Site Head - Biopharmaceutical Operations

Position: Site Head
Designation: SGM/ Vice President
Department: Operations
Experience: 20–25 Years
Location: Kathua, Jammu

Job Purpose
The Site Head will lead and manage the complete operations of a large-scale biotechnology fermentation manufacturing facility, ensuring safe, compliant, efficient, and profitable plant performance. The role will oversee Production (USP, DSP & SRP), Engineering, Quality, Fermentation Process, Supply Chain, Stores, Finance, HR/Admin, Utilities, EHS, and Infrastructure functions.
The incumbent will be responsible for driving operational excellence, process optimization, regulatory compliance, strategic growth, and people leadership across the site.

Key Responsibilities
1. Manufacturing & Plant Operations
Lead overall site operations for fermentation-based biotechnology manufacturing plant.
Ensure smooth functioning of USP (Upstream Processing), DSP (Downstream Processing), PP & SRP operations.
Achieve production targets with optimum yield, quality, and efficiency.
Monitor batch performance, process stability, and operational KPIs.
Ensure maximum utilization of manpower, equipment, and utilities.
Drive productivity improvement and operational excellence initiatives.

2. Fermentation & Process Management
Provide strategic and technical leadership for large-scale fermentation operations.
Oversee inoculum preparation, fermentation process control, and pilot plant activities.
Ensure process consistency, contamination control, and batch success rate improvement.
Support scale-up and commercialization of new fermentation technologies.
Lead troubleshooting and process optimization initiatives.

3. Engineering & Utilities Management
Oversee engineering, maintenance, utilities, automation, instrumentation, and infrastructure functions.
Drive preventive and predictive maintenance systems.
Lead automation, PLC, DCS, and digital manufacturing initiatives.
Manage plant expansion and capital projects.

4. Quality & Regulatory Compliance
Ensure compliance with GMP, GLP, ISO, environmental, and statutory regulations.
Lead QA, QC, microbiology, documentation, validation, and compliance activities.
Ensure audit readiness for customer, regulatory, and certification audits.
Drive strong quality culture and continuous compliance improvements.

5. EHS & Sustainability
Promote a strong safety culture across the organization.
Ensure implementation of EHS policies and statutory compliance.
Monitor environmental performance including ETP/ZLD operations.
Lead risk assessment, incident investigation, and emergency preparedness programs.
Drive sustainability and energy optimization initiatives.

6. Supply Chain & Inventory Management
Oversee procurement planning, raw material availability, and inventory optimization.
Ensure efficient coordination between production planning, procurement, stores, and dispatch.
Monitor supply continuity and vendor management activities.

7. Financial & Commercial Management
Manage plant budgets, manufacturing costs, and operational expenses.
Drive cost optimization without compromising quality or safety.
Monitor utility costs, manpower productivity, and resource utilization.
Support business profitability and growth strategies.

8. Leadership & Team Management
Lead cross-functional teams across manufacturing, engineering, quality, SCM, finance, and HR.
Build a high-performance and accountable work culture.
Develop succession planning and capability-building initiatives.
Drive employee engagement and retention programs.

Span of Control
The Site Head will oversee the following major functional teams:
Production
USP
DSP
SRP
Engineering & Utilities
Mechanical, Civil & Infrastructure
Electrical/ Instrumentation
Automation / PLC / DCS
Boiler & Utility Operations
ETP / ZLD Operations
Quality
QA
QC
Microbiology
Validation & Compliance
Documentation
Fermentation
Process Excellence
Inoculum Fermentation Team
Pilot Plant Operations
Support Functions
Supply Chain
Stores
Finance
HR & Administration
Security

Educational Qualification
 Master’s Degree in Biotechnology, Chemical Engineering, Bioprocess Engineering, or related field.
 MBA / Management qualification will be an added advantage.

Experience Required
20–25 years of experience in Biotechnology / Fermentation / Chemical manufacturing industry.
Minimum 10 years in senior plant leadership role.