Vinodh Kumar

About Vinodh Kumar

About me:Researcher motivated in advancing the downstream process development and characterization of therapeutic mAbs. Currently spearheading the spectrum of CMC activities for Biosimilar mAb in Biocon Biologics. With over a decade of experience in bioprocessing, I possess hands-on expertise spanning from clone development to sophisticated purification techniques. My commitment to excellence is demonstrated through a track record of successfully navigating diverse challenges in the field and a continued passion for embracing new opportunities.Research Highlights:• Developed and established a cost-effective platform for high throughput clone screening using an automated liquid handling system for accelerating biosimilar process development.• Successfully optimised process for managing aggregates in a biosimilar mAbs’ purification.• Developed methods to sort out the stem cell population in clinical cancer samples.• Successfully demonstrated gene knockdown and genetic modification in human cell lines and marine algae respectively.• Developed and patented the bioprocess for increasing biomass for RIL.• Created trade secrets for culturing techniques for industrial producer strain.

Experience

1. Associate Scientific Manager i

   Biocon Biologics

   Oct 2024 — Present · Chennai, IN

   Strategic Planning and Execution:Spearheading R&D downstream activities for process development and characterization of a Biosimilar mAbs, emphasizing optimal resource utilization for enhanced operational efficiency.2. Innovation and Technological Evaluation:Conduct vendor trials, evaluate new technologies as part of CoE for high-throughput clone screening and filtration. Engage in SAP activities related to process orders and raw material management.3. Mentoring and Supervision:Supervise and train new team members on LIMS-eLN, DSP techniques and GLP compliances, guidance to interns for their projects and managing a focused team.4. Tech Transfer for At-Scale Operations:Lead downstream process tech transfer from lab and pilot scale to manufacturing scale, including preparation and execution of transfer protocols, process comparability assessments, scale-up justification, and on-site support to ensure robust and reproducible commercial operations.5. Process Characterization Studies:Design and execute downstream process characterization studies to identify critical process parameters (CPPs) and their impact on critical quality attributes (CQAs), supporting process understanding, robustness, and regulatory expectations through DoE-based approaches.6. Virus Validation Studies:Plan, coordinate, and support viral clearance validation studies for downstream unit operations, including chromatography and filtration steps, in collaboration with external CROs, ensuring compliance with regulatory guidelines and alignment with overall control strategy.

Education

• Indira Gandhi National Open University

  Masters in Law (Intellectual Property), Patents, Copyrights, Trademark, Data exclusivity, Generics, Biosimilars, Super Generics

  2014 — 2016

• Birla Institute of Technology and Science, Pilani

  Master of Technology - MTech, Pharmaceutical Operations and Management

• Birla Institute of Technology and Science, Pilani

  Doctor of Philosophy - PhD, Medicinal and Pharmaceutical Chemistry

• Bharathiar University

  Bachelor of Science (BSc), Biotechnology

  2006 — 2009

• Madurai Kamaraj University

  Master of Science (MSc), Microbial Gene Technology

  2009 — 2011

• Indian Institute of Management Bangalore

  6 week - Certificate course, Innovation Management

• Centre of Excellence

  Diploma in Epigenetics, Genomics

  2020

• Anna University Chennai

  Master of Business Administration (M.B.A.), Biotechnology

  2011

Skills

• Recombinant Dna Technology
• Molecular Biology
• Genome Editing
• Western Blotting
• Regulatory Affairs
• Protein Expression
• Immunohistochemistry
• Cancer Research
• Pcr
• Cell Culture
• Bioinformatics
• Biotechnology Industry
• Southern Blot
• Molecular Cloning
• Project Management
• Bacterial Transformation
• Algal Biotechnology
• Facs
• Genetics
• Genomics
• Transfection
• Recombinant Dna
• Molecular Characterization
• Next Generation Fuels
• Dna