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 quality assurance support for bacterial endotoxin testing across pharmaceutical, biotechnology, medical device, and related healthcare products. The successful candidate will review endotoxin testing strategies, evaluate laboratory data, assess method suitability, investigate atypical results, and support compliance with applicable pharmacopeial and regulatory requirements. This fully remote role requires strong knowledge of bacterial endotoxin testing, Limulus Amebocyte Lysate (LAL) methodologies, recombinant Factor C (rFC) assays, method suitability, validation principles, and pharmaceutical quality systems. The specialist will collaborate remotely with qualified laboratory personnel, quality assurance teams, microbiologists, manufacturing groups, and regulatory stakeholders. Key Responsibilities Provide technical oversight for bacterial endotoxin testing programs involving pharmaceutical products, biologics, raw materials, water systems, and medical devices. Review endotoxin testing protocols, specifications, analytical procedures, and laboratory work instructions. Assess the suitability of applicable testing methodologies, including gel-clot, turbidimetric, chromogenic, and recombinant Factor C methods. Review method qualification, verification, validation, and transfer documentation. Evaluate product-specific interference testing, inhibition and enhancement studies, and maximum valid dilution calculations. Review endotoxin recovery results and assess the suitability of test conditions for different product matrices. Evaluate analytical data, calculations, controls, standard curves, and acceptance criteria. Review laboratory records for compliance with applicable pharmacopeial requirements, including USP and Ph. Eur. standards. Assess endotoxin limits and their scientific justification in accordance with relevant product specifications and regulatory expectations. Investigate out-of-specification, out-of-trend, atypical, and invalid endotoxin test results. Provide technical guidance for laboratory investigations, root-cause analysis, and corrective and preventive actions. Review testing records for compliance with good laboratory practices, good manufacturing practices, and data integrity requirements. Support environmental monitoring and pharmaceutical water system endotoxin testing review programs. Assess endotoxin-related risks associated with raw materials, manufacturing processes, equipment, and product contact surfaces. Review sampling strategies, sample handling requirements, storage conditions, and test preparation documentation. Coordinate remotely with microbiology laboratories, contract testing organizations, quality control teams, and manufacturing stakeholders. Evaluate laboratory trends and recurring endotoxin findings to identify potential contamination risks. Support the preparation and review of endotoxin testing sections for validation packages, quality reports, and regulatory submissions. Maintain technical review records, testing summaries, investigation documentation, and method lifecycle records. Monitor changes in pharmacopeial chapters, regulatory guidance, and industry practices related to bacterial endotoxin testing. Recommend improvements to testing procedures, analytical controls, laboratory documentation, and quality oversight processes. Qualifications and Experience Bachelor's degree in Microbiology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, or a related scientific discipline. Master's degree in Microbiology, Pharmaceutical Microbiology, or a relevant field is an advantage. Significant professional experience in bacterial endotoxin testing, pharmaceutical microbiology, microbiological quality control, or quality assurance. Strong understanding of bacterial endotoxins, lipopolysaccharides, and their relevance to pharmaceutical and medical device safety. Practical knowledge of LAL testing methodologies, including gel-clot, kinetic turbidimetric, and kinetic chromogenic techniques. Familiarity with recombinant Factor C assays and their appropriate application. Experience reviewing endotoxin method suitability, inhibition and enhancement testing, and recovery studies. Knowledge of endotoxin limit calculations, maximum valid dilution, and product-specific acceptance criteria. Understanding of relevant USP, European Pharmacopoeia, and other applicable pharmacopeial requirements. Experience reviewing analytical method qualification, verification, validation, and transfer documentation. Knowledge of pharmaceutical microbiology, aseptic processing, contamination control, and environmental monitoring. Familiarity with pharmaceutical water systems and endotoxin monitoring programs. Experience investigating out-of-specification results, laboratory deviations, and unexpected endotoxin trends. Understanding of GMP, GLP, CAPA, change control, and laboratory data integrity requirements. Experience with laboratory information management systems and electronic laboratory documentation platforms. Strong analytical, technical writing, and problem-solving capabilities. Excellent attention to detail and ability to review complex laboratory data independently. Ability to coordinate with laboratory teams and quality stakeholders in a fully remote working environment. Relevant professional certifications or specialized training in pharmaceutical microbiology and endotoxin testing are desirable. What We Offer A 100% remote working arrangement within the UAE employment context. Opportunities to support pharmaceutical microbiology and product quality programs. Exposure to established endotoxin testing methodologies and international quality standards. Professional development in microbiological testing, analytical quality, and regulatory compliance. A collaborative environment focused on scientific accuracy, product safety, and continuous improvement. How to Apply Interested candidates should submit an updated CV highlighting their bacterial endotoxin testing experience, LAL and recombinant Factor C methodology knowledge, method suitability expertise, and pharmaceutical quality assurance background. 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 structured as a fully remote technical review, documentation, data analysis, and laboratory oversight role. Physical sample preparation, laboratory testing, instrument operation, and experimental activities must be performed by appropriately trained and qualified local laboratory personnel. Formal laboratory approvals, regulated quality decisions, and regulatory submissions must be completed or authorized by appropriately qualified and authorized personnel. Show more Show less