Job Description

Department Details
Role Summary

• Scheduling, planning, executing, monitoring and control of shift based manufacturing operations.
• Responsible for the Upstream operations for the manufacturing of cell culture processes & Inoculum Operations for the production of monoclonal antibodies
• Preparation and review of cGMP documents like SOP, batch records, checklists, protocols and reports.
• Handling of single use bioreactors, good in Asceptic Operations handling.
• Maintaining the equipment and facility in a state of compliance with effective calibration, preventive maintenance and validation programs.
• Organizing workflow by assigning responsibilities and preparing work schedules to meet the production targets.
• Managing and mentoring a small group of experienced employees for downstream operations.
• Analysing and resolving equipment, process and operational problems in an effective and timely manner.
• Coordinating with cross functional teams for the smooth functioning of operations to achieve the departmental objectives.
• Facing internal and external audits, ensuring highest level of compliance for cGMP and EHS norms

Key Responsibilities

• Scheduling, planning, executing, monitoring and control of shift based manufacturing operations.
• Responsible for the Upstream operations for the manufacturing of cell culture processes & Inoculum Operations for the production of monoclonal antibodies
• Preparation and review of cGMP documents like SOP, batch records, checklists, protocols and reports.
• Handling of single use bioreactors, good in Asceptic Operations handling.
• Maintaining the equipment and facility in a state of compliance with effective calibration, preventive maintenance and validation programs.
• Organizing workflow by assigning responsibilities and preparing work schedules to meet the production targets.
• Managing and mentoring a small group of experienced employees for downstream operations.
• Analysing and resolving equipment, process and operational problems in an effective and timely manner.
• Coordinating with cross functional teams for the smooth functioning of operations to achieve the departmental objectives.
• Facing internal and external audits, ensuring highest level of compliance for cGMP and EHS norms

Educational Qualifications
Required Education Qualification: B.Tech
Required Experience: 0 - 7 years