Assistant Manager MSAT
Biocon
Total des années d'expérience :13 years, 4 Mois
An immaculately presented, passionate & dynamic Biotechnology engineer possessing extensive experience in
Downstream Manufacturing of Mammalian (Monoclonal Antibodies) as well as Bacterial Downstream (Recombinant
Proteins)
Evaluation and support of implementation of new processes focusing on direct transfers.Technology transfer document
review
-Continuous improvement of processes following the Manufacturing Process Excellence (MPE)
concept.Troubleshooting, Investigation & Root cause analysis, Handling deviations-Investigation, CAPA and its
implementation (Technical aspects)
-Resolving technical issues arising during the Downstream processing of MAbs in coordination with RND;
Downstream process support
Execution, supervision of Mammalian & Microbial Downstream activities for 5 different Monoclonal Antibodies & three
recombinant protein in GMP & EU compliant facilities (2KL & 4KL).
-Handling Downstream Equipments viz; Continuous Centrifuge (Alfa Laval); Chromatography systems (PALL, GE &
Millipore) and Columns (PALL, BPG, BioRad, Quick scale);Tangential Flow Filtration (PALL & Millipore); Viral Filtration
Skid (Millipore); Filling station, Freeze thaw, Biosealer & Biowelder (Sartorious)
-Formulation, Filling & Freezing of Bulk Drug substance
Involved in Cleaning Validation, Technology transfer & Process validation
-Managing the shift comprising of 4-5 operators as a
for Asia region to provide technical support on Plant scale Column Packing (A key member in the biggest
& Automated column installation and functional qualification of AutoPak 2000 mm SS columns-Successfully completed).
-Engage in SLS India activities and programs. Working with continuous processing applications at Pall-Bio SMB, AWS, ILC.
-Provide technical guidance and reports on Integrity testing, sterilization and other applications involved during sterile
filtration of DS & DP.
-Global exposure in dealing with Customers for their filtration and Chromatography column requirements, technical
solutions and troubleshooting the downstream applications.
-Provide detailed training to customers. Provide Global Tech Support to PALL customers. In charge of Center of
Excellence-SLS Laboratory (LRQA certified).
-Generating formal technical reports / documents with detailed data analysis and interpretation used for submission to
regulatory authorities such as USFDA, EMA and Rest of World (RoW)
-Supporting Biopharma customers and key stake holders aligned to line of business at PALL
-Pre-sales evaluation of PALL products for customer processes, conduct trials, validations, & trainings on products to
demonstrate value to customers.
-Managing activities in PALL Lab and provide logistic support if required.
-Comply with EHS, ethical practices, ISO activities and related quality programs. Closure of POR and troubleshooting
customers cases in a timely manner