Ajim Shaikh
Biosimilar manufacturing Expert ||MES PAS-X II Downstream Processing Professional || Mammalian cell culture || Production Specialist at Dr. Reddy\'s Laboratories
- Role
- Production Specialist at Dr. Reddy's Laboratories
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Ajim Shaikh
I am a biotechnology professional transitioning into Computer System Validation (CSV) and…
Experience
Production Specialist
Jul 2021 — Present · Hyderabad, IN
Large scale mammalian Cell Culture: Perform downstream processing of biologics like Rituximab and Bevacizumab in a large-scale environment.Chromatography Processes: Operate and optimize various chromatography techniques including affinity, anion, and cation exchange chromatography.AKTA Systems: Manage operations on AKTA process systems (25 mm and 10 mm, Cytiva) and ensure optimal performance.Column Packing and Unpacking: expertise in column packing, unpacking, and column qualification.Filtration Systems: Expertise in Tangential Flow Filtration for separation and concentration processes.CIP, PHT, SIP & FIT: Lead cleaning-in-place (CIP), post-harvest treatment (PHT), sterilization-in-place (SIP), and filter integrity testing (FIT) operations to ensure quality and compliance.Process Qualification: Successfully execute Process Performance Qualification (PPQ) batches, particularly for Rituximab.Manufacturing Execution System (MES): Expertise in Werum PAS-X MES suite for process control, monitoring, and batch execution of Bevacizumab.MBR and Batch Release: Submit Manufacturing Batch Records (MBR) and responsible for batch release activities in compliance with regulatory requirements.
Education
M.G.M's Jawaharlal Nehru College of Engineering
Bachelor of Engineering - BE, Biotechnology
2011 — 2015
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