PrimeLab Diagnostics · Dubai, UAE
Industry — Clinical Diagnostics and Pharmaceutical Testing
Employment Type — Full-time
Education RequirementMaster’s degree in life sciences.
Responsibilities Develop LC-MS/MS and HPLC methods for clinical diagnostics and pharmaceutical testing. Review the literature, purchase supplies, and prepare reagents, standards, and control materials.
* Evaluate the cost-effectiveness of new clinical and pharmaceutical tests.
* Validate new methods against applicable laboratory standards and internal and external requirements. Write and execute validation protocols, prepare validation reports, and assess the impact and risks of changes to products, equipment, processes, or test methods.
* Implement new testing procedures and establish standard operating procedures, quality control materials, instrument performance documentation, and reporting criteria.
* Test patient specimens and pharmaceutical samples using newly developed protocols. Review and report results within the role’s authorized scope and serve as the first point of contact for customer inquiries about results.
* Train staff on laboratory instruments, analytical methods, software, and procedures. Monitor staff performance, document competency assessments, and provide ongoing technical support.
* Work with the laboratory information system (LIS) to develop interfaces with instruments and reporting databases. Assess new or updated software and coordinate with applications support to resolve issues.
* Set up, validate, coordinate, and troubleshoot laboratory processes to support efficient operations, protect confidentiality, and meet applicable regulatory requirements.
* Work with the quality team to maintain ISO 15189 accreditation for medical laboratory testing and ISO/IEC 17025 accreditation for testing within the laboratory’s accredited scope*. Keep procedures and records current, including method validation, equipment calibration and maintenance, quality control, staff competency, and proficiency testing or external quality assessment, as applicable.
* Coordinate internal audits and external surveillance and reassessment visits. Investigate nonconformities, implement corrective actions, verify their effectiveness, and provide input for management reviews.
* Lead preparation for CAP inspections, as applicable.
Required Experience At least three years of hands-on experience developing and validating LC-MS/MS methods, with demonstrated experience in clinical diagnostics and pharmaceutical testing.
* Experience developing and validating analytical methods for active pharmaceutical ingredients (APIs), impurities, or finished pharmaceutical products.
* Hands-on experience maintaining accreditation under ISO 15189 and ISO/IEC 17025*, including audit preparation, assessment support, and follow-up on corrective actions.
* Experience using laboratory information systems.
* Experience training staff in mass spectrometry operation and troubleshooting.
Preferred Experience* Hands-on experience with Thermo Fisher mass spectrometry instruments.
