Description

Role Summary:

The Executive role at Biocon Biologics Limited is focused on ensuring effective and compliant upstream manufacturing operations within the Biosimilars Production Upstream B5 department. The position encompasses planning, execution, monitoring, and control of shift-based manufacturing activities associated with the production of monoclonal antibodies.

Key areas include handling cell culture processes and inoculum operations, maintaining cGMP compliance, managing operational teams, and ensuring smooth cross-functional coordination. The role demands a proactive approach to problem-solving, equipment management, and adherence to regulatory standards.

Key Responsibilities:

• Schedule, plan, execute, monitor, and control shift-based manufacturing operations.
• Oversee upstream operations for cell culture processes and inoculum operations related to monoclonal antibody production.
• Prepare and review cGMP documents, including SOPs, batch records, checklists, protocols, and reports.
• Handle single-use bioreactors and maintain proficiency in aseptic operations.
• Ensure equipment and facility compliance through calibration, preventive maintenance, and validation programs.
• Organize workflow by assigning responsibilities and preparing work schedules to achieve production targets.
• Manage and mentor a small team of experienced employees in downstream operations.
• Analyze and resolve equipment, process, and operational issues effectively and promptly.
• Coordinate with cross-functional teams to facilitate smooth operational processes and achieve departmental objectives.
• Represent the department during internal and external audits, ensuring the highest standards of cGMP and EHS compliance.

Key Technical Skills:

Upstream Operations, Cell Culture Processes, Inoculum Operations, cGMP Documentation, SOP Preparation, Single Use Bioreactors, Aseptic Operations, Equipment Calibration, Preventive Maintenance, Validation Programs, Batch Records, Process Troubleshooting, Cross-Functional Coordination, EHS Compliance

Requirements:

• B.Tech degree is mandatory.
• 0–7 years of relevant experience in upstream manufacturing operations, particularly in biopharmaceutical production.
• Hands-on experience with single-use bioreactors and aseptic operations.
• Strong understanding of cGMP practices and compliance.
• Capability to prepare and review technical documents like SOPs, protocols, and batch records.
• Good organizational skills for workflow management and scheduling.
• Ability to analyze and resolve operational problems swiftly.
• Strong team coordination and mentoring skills.
• Willingness to handle audits and ensure regulatory compliance.

Department Details:

This role is part of the Biosimilars Production Upstream B5 department, which is central to Biocon Biologics’ manufacturing operations focused on biologics and biosimilar products. The team emphasizes quality, regulatory compliance, and operational excellence to deliver world-class biopharmaceuticals.