Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics’ portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan.
Cell Cuture Process, Fermentation activities, Enaculum Operations
Job Description:
Biosimilar Manufacturing Upstream– mAbs
Responsibility
· 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.
Requirements
· Graduate/Post graduate in life sciences with 10+ years of experience
· Experience in large scale bioreactors of biologicals for commercial and clinical requirements
· Good communication and interpersonal skills
· Problem solving skills, highly motivated with a results driven approach
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