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 robust 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 (India)
🏢 BDR Pharmaceuticals
📍 India