General Manager / Site Head - Manufacturing

Fermenta Biotech Limited; Kullu; On-site; INR 4,500,000 - 7,000,000; Full time

Job summary

Fermenta Biotech Limited is seeking a dynamic Operations Leader to steer technical, operational, and administrative functions across Biotech, API, and premix manufacturing units. The role requires strong multi‑product facility management in a cGMP environment and a proven track record of operational excellence.

You will drive capacity expansion, automation, and lean initiatives, coordinate across planning, maintenance, EHS, and engineering, and oversee third‑party manufacturing partnerships to

Qualifications

• Experience managing multi-product facilities in a cGMP environment.
• Proven track record of operational excellence, regulatory compliance, and large-scale team leadership.

Responsibilities

• Oversee end-to-end manufacturing operations across Biotech, API, and premix production units.
• Drive operational performance in safety, quality, delivery, cost, and compliance targets.
• Lead technology transfer, scale-up, and validation for Biotech & API products.
• Coordinate across production planning, maintenance, utilities, EHS, and engineering functions.
• Implement best practices and systems for multi-product plant operations, including batch handling, scheduling, segregation, and contamination controls.
• Oversee the operation and maintenance of the Effluent Treatment Plant with environmental compliance.
• Ensure safe plant operations and adherence to EHS standards.
• Identify, evaluate, and onboard TPM partners to ensure alignment with quality, regulatory, cost, and capacity requirements.

Job description

Job role:

The role will lead technical, operational, and administrative functions across our Biotech, API, and premix manufacturing units.

The ideal candidate will have strong domain expertise in managing multi-product facilities in a cGMP-compliant environment, with a proven track record of achieving operational excellence, regulatory compliance, and large-scale team leadership.

Key Responsibilities

Operations & Technical Leadership:

• Oversee end-to-end manufacturing operations covering Biotech, API, and premix production units.
• Drive operational performance in line with safety, quality, delivery, cost, and compliance targets.
• Lead technology transfer, scale-up, and validation for Biotech & API products.
• Ensure seamless coordination across production planning, maintenance, utilities, EHS, and engineering functions.
• Lead implementation of best practices and systems for multi-product plant operations, including batch handling, scheduling, segregation, and contamination controls.
• Oversee the operation and maintenance of the Effluent Treatment Plant, ensuring full compliance with environmental norms.
• Ensure safe plant operations and adherence to EHS standards.
• Lead the identification, evaluation, and onboarding of third‑party manufacturing (TPM) partners, ensuring alignment with company quality, regulatory, cost, and capacity requirements; oversee ongoing operations and performance management of TPMs to ensure seamless production, compliance, and supply continuity.

Strategic Initiatives:

• Plan and implement capacity expansion, automation, and digitalization projects across all manufacturing areas.
• Drive continuous improvement and lean initiatives to optimize resource utilization and reduce operational waste.
• Align manufacturing strategy with organizational growth plans and new product introduction roadmaps.

Project & Regulatory Management:

• Mentor teams through successful project execution including greenfield and brownfield projects across biotech, API, and premix domains.
• Coordinate with regulatory authorities such as Factory Inspector, Pollution Control Board, FDA, Labour Commissioner, Electricity Board, etc. for licenses and approvals.
• Lead validation and implementation of systems aligned with USFDA, EDQM, FSSAI, WHO-GMP, and other global standards.

Compliance & Quality:

• Ensure robust cGMP compliance across all manufacturing linesbiotech, API, and premix.
• Drive readiness for audits, inspections, and customer visits by maintaining high-quality standards and documentation practices.
• Establish systems for effective process validation, change control, and deviation management.

Team Leadership & Administrative Oversight:

• Lead and inspire a cross‑functional team of 350+ employees across different manufacturing verticals.
• Foster a high-performance culture through structured performance reviews, capability development, and succession planning.
• Oversee plant budgeting, cost control, and CAPEX investment planning in line with strategic business goals.
• Ensure timely and accurate management reporting, MIS, and operations dashboards.