Bcil Trainee
Bangalore Biotech Labs Pvt. Ltd. (Biozeen)
Bangalore
• CIP, SIP (ESIP & FSIP) of process vessels (Bioreactors, Fermentors, MPVs, upto 125 ltrs), Filter Integrity testing (Hydrophillic and hydrophobic), Autoclaving and its validation, Sterile handling and operations• Aerobic, anaerobic and facultative microbial fermentation operations as well as Cell culture (BHK and CHO cell lines with upto 40L scale and perfusion system (ESF)), media filtration, cryopreservation, cell line characterization, inoculum development, seeding, sterile sampling, process run, monitoring, harvesting, experience on manual as well as automated systems (on reactors upto the volumes of 125L)• Bio-Separations – Centrifugation, Filtration (MF, UF, DF in TFF mode), Chromatography (IEC, HIC, GFC, Affinity with AKTA Explorer and AKTA process, Chromaflow, Axichrome)• Understanding of cGMP, SOPs, regulatory guidelines (USFDA and ICH), Process engineering including preparation of Block drawings, URS, GA drawings, Process Flow Digrams, P&IDs, Equipment specifications, Utility requirements, Clean rooms• Equipment /process Qualification and Validation (for specific systems and processes, protocol writing and site executions) including DQ, IQ, OQ, PQ.