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

Perks:

- 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

📌 GM Production (Vapi)
🏢 Vital Laboratories
📍 Vapi