Site Head

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 strong 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.

Mandatory Experience & Qualifications

• 20+ years of overall experience in API / Pharmaceutical manufacturing.
• Proven experience as Plant Head / Site Head / Operations Head / senior manufacturing leader.
• Must have worked in a USFDA-approved / USFDA-inspected pharmaceutical manufacturing facility.
• Must have personally led or played a significant leadership role in USFDA audits/inspections.
• Strong experience in Oncology / Cytotoxic API manufacturing.
• Hands-on exposure to large-scale manufacturing processes involving:
  
• Large-scale reactors
• Hydrogenation
• Spray Drying
• Complex API synthesis
• Strong understanding of GMP, regulatory compliance, quality systems and process safety.
• Experience in managing large manufacturing teams and multiple site functions.
• Strong commercial understanding of cost, productivity, yield and CAPEX management.

Preferred Profile

The ideal candidate should be a strong manufacturing and business leader, rather than only a functional production expert.

Preference will be given to candidates who have:

• Managed a large API manufacturing site.
• Experience with regulated markets, particularly the US market.
• Successfully handled USFDA inspections with positive outcomes.
• Experience in high-potency / oncology / cytotoxic APIs.
• Managed significant CAPEX and capacity expansion projects.
• Experience in building and developing second-line leadership.
• Strong stakeholder management and communication skills.

Candidate Profile

Education: B.E./B.Tech/M.Tech in Chemical Engineering / Pharmacy / relevant technical discipline. MBA/PG qualification will be an advantage.

Experience: 20+ years

Industry: Pharmaceutical / API / Oncology / Specialty Chemicals

Level: GM / Sr. GM / VP

Location: Padra, Vadodara, Gujarat

Critical Requirement:
USFDA plant experience + leadership exposure in USFDA audits + Oncology/Cytotoxic API experience + large-scale reactor/Hydrogenation/Spray Drying exposure.