Process Development Manager

Spc Life Sciences; Ankleshwar; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Spc Life Sciences in Ankleshwar, Gujarat seeks a Process Development specialist to design, optimize and establish robust, commercially viable processes for APIs, intermediates and specialty chemicals. The role covers lab to pilot-scale scale-up and tech transfer to manufacturing.

You will optimize parameters, solvents, catalysts, and purification methods, work closely with QA, QC, Production and EHS, generate development reports and ensure GMP, process safety and regulatory compliance.

Qualifications

• Strong knowledge of organic chemistry and chemical process development.
• Hands-on API/intermediate process development and scale-up experience.
• Good understanding of reaction chemistry, purification and crystallization.
• Strong problem-solving and process troubleshooting abilities.
• Familiar with GMP, process safety and EHS.

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.

Skills

Organic chemistry

Process development

Scale-up

GMP compliance

Purification & crystallization

Analytical interpretation

Cross-functional collaboration

Job description

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.