Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
LANGUAGE
Training
Instrumentation Experience
INTEREST
Timeline
Generic

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 Pradesh
07.2022

BSc - Microbiology

Vidyasagar University
Medinipur, WB
05.2018

PhD Part-time - Biotechnology

Karunya Institute of Technology And Science
Coimbatore, India
12-2029

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

Similar Profiles

CREATE PROFILE
Kousik Kar