Job Description
Job Responsibility and key Decisions
To lead the Downstream manufacturing team and oversee implementation of production schedules.
Producing mammalian cell culture products Biosimilars in defined terms of volumes and timelines, while ensuring compliance to quality standards, GMP and other regulatory and statutory requirements, as per schedule.
Mandatory to have cGMP and knowledge of safety. Quality Systems For Downstream Chromatography, TFF, various filtration operation and using inbuilt control and data acquisition and storage systems, data verification and evaluation for batch consistency monitoring.
Understanding of process manufacturing at different scales of downstream operations. Quality Systems and regulatory environment. Lead a team having good leadership and mentoring capabilities.
Complete PMS management for team.