Microbiologist

Medline•Mundelein, IL

About The Position

Under minimal supervision, serves as the technical subject matter expert (SME) for bacterial endotoxin testing. Independently performs, leads, and oversees BET activities for raw materials, in process materials, finished products, and stability samples in accordance with USP, ISO, and applicable compendial requirements. Provides technical leadership, compliance oversight, and cross functional support.

Requirements

Bachelor’s degree in Microbiology or related scientific discipline.
5+ years experience in QC and/or R&D microbiology with demonstrated BET expertise.
Strong working knowledge of USP <85>, <161>, and endotoxin related guidance.
Proficient in LIMS and standard laboratory software.

Nice To Haves

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.

Responsibilities

Act as BET SME for the laboratory, business divisions, and internal customers.
Independently perform and lead endotoxin testing (gel clot, kinetic chromogenic/turbidimetric) for QC and R&D samples.
Author, review, and approve BET methods, validations/verifications, protocols, and reports.
Lead method suitability, interference assessments, troubleshooting, and continuous improvement initiatives.
Review and approve test data, calculations, and results for accuracy, completeness, and compliance.
Lead OOS, OOCAL, deviation, and investigation activities related to endotoxin testing.
Provide regulatory and audit support, including inspection readiness, technical justifications, and establishing product families for medical device products.
Identify testing gaps, perform gap analyses, and drive risk based solutions.
Mentor and provide technical guidance to junior microbiology staff.
Ensure full compliance with GLP, data integrity, and laboratory safety expectations.