Key Responsibilities :
Production & Operations Management :
- Manage end-to-end upstream processes including chemical reactions , crystallization , solvent recovery , and work-up operations .
- Plan and execute daily production activities to meet output, quality, and yield targets.
- Monitor critical process parameters (CPPs) and ensure adherence to process design and safety.
Compliance & Documentation :
Ensure GMP compliance , and adherence to regulatory and safety guidelines (USFDA, EDQM, TGA, WHO).Review and approve Batch Manufacturing Records (BMRs) , SOPs , Deviation Reports , and Change Controls related to upstream activities.Prepare and support regulatory audits , customer audits , and internal inspections .People & Resource Management :
Lead and develop a team of shift engineers, supervisors, and operators .Schedule manpower, oversee training and ensure adherence to SOPs and safety practices .Foster a culture of accountability , teamwork , and continuous improvement .Process & Quality Improvement :
Collaborate with R&D, Technology Transfer, and QA / QC teams to ensure smooth tech transfer and scale-up of new products.Drive process optimization to improve yield, reduce cycle time , and minimize solvent loss .Lead investigation of deviations, process failures , and implement corrective actions .Plant & Equipment Oversight :
Oversee the operation and maintenance of key upstream equipment :Reactors (GLR / SSR), condensers, scrubbers, distillation units, receivers , etc.Coordinate with the Engineering team for preventive maintenance and equipment validation .Inventory & Cost Control :
Monitor raw material consumption, solvent usage, and utility consumption.Drive cost-reduction initiatives without compromising quality or compliance.Key Skills and Competencies :
Deep understanding of chemical reaction engineering and process safety .Expertise in hazardous reaction handling , including exothermic and pressure reactions.Sound knowledge of GMP , cGMP , ICH , and regulatory requirements .Strong leadership, team management, and problem-solving abilities.Proficiency in production software (e.g., SAP, DCS, MES) is an added advantage.Educational Qualifications :
B.E. / B.Tech in Chemical Engineering or equivalent OR M.Sc. in Chemistry / Organic Chemistry / Industrial ChemistryExperience Required :
15+ years of progressive experience in API manufacturing , with significant expertise in upstream operations including reaction handling , crystallization , and phase separation .