General Manager / Site Head - Manufacturing

Fermenta Biotech Limited; Kullu; On-site; INR 5,000,000 - 12,000,000; Full time

Job summary

Fermenta Biotech Limited seeks a seasoned manufacturing leader to head Biotech, API, and premix operations. The role requires deep cGMP expertise, multi-product facility management, and a track record of regulatory compliance and performance improvement.

The candidate will oversee technology transfer, scale-up, and validation, coordinating across planning, maintenance, and EHS functions while driving lean initiatives and cost optimization in a large-scale manufacturing environment.

Qualifications

• 20+ years of experience with a minimum of 3–5 years as head of manufacturing in medium/large API companies; exposure in API manufacturing is mandatory.
• MSc in Chemistry or Biotechnology or Microbiology/ Biotech Engineering coupled with an MBA in operations management.

Responsibilities

• Oversee end-to-end manufacturing operations covering 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 production planning, maintenance, utilities, EHS, and engineering functions.
• Lead implementation of best practices and systems for multi-product plant operations, including batch handling and scheduling.
• Oversee the operation and maintenance of the Effluent Treatment Plant ensuring environmental compliance.
• Lead TPM partner onboarding and ensure alignment with quality, regulatory, cost and capacity requirements.

Skills

Manufacturing leadership

Operations management

Regulatory compliance

cGMP

Technology transfer

Quality assurance

Lean manufacturing

Project management

Team leadership

Education

MSc in Chemistry/Biotech/Microbiology

MBA in Operations Management

Job description

Experience : 20+ years’ experience with minimum 3-5 years as head of manufacturing in Medium / large sized API companies. (Exposure in API manufacturing is mandatory)

Education : MSc in Chemistry or Biotechnology or Microbiology / Biotech Engineering couple with an MBA in operations management.

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 lines—biotech, 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.

• 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.