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 solid 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.

📌 Site Head (Vadodara)
🏢 BDR Pharmaceuticals
📍 Vadodara