Job Description
MARC
We are hiring!
Bioequivalence
Lab Manager
Join MARC, a leading 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.
Main 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.
Requirements:
-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.
Apply Now!
https://lnkd.in/d54VFAVM