data and presenting in a form that is suitable for a wide-ranging audience. o Routinely share results and findings and provide assistance to team members regarding project work. o Demonstrate understanding of and adherence to governmental and international industry requirements, procedures, regulations, and standards related with EU-MDR, ISO 17025 and other applicable E&L standards and guidelines. o Able to communicate clearly with manager, peers, cross-functional teammates, and non-technical audiences by openly sharing project status and hurdles and seeking input from other team members.

Skills:

UPLC, GC, ICP-MS, LC, pH, UV, Pharmaceutical, GMP, GLP, GDP, Analytical Chemistry, Organic Chemistry, Leachables, Extractables, ICH, FDA, GC-MS, LC-MS, Medical Device, USP, ISO

Top Skills Details:

UPLC, GC, ICP-MS, LC, pH, UV, Pharmaceutical, GMP, GLP, GDP,Analytical Chemistry,Organic Chemistry,Leachables,Extractables,ICH,FDA,GC-MS,LC-MS,Medical Device

Additional Skills & Qualifications:

o Bachelor’s degree in a scientific discipline (such as Analytical or Organic chemistry) with 5-7 years, MS with least 3-5 years, or PhD with 0-3 years of experience in relevant discipline. o Experience in E&L testing and study design, Environmental Chemistry testing, and/or Compendial Materials testing preferred. o Required knowledge and application of analytical chemistry with relevant laboratory skills (wet Hands-on experience with wet chemical techniques and instrumental analysis including LC/MS/UV, GC/MS/FID, and ICP-MS). o Experience with analytical method development, validation and transfer requirements per ICH. o A good understanding of ICH, USP guidelines and cGxP practice.

Experience Level:

Entry Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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