الوصف الوظيفي
MARC for Medical Services and Scientific Research is an integrative research center that aims to advance science by conducting research in interdisciplinary disease areas.
Our goal is to conduct high-priority and ethical basic, preclinical and clinical research, bridging the gap between science and community to improve health and quality of life.
MARC is looking to have an experienced candidate for Bioequivalence Laboratory Manager Key responsibilities: Oversee all analytical laboratory operations related to bioequivalence studies, including method development, validation, and sample analysis.
Ensure full compliance with GLP, GCP, and regulatory requirements during in-vitro and in-vivo study activities.
Manage and supervise LC-MS/MS, HPLC, and other analytical platforms used for bioanalytical testing.
Lead laboratory teams, assign tasks, monitor performance, and ensure proper training and competency of staff .
Coordinate with clinical, bioanalytical, and quality assurance teams to ensure smooth execution of bioequivalence studies.
Review and approve analytical protocols, validation reports, study reports, and SOPs .
Ensure proper instrument calibration, maintenance, and laboratory resource management .
Support regulatory inspections and audits by maintaining data integrity and documentation compliance .
Troubleshoot analytical or operational issues and implement continuous improvement strategies in laboratory processes.
Bachelor’s degree in Pharmacy or Science (mandatory).
Master’s degree in Analytical Chemistry (mandatory).
PhD in Analytical Chemistry or related field (preferred).
Strong knowledge of GLP, and regulatory compliance in bioequivalence studies.
Extensive experience with bioanalytical techniques such as LC-MS/MS, HPLC, and method validation.
Solid understanding of both in-vitro and in-vivo bioequivalence study requirements .
Proven leadership and laboratory management experience .
Strong skills in data review, regulatory documentation, and quality systems .
Excellent problem-solving, organizational, and communication skills .
لقد تمت ترجمة هذا الإعلان الوظيفي بواسطة الذكاء الاصطناعي وقد يحتوي على بعض الاختلافات أو الأخطاء البسيطة.
