Deputy General Manager (DGM) / Assistant General Manager (AGM) - Upstream Production (API)

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 Chemistry

Experience Required :

15+ years of progressive experience in API manufacturing , with significant expertise in upstream operations including reaction handling , crystallization , and phase separation .