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Senior Molecular Diagnostic Assay Specialist

DEV PLUS CODE · United Arab Emirates

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Job Title: Senior Molecular Diagnostic Assay Specialist

Location: United Arab Emirates (Remote)Employment Type: Full-TimeWork Arrangement: 100% Remote — Work From HomeLevel: SeniorAbout the RoleThe Senior Molecular Diagnostic Assay Specialist is responsible for providing technical expertise in the evaluation, optimisation, validation documentation, and performance monitoring of molecular diagnostic assays.

The role focuses on reviewing assay design information, analysing validation data, assessing analytical performance, investigating documented assay deviations, and supporting continuous improvement across molecular diagnostic workflows.Working remotely with molecular biologists, clinical laboratory scientists, quality assurance teams, research professionals, and diagnostic laboratory managers, the specialist helps ensure that molecular testing methods are supported by robust technical evidence, controlled documentation, and appropriate quality practices. This is a remote technical and analytical position. Physical laboratory procedures, specimen handling, instrument operation, clinical result authorisation, and regulated diagnostic decisions must be performed by appropriately qualified and authorised local personnel.Key ResponsibilitiesReview molecular diagnostic assay protocols, technical specifications, validation plans, and performance documentation.Evaluate assay design characteristics, including target selection, primer and probe information, amplification conditions, and detection methodology.Analyse assay validation data relating to analytical sensitivity, specificity, precision, reproducibility, and robustness.Review evidence supporting limit of detection, reportable range, inclusivity, exclusivity, and cross-reactivity assessments.Assess documented performance of PCR, real-time PCR, digital PCR, nucleic acid amplification, and other relevant molecular diagnostic technologies.Examine assay verification and validation records for completeness, consistency, traceability, and compliance with approved procedures.Review quality control data, control acceptance criteria, and documented monitoring of assay performance.Analyse trends in assay failures, invalid results, contamination events, and unexpected amplification patterns using available laboratory records.Support documented root-cause investigations into assay deviations, performance concerns, and recurring technical issues.Recommend evidence-based improvements to assay protocols, acceptance criteria, documentation practices, and quality monitoring processes.Review reagent and consumable qualification records, including lot-to-lot comparison data and stability documentation.Assess documentation relating to extraction efficiency, amplification performance, inhibition monitoring, and internal control results.Support the evaluation of assay transfer, method comparison, and inter-laboratory performance data.Review change-control documentation for modifications to assay components, instruments, software, reagents, or testing procedures.Prepare technical summaries, validation reports, assay performance dashboards, and management review presentations.Maintain structured records of assay versions, validation evidence, deviations, corrective actions, and technical decisions.Collaborate remotely with laboratory teams to clarify technical documentation and resolve discrepancies in assay records.Support the preparation of technical files and evidence packages for laboratory accreditation, quality audits, and regulatory assessments.Monitor developments in molecular diagnostic technologies, assay validation standards, and relevant scientific literature.Contribute to the development and maintenance of standard operating procedures, technical guidance, and assay review checklists.Provide remote technical guidance to laboratory personnel on documentation quality, assay performance review, and validation requirements.Protect confidential patient-related, laboratory, research, and proprietary assay information in accordance with applicable policies.Qualifications and ExperienceBachelor's degree in Molecular Biology, Medical Laboratory Science, Biotechnology, Genetics, Biochemistry, Microbiology, Biomedical Science, or a related discipline.Master's degree or PhD in Molecular Diagnostics, Molecular Biology, Clinical Laboratory Science, Biotechnology, or a related field is preferred.Significant experience in molecular diagnostic assay development, validation, verification, technical review, or laboratory quality assurance.Strong understanding of nucleic acid extraction, amplification, detection, and molecular testing principles.Practical knowledge of PCR, real-time PCR, digital PCR, and other relevant molecular diagnostic platforms.Experience reviewing analytical validation parameters, including sensitivity, specificity, precision, reproducibility, and limit of detection.Understanding of primer and probe design principles, amplification efficiency, assay controls, and potential sources of analytical interference.Familiarity with contamination prevention, carryover control, inhibition assessment, and molecular laboratory quality practices.Experience reviewing assay verification records, method comparison studies, quality control results, and technical deviation reports.Knowledge of relevant laboratory quality management systems and recognised standards for medical laboratory testing.Familiarity with applicable molecular diagnostic regulatory requirements and accreditation expectations.Ability to interpret complex technical datasets and identify meaningful assay performance trends.Proficiency in spreadsheet applications, statistical analysis tools, and technical reporting software.Experience with laboratory information management systems or molecular diagnostic data platforms is an advantage.Strong technical writing skills, including the ability to prepare validation summaries, controlled procedures, and audit-ready documentation.Excellent analytical, organisational, and problem-solving abilities, with strong attention to detail.Ability to communicate effectively with laboratory scientists, quality teams, clinical stakeholders, and technical management.Ability to work independently, manage multiple technical reviews, and collaborate effectively in a fully remote environment.What We OfferA 100% remote working arrangement based in the United Arab Emirates.Opportunities to contribute to molecular diagnostic quality, assay performance, and laboratory improvement initiatives.Collaboration with multidisciplinary laboratory, scientific, and quality assurance professionals.Opportunities for professional development in molecular diagnostics, assay validation, and laboratory quality systems.A technically focused role involving scientific analysis, documentation review, and continuous improvement.How to ApplyInterested candidates should submit an updated CV highlighting their experience in molecular diagnostic assays, assay validation, molecular biology, laboratory quality assurance, or related technical disciplines.Application Subject: Application – Senior Molecular Diagnostic Assay Specialist (UAE Remote)Candidates should confirm applicable employment arrangements, residency requirements, and work authorisation before accepting an offer. This position is 100% remote and does not require routine on-site attendance. Physical specimen collection, sample preparation, laboratory testing, instrument operation, and other hands-on procedures must be performed by qualified local laboratory personnel. Clinical interpretation, release of diagnostic results, formal regulatory submissions, and any regulated laboratory sign-offs must remain with appropriately licensed or authorised professionals.