Job Role: Section Head – USP Production
Designation: Manager / Senior ManagerExperience: 12 to 18 Years
Qualification: B.Tech / M.Tech
Job Profile:
- Must have worked in Drug Substance of recombinant therapeutics
- Must have experience of handling mammalian cells for production of bio-therapeutics, preferably monoclonal antibodies (mAbs) and must have worked on large scale bioreactors (at least 1000-L capacity bioreactor), preferably of stainless steel.
- Must have experience in the hands-on operations of Bioreactors and troubleshooting in the process. The person should have knowledge of issues such as bacterial, fungal, and viral contamination especially at large scale cell culture operations.
- Should have a thorough knowledge of continuous centrifugation (disc-stack) & also of secondary clarification techniques such as depth filtration.
- For above positions, the candidates are expected to have understanding of regulatory requirements, such as licenses needed for manufacturing and testing, process and cleaning validations, and Post-approval changes. Must have knowledge of QMS documentation, e.g. CAPA, change control, deviation & RCA.
- An ideal candidate should have experience of leading a team of more than 10 persons. He should have the experience of more than 6 years (of working in biotech plant).
- The person should have thorough knowledge of all the manufacturing operations of Biosimilar Products like Adalimumab, Bevacizumab, Rituximab, and Trastuzumab.
Preference will be given to those candidates who have with above mentioned requirements. The relevant candidates should submit their CVs based on the mentioned code no. along with current and expected CTC to ruchi.lal@zyduslife.com by on or before 15th February 2023.
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