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 recent 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.

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.

📌 General Manager / Site Head - Manufacturing (Kullu)
🏢 Fermenta Biotech
📍 Kullu