
location_onSouth Lake Street, Mundelein, Lake County, Illinois, 60060, United States
As a Technical Subject Matter Expert for bacterial endotoxin testing (BET), you will serve as the primary authority for the laboratory, business divisions, and internal customers. In this role, you will independently perform, lead, and oversee BET activities for raw materials, in-process materials, finished products, and stability samples. Your work ensures compliance with USP, ISO, and other applicable compendial requirements while providing technical leadership and cross-functional support.
You will drive continuous improvement by leading method suitability assessments, interference studies, and troubleshooting initiatives. Beyond daily testing, you will author, review, and approve BET methods, validations, protocols, and reports. You will also take the lead on Out-of-Specification (OOS), Out-of-Control (OOCAL), and deviation investigations related to endotoxin testing, ensuring data integrity and accuracy throughout the process.
Your day will involve a blend of hands-on laboratory leadership and strategic oversight. You will guide junior microbiology staff, providing mentorship and technical guidance to build team capability. You will collaborate with R&D and QC teams to identify testing gaps and implement risk-based solutions. Additionally, you will prepare for and support regulatory audits, providing technical justifications and establishing product families for medical device products to ensure inspection readiness.
Medline Industries, LP is a growing worldwide organization dedicated to creating an environment where everyone feels they belong and can grow their career. We strive to achieve this by seeking diversity in all forms, acting inclusively, and ensuring our people have the tools and resources to perform at their best.
To apply, please submit your resume and relevant qualifications through our careers portal. Candidates selected for the next steps will be contacted directly by our recruiting team to discuss the opportunity further.
Medline Industries, LP is an equal opportunity employer. We evaluate qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Work model: On-site
South Lake Street, Mundelein, Lake County, Illinois, 60060, United States
Mundelein, Illinois
Experience with Recombinant Factor C (rFC) Assay. Prior experience supporting regulatory inspections and responding to audit observations. Demonstrated ability to function independently as a recognized technical expert.
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Skills: Bacterial Endotoxin Testing, Gel Clot, Kinetic Chromogenic, Turbidimetric, Usp, Iso, GLP, Data Integrity, Lims, Recombinant Factor C Assay.
Education: Bachelor's degree in Microbiology or related scientific discipline required.