Process Development Manager

Key Responsibilities

• Develop, optimize and establish robust and commercially viable processes for APIs, pharmaceutical intermediates and specialty chemicals.
• Conduct laboratory and pilot-scale experiments for process optimization and scale-up.
• Optimize reaction parameters, solvents, catalysts, temperature, pressure, reaction time and work-up conditions to improve yield, purity and productivity.
• Develop processes with focus on cost reduction, higher yield, lower cycle time and improved process efficiency.
• Identify and control process-related impurities and develop suitable purification/crystallization techniques.
• Prepare process development reports, experimental records, process flow sheets and technical documentation.
• Support scale-up activities from lab scale to pilot/commercial scale.
• Coordinate with Production, QA, QC, Engineering and EHS during process trials and scale-up.
• Provide technical support for commercial batch troubleshooting, deviations and process-related problems.
• Conduct root-cause analysis and implement process improvement measures.
• Support technology transfer from R&D to manufacturing and ensure smooth implementation of developed processes.
• Evaluate alternate raw materials, solvents and process routes for improving process economics and sustainability.
• Prepare and maintain material balance, mass balance and process parameters for developed processes.
• Ensure process development activities comply with GMP, EHS, process safety and regulatory requirements.
• Support new product development and customer-specific process development requirements, wherever applicable.

Key Performance Areas

• New process development and successful scale-up.
• Improvement in yield, purity and productivity.
• Reduction in manufacturing cost and cycle time.
• Successful technology transfer to manufacturing.
• Reduction in process deviations and batch failures.
• Timely completion of process development projects.
• Development of safe, consistent and commercially viable processes.

Required Skills

• Strong knowledge of organic chemistry and chemical process development.
• Hands-on experience in API/intermediate process development and scale-up.
• Good understanding of reaction chemistry, purification and crystallization.
• Strong process troubleshooting and problem-solving ability.
• Knowledge of GMP, process safety and EHS.
• Good technical documentation and analytical interpretation skills.
• Ability to work effectively with cross-functional teams.