Biopharmaceutical Consultant: cGMP Process Development, Fermentation and Purification of Biologics

Technical Consultant #1694


Expertise

  • Over thirteen years in the life science industry with more than ten years of downstream process development, technology transfer and cGMP experience for combined biopharmaceutical, in vitro diagnostics and medical device industry.
  • In depth experience in finding and implementing practical solutions to both midstream and downstream processes.
  • Four years of hands on experience working in the clean room environment, witnessing and troubleshooting the processes, data analysis and quality oversight within a highly regulated cGMP manufacturing environment.
  • Four years of hands on experience in a contract manufacturing environment for the production of recombinant proteins for human clinical applications.
  • Process development for GMP biologics contract manufacturer to provided mammalian cell culture and microbial fermentation services for the production of protein therapeutics for pre-clinical to Phase III human trials
  • Contributed to the cGMP production of eleven products out of which five are now commercially manufactured.
  • Authored and reviewed cGMP documents for accuracy, process flow and manufacturing procedures.

Experience

Independent Consultant, Present

Undisclosed Company, Senior Scientist, 2009 - 2010

  • Downstream process development and manufacturing of a U.S.A. based leading company in contract biopharmaceutical development.
  • Partnering with its clients in developing products efficiently, doing process development, cGMP manufacturing, analytical and formulation development.
  • Planning and execution of downstream process development, scale-up, technology transfer and manufacture of recombinant proteins from both mammalian and microbial hosts for phase I-II human clinical studies.
  • Guidance and supervision of junior staff to accomplish successful execution of client projects on time and on budget.
  • Supporting Business Development department in scope of work, management in identifying system gaps, proposing solutions to improve downstream capabilities and systems.
  • Completed technology transfer, scale-up, and cGMP manufacturing project on tight time line.

QSV Biologics Ltd., Edmonton Alberta Canada, Senior Scientist, 2006 - 2009

  • Downstream process development of an international GMP biologics contract manufacturer which provided mammalian cell culture and microbial fermentation services for the production of protein therapeutics for pre-clinical to Phase III human trials and early commercial supply.
  • Planned, managed and executed downstream process development, scale-up, and technology transfer of recombinant proteins for cGMP manufacturing of phase I-III clinical materials.
  • Completed seven downstream projects in three years. Built and supervised team of scientists and worked with cross functional teams on scope of work and ultimately responsible for all downstream responsibilities related to manufacturing services.
  • Acted as a point of contact for all process related communications with clients and internal cross-functional teams.
  • Represented company as downstream process expert during new prospect meetings.

Bio-Rad Laboratories, Hercules, CA, Staff Scientist, 2001 - 2006

  • Scientist for a clinical diagnostics group which delivered a broad range of technologies used to detect, identify, and quantify substances in bodily fluids and tissues for supporting medical diagnosis, detection, evaluation, and the monitoring and treatment of diseases and other medical conditions.
  • Designed, developed, optimized, and transferred purification processes for the manufacture of three critical biological materials, which are now part of FDA cleared IVD products (Chromatin, Heterophile, and Goat anti human IgG) used with BioPlex2200 Immunoassay analyzer platform.
  • Resolved performance issues of the solid phase immunoassays for development scientists by analytical characterization of about 15 commercial antigens and developing purification strategies.
  • Presented data regularly on the project developments at business unit's quarterly meetings to crossfunctional teams.

Allergan Inc., Fremont, CA, Process Development Scientist, 2000 - 2001

  • Process development for a multi-specialty health care company focused on the discovery, development and commercialized of innovative pharmaceuticals, biologics and medical devices.
  • Participated in downstream process development and scale-up of an injectable protein that now has FDA approval as commercial products, CosmoDermâ„¢ and CosmoPlastâ„¢ human-based collagen.
  • Optimized and scaled-up depth filtration, membrane chromatographic steps, as well as tangential flow filtration steps for the new process for cGMP manufacturing.
  • Supported the start-up of manufacturing facility for human collagen purification.

BD Biosciences, San Jose, CA, Manufacturing Chemist, 2000

  • Plant chemist for a global medical technology company manufacturing medical supplies, medical devices, laboratory instruments, antibodies, reagents and diagnostic products.
  • Purified monoclonal antibodies from serum / ascites fluid and cell culture supernatant by serum fractionation and column chromatographic techniques (ion exchange, HIC, affinity chromatography) under cGMP environment.
  • Developed and validated methods for antibody purification.

Baxter Healthcare Corporation, Duarte, CA, Biochemist, 1998 - 2000

  • Biochemist working for the development and manufacture of medical supplies, devices, laboratory instruments, antibodies, reagents and diagnostic products.
  • Planned and executed experiments in support of technology development for therapeutic proteins.
  • Supported research program involving a number of complicated protein analytical procedures.

Honors & Publications

Credentials

  • BioProcess International Biopharmaceutical Training Conference, North Carolina
  • Colors Personality Training, Canada

Education

  • Ph.D. Biochemistry, Basic Sciences and Humanities, Punjab Agricultural University, India
  • M.S. Biochemistry, (Honors) Basic Sciences and Humanities, Punjab Agricultural University, India
  • B.S. Biochemistry, (Honors) Basic Sciences and Humanities, Punjab Agricultural University, India
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