Fermenta Biotech Limited
Website:
fermentabiotech.com
Job details:
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
· 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.
· 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.
· 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.
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