Summary
Overview
Work History
Education
Skills
Instrument Handling
Significant Professional Achievements
Strength And Attitude
Documentation
Disclaimer
Timeline
Generic
Neeraj Verma

Neeraj Verma

Ahmedabad

Summary

Specialist in Downstream Processing with a robust background in protein extraction from Mammalian, Microbial, Yeast, and Hybridoma cells. Notable achievements include optimizing processes for increased protein yield and maintaining strict adherence to regulatory standards. Expertise in statistical analysis and teamwork drives advancements in biopharmaceutical development.

Overview

17
17
years of professional experience

Work History

AGM Downstream, Biosimilars

Kashiv Biosciences
Ahmedabad
01.2023 - Current
  • Managed microbial and mammalian projects, driving innovation in protein development.
  • Improved yield of microbial protein through effective process intensification techniques.
  • Addressed FDA queries related to microbial processes, supporting regulatory compliance.
  • Coordinated technology transfer of a microbial project to a CRO for enhanced efficiency.
  • Established robust processes for Fab proteins, focusing on consistency across batches.
  • Scheduled batches meticulously to ensure uniformity in production outputs.
  • Planned scale-up operations for Fab molecule production up to 200 L.

MSAT Specialist

Dr. Reddy's Lab
Hyderabad
05.2022 - 12.2022
  • Prepared process scale-up documents to ensure manufacturing readiness.
  • Facilitated technology transfer to manufacturing to enhance operational efficiency.
  • Resolved large-scale challenges by identifying root causes and implementing solutions.
  • Coordinated with cross-functional teams to address manufacturing-related issues quickly.

Research Scientist

lupin Biotech R&D Division
Pune
09.2014 - 04.2022
  • Conducted research on two proteins derived from microbial and mammalian cells.
  • Enhanced process intensification and yield for one microbial protein.
  • Executed scale-down model qualification and conducted risk assessment using FMEA.
  • Identified critical process parameters and established design space for robust manufacturing.
  • Performed multivariate DOE studies and statistical analysis with Design Expert and JMP.
  • Developed reports and recommendations based on research findings.
  • Characterized processes and prepared documentation for microbial and mammalian products.
  • Coordinated with vendors to optimize lab operations through effective procurement.

Bioprocess Specialist

Pall Life Sciences
New Delhi
03.2013 - 09.2014
  • Performed filtration trials for biosimilar protein and ophthalmic, oral drugs at client sites.
  • Collaborated with team to expand business opportunities effectively.

Research Associate

Zydus Research Centre (ZRC)
Ahmedabad
04.2008 - 03.2013
  • Attained experience in protein purification for various cell types including bacterial, mammalian, yeast, and hybridoma.
  • Gain knowledge about analytical techniques essential for optimizing protein purification procedures.
  • Engineered end-to-end production process for innovative monoclonal antibody cocktails.

Education

M. Tech. - Biotechnology

M.I.T.S.
Gwalior
01.2007

M. Sc. - Biotechnology

C.S.J.M.U.
Kanpur
01.2005

B.Sc. - Chemistry, Zoology

Government Degree College
Sitapur
01.2001

12th -

UP Board
Allahabad
01.1997

10th - Science

Government High School
Sitapur
01.1995

Skills

  • Process improvement strategies
  • Technology scaling and transfer
  • Risk evaluation techniques
  • Statistical methods for analysis
  • Project planning and execution
  • Collaborative teamwork skills

Instrument Handling

  • Series of AKTA systems (AKTA Pilot, Purifier, Explorer, Basic, Prime)
  • Centrifuge (Batch and continuous)
  • Cell disrupter
  • Spectrophotometer
  • TFF system (Cassettes & Hollow fibers)
  • Gel Doc
  • Rotavapour & gel units
  • Vertical gel electrophoresis
  • Isoelectric focusing (IEF)
  • Western blotting
  • Protein estimation
  • Peptide mapping

Significant Professional Achievements

  • Developed a robust and consistent end to end process for a Novel mab cocktail at Zydus Research Centre.
  • Significant yield improvement in ranibizumab process at Lupin.
  • Resolved manufacturing challenges at pegylation step in GCSF.
  • Yield Improvement in GCSF process at Kashiv.
  • Developed a robust and consistent end to end of process for a challenging Fab molecule.
  • Awarded with employee of the month & Bravo as appreciation for process development in short period.
  • Visited Bangladesh to resolve the issue in vaccine purification with major biotech company.
  • Taken Preclinical batches of different MAbs for DBT Submission.
  • Taken Clinical Trial batches of different MAbs in GMP facility.
  • Qualified Graduate Aptitude Test in Engineering (GATE) examination in year 2004 (91.65%, AIR 395).

Strength And Attitude

  • Good communication, technical, analytical and problem solving skills.
  • Consistent in maintaining positive attitude, sense of responsibility, harmony and effective work culture with people of different backgrounds and temperaments.
  • Management of Lab Activities (Inventory of Resins, chromatography columns & TFF cassettes).
  • Skillful in managing time, prioritizing tasks, meeting deadlines and in producing quality work.
  • Ability to handle high pressure situations in a calm manner and a good listener.

Documentation

  • Preparation of protocols, Process development report, Scaledown model qualification protocols and reports, SPR’s, BMR’s, study reports and Technology Transfer document (TTD), to conduct the studies, investigation reports and review of critical documents for regulatory submission.
  • Preparation of URS, SOP’s and equipment qualification documents.

Disclaimer

I hereby certify that all the information provided above is true to the best of my knowledge and belief.

Neeraj Verma

Ahmedabad

Timeline

AGM Downstream, Biosimilars

Kashiv Biosciences
01.2023 - Current

MSAT Specialist

Dr. Reddy's Lab
05.2022 - 12.2022

Research Scientist

lupin Biotech R&D Division
09.2014 - 04.2022

Bioprocess Specialist

Pall Life Sciences
03.2013 - 09.2014

Research Associate

Zydus Research Centre (ZRC)
04.2008 - 03.2013

M. Tech. - Biotechnology

M.I.T.S.

M. Sc. - Biotechnology

C.S.J.M.U.

B.Sc. - Chemistry, Zoology

Government Degree College

12th -

UP Board

10th - Science

Government High School
Neeraj Verma