Job Requirements:

• Academic Qualification: Post-graduation in Life science or Chemical Engineer
• Relevant Experience: 15 + years in Biologics Manufacturing
• Technical Skills/Knowledge: Experience of Biologic Manufacturing in Life sciences industry

• Cell Culture/Fermentation: Oversee the growth of cells or microorganisms in bioreactors, optimizing conditions for maximum yield.
• Process Knowledge: Manage purification and isolation processes to extract and refine the biologic product. Good process and operational knowledge on Upstream, Downstream, Clean Utility and aseptic technology
• Equipment Monitoring: Supervise the operation of specialized equipment used in biologics manufacturing. Hands on experience on SS Fermenter, Single used Bioreactor, Disposable bags and aseptic operations. Execute and optimize cell culture or fermentation processes using state- of-the-art bioreactors. Oversee the growth of cells or microorganisms in bioreactors, optimizing conditions for maximum yield. Apply stringent aseptic techniques throughout manufacturing processes to ensure product integrity.
• Process Optimization: Continuously improve manufacturing processes to enhance efficiency and yield. Protocol Preparation & execution of Process validation, cleaning validation and establishment of hold time studies.
• Documentation: Maintain accurate records and documentation in compliance with regulatory requirements. Documentation experience of preparing SOP, BMR, Process Checklist, Deviation logging, CAPA writing, etc.,
• Collaboration: Work closely with cross-functional teams, including research and development, quality assurance, and regulatory affairs.
• Compliance: Ensure adherence to Good Manufacturing Practices (GMP) and other regulatory guidelines.
• Troubleshooting: Address any deviations or issues during manufacturing, implementing corrective actions as needed.
• Technology Transfer: Facilitate the transfer of new processes or technologies from development to manufacturing.
• Training: Provide training to manufacturing staff on processes, safety protocols, and compliance requirements.
• Responsible for executing commercial manufacturing of Biological Drug substance batches for local & regulatory markets. Experience in facing Regulatory, local and client audits