R & D manager

R&D Manager Key Responsibilities | API Pharmaceutical Company

• Lead API development, process development, and optimization activities from laboratory scale to commercial scale.
• Plan and manage R&D trials, process optimization, yield improvement, and impurity control.
• Drive scale-up, process validation, and technology transfer activities in coordination with Production, QA, and QC teams.
• Ensure compliance with GMP, GLP, SOPs, and regulatory requirements throughout R&D activities.
• Develop and review processes, specifications, analytical methods, SOPs, and technical documentation.
• Identify and implement cost-effective and efficient manufacturing processes for API production.
• Lead troubleshooting, root-cause analysis, and corrective/preventive actions (CAPA) for process-related issues.
• Coordinate with QA, QC, Production, Engineering, and Regulatory Affairs for successful project execution.
• Manage R&D projects, including timelines, resources, manpower, budgets, and project deliverables.
• Prepare and review R&D reports, development reports, batch records, validation documents, and technology-transfer documents.
• Support preparation of DMF/CTD and other regulatory documentation related to API development.
• Lead, train, and develop the R&D team of scientists, chemists, and technical staff.
• Evaluate new technologies and manufacturing approaches to improve quality, productivity, safety, and cost efficiency.