Pre-Clinical Research

Roles & Responsibilities:
• Conduct Analytical, Physicochemical, and Five-Batch Analysis studies in compliance with regulatory requirements
• Ensure adherence to OECD GLP principles and applicable international test guidelines (OECD, EPA, OPPTS, CIPAC, WHO/FAO, etc.)
• Act as Study Director responsible for planning, execution, monitoring, and reporting of assigned studies
• Serve as the primary point of contact for sponsor queries, optimization requests, and regulatory requirements
• Support method development, procedure optimization, and standardization activities
• Review and approve study protocols, raw data, and final reports ensuring regulatory readiness
• Maintain effective cross-functional coordination with analytical, QA, and regulatory teams
• Ensure laboratory safety compliance and proper hazardous waste management
• Support audits, inspections, and regulatory submissions as required

Qualification:
• M.Sc / M.Pharm (Master of Pharmacy) in Chemistry, Analytical Chemistry, or related disciplines

Experience:
• 3–8 years of experience in a GLP-certified CRO environment
• Hands-on expertise in analytical and physicochemical testing, preferably including Five-Batch Analysis for agrochemicals

Skills:
• Strong understanding of Study Director responsibilities under GLP framework
• In-depth knowledge of international regulatory guidelines (OECD, EPA, OPPTS, CIPAC, WHO/FAO)
• Excellent analytical, problem-solving, and decision-making skills
• Strong documentation and regulatory reporting capabilities
• Effective sponsor communication and stakeholder management skills

About the Organization:
Anthem Biosciences is a leading GLP-certified CRO specializing in pre-clinical research and development services across pharmaceuticals and agrochemicals, committed to delivering high-quality, regulator-ready data through global compliance standards.