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 provide technical oversight and analytical quality review for bacterial endotoxin testing programs across pharmaceutical products, biological materials, medical devices, and relevant manufacturing processes. This role focuses on reviewing endotoxin test data, evaluating method suitability, assessing laboratory investigations, and supporting compliance with applicable pharmacopeial and regulatory requirements. The successful candidate will bring strong knowledge of bacterial endotoxin testing, analytical methods, microbiological quality principles, and GMP documentation.

Key Responsibilities

• Provide technical oversight of bacterial endotoxin testing programs for raw materials, in-process samples, finished products, and relevant pharmaceutical components.
• Review endotoxin testing protocols, analytical procedures, acceptance criteria, and laboratory-generated results.
• Evaluate the suitability of bacterial endotoxin testing methods, including gel-clot, chromogenic, and turbidimetric techniques.
• Review data generated using Limulus Amebocyte Lysate (LAL) and recombinant factor C (rFC) methods, where applicable.
• Assess method suitability, inhibition and enhancement testing, dilution strategies, and product interference considerations.
• Review endotoxin standard preparation records, calibration data, control results, and reagent qualification documentation.
• Evaluate assay performance, including sensitivity, specificity, precision, reproducibility, and acceptance criteria.
• Review endotoxin limits and their application to relevant product specifications and testing requirements.
• Assess laboratory deviations, invalid test results, out-of-specification findings, and out-of-trend observations.
• Support root cause analysis and corrective and preventive action planning for endotoxin testing issues.
• Review laboratory equipment qualification, calibration, maintenance, and analytical system performance records.
• Monitor trends in endotoxin results across batches, products, manufacturing stages, and stability programs.
• Coordinate with quality control, microbiology, quality assurance, manufacturing, and regulatory affairs teams.
• Review laboratory procedures, method validation reports, test worksheets, and controlled documentation.
• Support investigations involving water systems, raw materials, manufacturing components, and potential endotoxin contamination sources.
• Assess the impact of process changes, product formulation changes, and supplier variations on endotoxin testing methods.
• Maintain technical review records, investigation summaries, data integrity evidence, and audit-ready documentation.
• Support internal and external audits by providing technical explanations of endotoxin testing controls and documentation.
• Monitor applicable USP, Ph. Eur., JP, ICH, and GMP requirements relevant to bacterial endotoxin testing.
• Recommend improvements to testing oversight, laboratory documentation, analytical review procedures, and quality monitoring practices.

Qualifications and Experience

• Bachelor's or Master's degree in Microbiology, Pharmaceutical Sciences, Biotechnology, Biochemistry, Chemistry, or a related discipline.
• Significant experience in pharmaceutical microbiology, bacterial endotoxin testing, quality control, or microbiological quality assurance.
• Strong understanding of bacterial endotoxins, pyrogens, endotoxin contamination risks, and relevant testing principles.
• Practical knowledge of LAL testing methods, including gel-clot, kinetic chromogenic, and kinetic turbidimetric techniques.
• Familiarity with recombinant factor C methods and alternative endotoxin testing technologies is advantageous.
• Experience reviewing inhibition and enhancement studies, method suitability assessments, and validation or verification reports.
• Knowledge of endotoxin limits, product-specific testing requirements, and applicable pharmacopeial standards.
• Understanding of GMP, data integrity, laboratory investigations, deviation management, and CAPA processes.
• Experience reviewing microbiological laboratory records, analytical data, reagent qualification, and equipment documentation.
• Familiarity with laboratory information management systems and electronic quality management systems.
• Strong analytical reasoning and ability to investigate complex laboratory data and testing discrepancies.
• Excellent technical writing, documentation, and communication skills.
• Ability to coordinate technical reviews and quality activities across remote, cross-functional teams.
• Relevant professional certifications or postgraduate qualifications in microbiology, pharmaceutical quality, or analytical sciences are advantageous.

What We Offer

• A fully remote working arrangement based in the UAE.
• Competitive compensation aligned with experience and technical expertise.
• Opportunities to support pharmaceutical microbiological quality and contamination control programs.
• Exposure to regulated laboratory testing methods and international pharmacopeial standards.
• A collaborative environment focused on scientific integrity and continuous quality improvement.

How to Apply

Submit your CV highlighting your experience in bacterial endotoxin testing, LAL or rFC methods, method suitability, laboratory investigations, and GMP quality systems. Include details of the pharmaceutical products, testing techniques, or quality control programs you have supported.

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

Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer.

• Role boundary: This is a fully remote technical oversight, analytical data review, and documentation assessment position. Physical sample handling, reagent preparation, endotoxin testing, instrument operation, calibration, laboratory experiments, and microbiological work must be performed by qualified local laboratory personnel in appropriately equipped facilities. The specialist reviews laboratory-generated results and provides technical recommendations without independently conducting physical laboratory procedures. Formal batch release decisions, validated method approvals, GMP certifications, regulatory submissions, and statutory quality or regulatory sign-offs must be completed or approved by appropriately authorized professionals.