Job Summary

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.

Job Description

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.

Qualifications:

• 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 , and endotoxin related guidance.
• Proficient in LIMS and standard laboratory software.
• Preferred Qualifications
• 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.

Preferred Qualifications:

• 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.

The anticipated salary range for this position:

$67,000.00 - $101,000.00 Annual
The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click

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We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page

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