12 Sep
|
Spc Life Sciences
|
Ankleshwar
12 Sep
Spc Life Sciences
Ankleshwar
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 current 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.
📌 Process Development Manager (Ankleshwar)
🏢 Spc Life Sciences
📍 Ankleshwar