Job Description

• Conduct studies under non GLP or GLP (Good Laboratory Practice) system compliant with US FDA and OECD GLP principles, including method validation.
• Pharmacokinetic and immunogenicity studies and other investigations.
• Manage work areas to ensure scientific integrity of studies conducted in such areas.
• Supervise and train study personnel including technicians, research assistants and interns on study/laboratory techniques, proper use of equipment and SOPs and report writing.
• Understand study background, objectives, design and criteria, and have full understanding of/familiarity with investigational drugs or medical devices to conduct studies in a high scientific quality and to train and guide study staff, interns and technicians.
• Assist in management and supervision of day-to-day laboratory operations and personnel including lab maintenance and monitoring, and study data recording, report and SOPs writing and dossier compilations for regulatory filing
• Assist in preparation and coordination of regulatory inspections and guests visits/inspections.
• Any additional duties as directed by Head of Research and Development.General Requirements
• PhD in biomedical science, life science or equivalent
• Prior research and development experience are required.
• Knowledge in method validation, GLP and ISO17025 is a plus.
• Proficient in ligand binding assay platforms, including ELISA
• Good understanding of method development and validation parameters
• Proficient with office management software (MS office, Teams), and statistical tools (Prism, SPSS, or PLA)
• Effective project and people management skills
• Ability to lead a team
• Good interpersonal skills
• Good written and verbal communication skills
• Superior problem solving and troubleshooting skills, attention to details