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

The Senior Endotoxin Testing Specialist is responsible for providing technical oversight, analytical data review, and quality documentation support for bacterial endotoxin testing across pharmaceutical products, biologics, medical devices, and relevant manufacturing materials. The role focuses on endotoxin testing methodologies, assay performance evaluation, laboratory data integrity, method suitability, investigation support, and compliance with applicable pharmacopeial and quality standards. Working fully remotely, the specialist collaborates with microbiology laboratories, quality control, quality assurance, manufacturing, validation, and regulatory affairs teams to support reliable testing practices and scientifically justified quality decisions.

Key Responsibilities

• Review and evaluate bacterial endotoxin testing data generated for pharmaceutical products, biologics, medical devices, and manufacturing materials.
• Provide technical guidance on established endotoxin testing methodologies, including gel-clot, kinetic turbidimetric, and kinetic chromogenic techniques.
• Review analytical results for compliance with applicable endotoxin limits, approved specifications, and testing procedures.
• Assess assay suitability, inhibition and enhancement studies, dilution schemes, and method verification documentation.
• Review laboratory protocols, analytical worksheets, instrument records, and test reports for completeness and consistency.
• Evaluate standard curves, positive product controls, negative controls, reference standards, and other assay performance indicators.
• Examine potential sources of analytical interference, including product matrix effects, sample preparation issues, and reagent-related variability.
• Review out-of-specification, out-of-trend, invalid assay, and atypical test results in coordination with authorized laboratory and quality personnel.
• Support investigations into endotoxin contamination risks, recurring test failures, and unexplained analytical discrepancies.
• Review method validation, verification, transfer, and suitability documentation for endotoxin testing procedures.
• Assess the scientific rationale for sample dilution, maximum valid dilution, endotoxin limits, and test acceptance criteria.
• Monitor laboratory quality indicators, testing trends, repeat-test frequency, and investigation outcomes.
• Coordinate with microbiology and quality control teams to resolve technical questions and documentation gaps.
• Review laboratory environmental monitoring summaries and contamination-control records where relevant to endotoxin risk assessment.
• Support the review of cleaning validation, equipment qualification, and process-control documentation related to endotoxin management.
• Evaluate corrective and preventive action proposals arising from endotoxin testing investigations.
• Maintain accurate technical review records, controlled documentation, data traceability, and audit evidence.
• Support internal audits, external inspections, and regulatory documentation reviews involving bacterial endotoxin testing.
• Monitor updates to relevant pharmacopeial requirements, including USP, Ph. Eur., and applicable regulatory guidance.
• Recommend improvements to assay documentation, analytical review procedures, laboratory controls, and quality reporting.

Qualifications and Experience

• Bachelor's degree in Microbiology, Pharmaceutical Sciences, Biotechnology, Biochemistry, Biomedical Science, or a related scientific discipline.
• A master's degree or relevant professional qualification in microbiology, pharmaceutical quality, or analytical science is an advantage.
• Significant experience in bacterial endotoxin testing, pharmaceutical microbiology, quality control, or microbiological quality assurance.
• Strong understanding of bacterial endotoxins, lipopolysaccharides, endotoxin limits, and contamination-control principles.
• Knowledge of gel-clot, kinetic chromogenic, and kinetic turbidimetric testing methodologies.
• Experience reviewing endotoxin assay results, method suitability studies, validation reports, and laboratory investigations.
• Familiarity with USP, Ph. Eur., and relevant pharmacopeial and regulatory requirements for endotoxin testing.
• Understanding of inhibition and enhancement testing, maximum valid dilution calculations, and product-specific method suitability.
• Knowledge of laboratory data integrity, good documentation practices, deviation management, and CAPA processes.
• Familiarity with laboratory information management systems, electronic laboratory notebooks, and analytical data platforms.
• Strong analytical reasoning and ability to interpret complex laboratory datasets.
• Excellent technical writing, documentation review, and reporting skills.
• High attention to detail and commitment to scientific accuracy and quality compliance.
• Ability to coordinate effectively with microbiology, quality, manufacturing, and regulatory teams.
• Ability to work independently and collaborate effectively in a fully remote environment.

What We Offer

• Fully remote working arrangement within the stated UAE-based role framework.
• Opportunity to contribute to pharmaceutical microbiological quality and contamination-control programs.
• Collaboration with laboratory scientists, quality professionals, and regulatory specialists.
• A professional environment emphasizing analytical reliability, data integrity, and patient safety.
• Opportunities for continued development in pharmaceutical microbiology and quality assurance.

How to Apply

Interested candidates should submit an updated CV highlighting their endotoxin testing experience, pharmaceutical microbiology knowledge, assay review capabilities, and familiarity with relevant pharmacopeial standards.

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 is a fully remote technical oversight and documentation review role. Physical sample handling, reagent preparation, laboratory testing, instrument operation, equipment calibration, and microbiological procedures must be performed by qualified local laboratory personnel in appropriately equipped facilities. Clinical or product-quality determinations, formal batch-release decisions, regulatory submissions, and statutory sign-offs must be completed by appropriately qualified and authorized personnel in accordance with applicable requirements.