Kousik Kar
Bankura
Summary
Accomplished Production Specialist with a strong background in mammalian cell culture, cell banking, and single-use bioreactors, consistently enhancing monoclonal antibody production processes. Expertise in collaboration and innovation, complemented by proficiency in designing MES-PASX eBMR systems. A proven track record of driving continuous improvement initiatives and successfully achieving project milestones underscores a commitment to operational excellence. Passionate about leveraging technical skills to contribute to cutting-edge biopharmaceutical advancements.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Production Specialist
Dr Reddy’s Biologics
12.2023 - Current
- Working In Cell Culture Production of Monoclonal Antibody and Recombinant Protein.
- Primary Responsibility of Establishment and maintaining all necessary cells bank related to production and CDMO.
- Experienced of Preparation of Research cell bank, Master cell bank, Working cell bank and End of Production cell Bank.
- Maintained, passaged, and cryopreserving cell cultures, working side by side with R&D to design and develop new procedures and testing assays.
- Working proactively for continuous improvement in protocols and procedures to boost projects.
- Experience in handling Multiple products like Rituximab, Abatacept, Adalimumab and Bevacizumab, Darbepoetin-Alpha, Trastuzumab, PEG-GCSF etc.
- Experience of establishing new Gen CAR-T molecule, its scale up and bank characterization.
- Specialized in mammalian and microbial cell culture.
- Responsible for preparation, Writing and Revising of Master Formula Record, Master Batch Record, Reports, SOPs, Risk assessments, quality documents etc.
- Actively Prepared cell bank related documentations like Establishment report, Re-release Reports, Re-Qualification Reports, Consistency reports etc in Dochub softwere.
- Experience of eBMR designing by PAS-X software for cell banking eBMR integration project.
- Led MES implementation for PAS|X at the manufacturing site.
- Designed manufacturing processes using PAS|X in the biopharmaceutical industry.
- Designed Manufacturing Batch Records (MBRs) and parameterized Master Batch
Records (PMBRs) for new and site transfer products. - Created parameters and parameterized value lists in PAS|X, mapping them with PMBR.
- Designed ESPs in PAS|X based on equipment functions and manual formats.
- Utilized Cx Administration to fetch values from one MBR to another by assigning them to
either equipment or material. - Created and managed state diagrams (states, activities) based on requirements
- Deviation and CAPA management by DCMS application.
- Responsible for minor Activities like Media Preparation for Cultures, Buffer Preparation, Autoclave Handling, Equipment Monitoring, Vial Issuance, Area Readiness etc.
- Preparation of Samples from Bulk harvest of DS Cell culture for Biosafety testing.
- Media and Cell Culture Quality analyzer by BGA and NOVA Flex 2 analysis.
- Stock maintenance by SAP.
- Secondary Responsibility of Small-scale cell culture Upscaling of mAB Production up to 5L stage.
- Experience of handling multiple products as per Processes.
- Performed cell culture processes in cGMP cleanrooms and development labs using Shake flasks, Baffled Flask, Spinners, Glass reactors and Wave Bioreactors on a daily basis.
- Experienced in basic cell culture operation like via thaw, revival, passage and up-scaling, Sterile Sampling etc.
- Responsible for minor Activities like Media Preparation for Cultures, Buffer Preparation, Autoclave Handling, Equipment Monitoring, Vial Issuance, Area Readiness etc.
- Operation and Calibration of Single Use, Electrochemical pH Probes and DO Probes.
- Responsible for review and submission of BMR.
- Batch data maintained by Process pad.
- Collaborated with cross-functional teams to streamline production processes and minimize downtime.
- Trained new staff on standard operating procedures and best practices in biologics manufacturing.
Junior Officer
Hetero Biopharma
10.2022 - 11.2023
- Worked in Production in Upstream processing of Monoclonal Antibody Drug Substance
- Responsible for Vial Revival from Cell bank, Cell Culturing, Upscaling it up to 2000L bioreactor, Sterile Sampling, Seeding, Feeding, Clarification.
- Media Preparation for Cultures, Buffer Preparation, Feed Preparation.
- Experience in Multi product Activities like Rituximab, Adalimumab and Bevacizumab.
- Worked with Thermofisher, GE and Sartorius stedim small scale and large scale Single Use Bioreactors (20/50L wave reactors, 200L, 1000L and 2000L Single Use Bioreactor).
- Operation and Calibration of Single Use, Electrochemical pH Probes and DO Probes.
- Responsible for Executing Filter Integrity of Media and Feed after Post Filtrations.
- Responsible For Cell Culture Clarification Using Depth Filtrations.
- Batch to batch Performance Monitoring and Stability studies.
- Responsible for Following cGMP And GDP In Facility and matches the compliance level.
Education
MSc - Biotechnology
Shoolini University
Solan, Himachal Pradesh07.2022
BSc - Microbiology
Vidyasagar University
Medinipur, WB05.2018
PhD Part-time - Biotechnology
Karunya Institute of Technology And Science
Coimbatore, India12-2029
Skills
- Mammalian cell culture
- Monoclonal Antibody
- Vial Revival
- Single Use bioreactors
- MES- PASX eBMR Recipe author
- SAP
- Microsoft office
- Cell Banking
- Bank Characterization
- Deviation and Capa Management
- Small Scale cell culture
Accomplishments
- Worked as a trainee in their research wing NSEC- National Salmonella and Escherichia center.
- Trained in pathogenic bacteria isolation Working on bacteriophages as Suitable alternative against multidrug resistant Salmonella typhi, Para typhi and E. coli.
Certification
- Operation of General Electric and Sartorius stedim Single use Bioreactor (10/2022 - Present)
- Coursera Online Certificate course on Drug Discovery
- Coursera Online certificate course on Industrial Biotechnology
- Coursera Online Certificate on Bioinformatics
LANGUAGE
English: Professional Working Proficiency
Hindi: Full Professional Proficiency
Bangali: Native or Bilingual Proficiency
Training
- Central Research Institute (Kasauli)
- Research Trainee
- 08/2022 - 10/2022, Kasauli HP
- Central government research Institute and WHO cGMP certified research lab established in 1905 currently producing rabies, Tetanus, Diphtheria and Polio Vaccine
Instrumentation Experience
- Control system for single use bioreactors
- Control system for mixing systems
- Single use bioreactors (Sartorius, Cytiva & Thermofisher)
- Sartocheck Integrity Tester
- Bio welder and Sealer
- Depth filter holders (3M)
- Biosafety cabinet (Esco)
- PH meter (Thermo Scientific)
- Conductivity Meter (Thermo Scientific)
- 5L Glass Reactors (Sartorius)
- Vi-Cell Cell Count analyzer (Beckman Coulter)
- Automated vialing Machine (Fill IT)
- Shake Flask, Baffled Flask, Spinner Flask
- Water bath
- Orbital CO2 shaker incubator
- Turbidity meter (Hack)
- Centrifuge (Eppendorf)
- Cryo Storage Vessel (Themo Fisher)
- Spectrophotometer ( Nano Drop)
- Controlled rate Freezer
- Rapid Lab Blood Gas Analyzer
- Nova Profile Flex 2
- Osmometer
- PCR
INTEREST
Travelling, Geo-Politics
Timeline
Production Specialist
Dr Reddy’s Biologics
12.2023 - Current
Junior Officer
Hetero Biopharma
10.2022 - 11.2023
BSc - Microbiology
Vidyasagar University
MSc - Biotechnology
Shoolini University
PhD Part-time - Biotechnology
Karunya Institute of Technology And Science