Opportunities for the position of "Section Head - DSP" Production of Zydus Biologics, Biotech Park, Ahmedabad.
Job Role: Section Head - DSP Production
Designation: Manager/Senior Manager
Experience: 12 to 18 Years
Qualification: M.Sc Biotech/B.Tech/M.Tech
Job Profile:
1. Must have experience of working on large scale chromatography system and columns (hands-on experience of operating AKTA systems, Axichrom and Chromaflow columns)
2. Must have experience and technical knowledge of packing and unpacking of large capacity columns, and operating large scale TFF systems (preferably 30 Sq. meters and above)
3. Must have the knowledge of scale up of chromatography and TFF
operations and the challenges associated with.
4. Must have thorough knowledge of different filtration techniques including Nano-filtration and hollow fiber-based filtration and analysis of data generated in the batch including analytical data.
5. Must have knowledge of Upkeep/Maintenance of Chromatography
systems, Columns, Chromatography Media, TFF systems, TFF
membranes.
The person should have the thorough knowledge of large-scale volume buffer preparation, which are used for purification operations and should be aware of CEHT and DEHT.
For above position, 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.
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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.
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Preference will be given to those candidates who have with above mentioned requirements. The relevant candidates should submit their CVs along with current and expected CTC