Job Description Site Head / Plant Head – API

Company: BDR Group
Location: Padra, Vadodara, Gujarat
Level: GM / Sr. GM / VP
Experience: 20+ Years
Function: API Manufacturing / Operations
Reporting To: Senior Management

Position Overview

We are looking for an experienced Site Head / Plant Head – API to lead the overall operations of our API manufacturing site at Padra, Vadodara.

The role requires a robust manufacturing leader with extensive experience in USFDA-regulated pharmaceutical manufacturing, particularly in Oncology/Cytotoxic API products and complex manufacturing processes.

Key Responsibilities
- Lead the complete API manufacturing site, including Production, Quality, Engineering, EHS, Warehouse and other site functions.
- Ensure achievement of production, quality, cost, productivity and delivery targets.
- Drive a strong GMP and Quality culture across the site.
- Lead and manage USFDA inspections/audits, including preparation, inspection handling and closure of observations.
- Ensure compliance with USFDA, WHO-GMP, EU-GMP,



CDSCO and other applicable regulatory requirements.
- Manage large-scale API manufacturing operations involving:
- Large-scale reactors
- Hydrogenation
- Spray Drying
- Solvent handling and recovery
- Complex chemical synthesis processes
- Drive manufacturing excellence, process optimisation, yield improvement and reduction of batch failures/rejections.
- Ensure effective CAPA, deviation, change control and investigation systems.
- Partner with R&D;, Quality, Regulatory, Engineering and Commercial teams for smooth technology transfer and scale-up.
- Develop site manpower, leadership capability and succession planning.
- Drive EHS, process safety and operational discipline across the plant.
- Manage site budgets, CAPEX and operating costs.
- Build a culture of accountability, continuous improvement and operational excellence.
- Represent the site before regulatory authorities, customers and senior management whenever required.

Mandator

📌 Site Head (Vadodara)
🏢 BDR Pharmaceuticals
📍 Vadodara