Senior Endotoxin Testing Specialist

Job Title: Senior Endotoxin Testing Specialist

Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Work Arrangement: 100% Remote — Work From Home

Level: Senior

About the Role

We are seeking an experienced Senior Endotoxin Testing Specialist to oversee bacterial endotoxin testing strategies, analytical data review, quality compliance, and laboratory testing documentation for pharmaceutical products, biologics, medical devices, and related materials. The successful candidate will provide technical expertise in endotoxin testing methodologies, method suitability assessments, validation, investigations, and quality assurance to support product safety and regulatory compliance.

This fully remote position focuses on technical oversight, test data evaluation, laboratory documentation review, and cross-functional coordination with quality control, quality assurance, microbiology, manufacturing, and regulatory affairs teams. The ideal candidate will have strong knowledge of bacterial endotoxin testing, compendial requirements, and Good Manufacturing Practice (GMP).

Key Responsibilities

• Provide technical oversight for bacterial endotoxin testing programs involving pharmaceutical products, biologics, raw materials, and medical devices.
• Review endotoxin testing results generated using appropriate methodologies, including gel-clot, kinetic turbidimetric, and kinetic chromogenic techniques.
• Evaluate analytical data for accuracy, completeness, consistency, and compliance with approved specifications.
• Support the development, review, and verification of endotoxin testing procedures and laboratory protocols.
• Assess method suitability, including interference testing, inhibition and enhancement assessments, and product-specific validation requirements.
• Review endotoxin limits and calculations in accordance with applicable product requirements and pharmacopoeial standards.
• Evaluate laboratory records, calculations, system suitability results, and associated quality documentation.
• Investigate out-of-specification, out-of-trend, atypical, or invalid endotoxin test results in collaboration with laboratory and quality teams.
• Support root cause analysis, corrective and preventive actions (CAPA), and the implementation of sustainable process improvements.
• Review endotoxin test method validation and verification reports for completeness and scientific soundness.
• Provide technical guidance on sample preparation, dilution strategies, reagent suitability, and potential assay interference.
• Monitor changes to relevant compendial standards, including applicable USP, European Pharmacopoeia, and other recognized requirements.
• Support GMP compliance assessments, internal audits, external inspections, and laboratory quality reviews.
• Review laboratory deviations, change controls, equipment qualification records, and procedural updates related to endotoxin testing.
• Coordinate with contract testing laboratories and external service providers to review results and resolve technical issues.
• Prepare technical reports, trend analyses, investigation summaries, and management presentations.
• Provide remote training and technical guidance to laboratory personnel on testing principles, documentation standards, and data integrity.
• Recommend improvements to testing workflows, quality controls, documentation practices, and laboratory performance monitoring.

Qualifications and Experience

• Bachelor's or master's degree in Microbiology, Pharmaceutical Sciences, Biotechnology, Biochemistry, Chemistry, or a related scientific discipline.
• Significant experience in bacterial endotoxin testing, pharmaceutical microbiology, quality control, or microbiological quality assurance.
• Strong understanding of bacterial endotoxin testing principles and relevant compendial methods.
• Practical knowledge of gel-clot, kinetic chromogenic, and kinetic turbidimetric assay methodologies.
• Experience reviewing method suitability, inhibition and enhancement testing, and analytical validation or verification data.
• Knowledge of applicable pharmacopoeial requirements, including USP bacterial endotoxin testing provisions and relevant European Pharmacopoeia standards.
• Understanding of GMP, laboratory quality systems, and data integrity requirements.
• Experience investigating out-of-specification results, laboratory deviations, and atypical analytical findings.
• Familiarity with CAPA, root cause analysis, change control, and risk assessment processes.
• Ability to interpret analytical data, review laboratory records, and assess compliance with approved procedures.
• Experience with laboratory information management systems (LIMS), electronic laboratory records, or quality management systems.
• Strong technical writing, documentation review, and analytical problem-solving skills.
• Excellent communication and stakeholder coordination abilities.
• High attention to detail and the ability to manage multiple investigations and quality deliverables.
• Ability to work independently and collaborate effectively with geographically distributed teams.

What We Offer

• A fully remote, work-from-home arrangement.
• Competitive compensation based on experience and qualifications.
• Opportunities to contribute to pharmaceutical quality, microbiological control, and product safety programs.
• Collaboration with multidisciplinary teams across quality control, quality assurance, manufacturing, and regulatory affairs.
• Professional development and opportunities for career progression.

How to Apply

Interested candidates should submit an updated CV highlighting their experience in bacterial endotoxin testing, analytical method suitability, laboratory quality systems, GMP compliance, and technical data review.

Application Subject: Application – Senior Endotoxin Testing Specialist (UAE Remote)

• Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer. This position is designed for remote technical oversight, analytical data review, documentation assessment, and quality coordination. Physical sample preparation, laboratory testing, reagent handling, and instrument operation must be performed by appropriately trained personnel at qualified laboratory facilities. Formal quality approvals and regulatory submissions must be completed or authorized by appropriately designated personnel in accordance with applicable requirements.