Senior Executive - R&D Synthesis (API)

Key Responsibilities:

• Design and develop synthetic routes for APIs and intermediates based on literature or novel approaches.
• Perform lab-scale synthesis, process optimization, and reaction condition screening.
• Develop and validate robust, scalable, and cost-effective synthetic processes.
• Conduct impurity profiling, route selection, and critical parameter evaluation.
• Coordinate with Analytical R&D, QA/QC, and Production teams for seamless technology transfer.
• Prepare R&D reports, process development reports, and documents for regulatory submissions.
• Participate in troubleshooting at the plant level during scale-up or commercial production.
• Ensure all experiments are conducted in compliance with GMP, GLP, and EHS norms.
• Maintain proper lab documentation, notebooks, and data integrity.
• Monitor industry trends and literature for continuous improvement and innovation.

Qualifications:

• M.Sc. (Organic Chemistry) or Ph.D. in Organic Chemistry or related field.
• 4–7 years of hands-on experience in API synthesis in a pharmaceutical R&D environment.
• Strong knowledge of organic chemistry, reaction mechanisms, and process safety.

Key Skills:

• Expertise in multi-step organic synthesis and process development.
• Familiarity with analytical tools (HPLC, GC, NMR, LC-MS) and data interpretation.
• Knowledge of ICH, GMP, and regulatory expectations for APIs.
• Problem-solving, scientific writing, and project management abilities.