GM Production

Job Description: General Manager (GM) – API ProductionThe General Manager (GM) of API Production is responsible for leading end\-to\-end manufacturing operations at an Active Pharmaceutical Ingredient (API) or Bulk Drug production plant. This leadership role ensures that high\-volume manufacturing blocks meet production targets on time, optimize chemical yields, reduce conversion costs, and strictly adhere to global regulatory guidelines and safety compliance.1\. Key ResponsibilitiesOperations \& Production Excellence

• **Target Adherence:** Direct and monitor daily, monthly, and annual API manufacturing operations to meet commercial and export commitments.
• **Asset Utilization:** Optimize the capacity utilization of multi\-product or dedicated API manufacturing blocks, equipment (reactors, centrifuges, ANFDs, cleanrooms), and workforce.
• **Yield \& Cost Control:** Drive process optimization to improve product yields, reduce cycle times, minimize solvent consumption, and lower the conversion cost per kilogram.
• **Technology Transfer:** Partner with R\&D and Process Engineering for seamless scale\-up, validation, and commercialization of new APIs.

Regulatory, Quality, \& Compliance

• **cGMP \& Data Integrity:** Enforce strict adherence to Current Good Manufacturing Practices, Good Documentation Practices, and stringent data integrity policies across all batch execution records.
• **Audit Readiness:** Serve as the core host and leader for stringent regulatory inspections from global agencies like the USFDA, EMA, PMDA, and ANVISA.
• **QMS Management:** Lead the resolution of quality deviations, Out of Specification results, and market complaints by performing root cause analysis and deploying corrective and preventive actions.

EHS (Environment, Health, \& Safety) \& Utilities

• **Process Safety:** Oversee safe handling of hazardous chemicals, exothermic reactions, and high\-pressure hydrogenations.
• **Resource Coordination:** Collaborate with engineering teams to minimize utility breakdowns and monitor zero\-liquid discharge or effluent treatment plant compliance.

Leadership \& People Management

• **Team Guidance:** Mentor and lead a large multi\-layered team consisting of production managers, plant executives, and shop\-floor operators.
• **Capability Building:** Systematically track skill matrices and drive regular training on safety, technical standard operating procedures, and advanced plant automation.

2\. Core Key Performance Indicators (KPIs)

• **Production Delivery:** Percentage adherence to monthly production schedule and timeline targets.
• **Yield \& Quality:** Material balance efficiency, batch failure/rejection rate, and yield improvement percentages.
• **Cost Efficiency:** Drop in conversion cost per unit/kg and optimized solvent recovery metrics.
• **Audit \& Compliance:** Number of critical or major observations during regulatory audits (Target: Zero).
• **Safety Metrics:** Zero reportable accidents or Lost Time Injury Frequency Rate.

3\. Job Requirements \& Qualifications

• **Education:** B.Tech / B.E. in Chemical Engineering or M.Sc. in Organic Chemistry.
• **Experience:** 15 to 22\+ years of hands\-on experience in API / Bulk Drug manufacturing, with at least 5 years in a senior management position.
• **Regulatory Exposure:** Mandatory track record of successfully clearing major international audits, specifically USFDA or EU\-GMP compliant facilities.
• **Technical Skills:** Sound knowledge of chemical unit operations (crystallization, distillation, filtration), automated plant control systems (PLC/DCS), and Quality Management Systems software.

Pay: ₹1,100,000\.00 \- ₹2,100,000\.00 per year

Benefits

• Food provided
• Leave encashment
• Paid sick time
• Provident Fund

Application Question(s)

• What is your total years of experience ?
• What is your relevant years of experience ?
• Mention your current CTC ?
• Mention your expected CTC ?
• If selected, how soon you can join ?

Work Location: In person