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Ph.D. Vaccines Process Development and Manufacturing Expert. Biotechnology: Delivering Facility Designs, Layouts, Planning in Vaccine Development and Manufacturing

Technical Consultant #2552


Expertise

Industrial Biotechnology 

  • Biotechnology facility design and layout, overall planning, project conception, budgeting and execution. 
  • Over twenty tears of industrial experience in-process development of vaccines and biologicals in leading companies.  
  • Research and development biotechnology management and transfer.
  • Process development and optimization for bacterial vaccines. 
  • Vaccine’s manufacturing unit layout and infrastructure development.
  • Cell culture development.
  • Downstream and filtration technology.
  • Research Grant proposals for funding agencies.
  • Proven track record in CGMP - Current Good Manufacturing Practice regulations manufacturing and development of vaccines and biologics including:  Technology Transfer, Scale Up, Process Optimization, Formulation Development and Process Analytical Development. 
  • Well versed with GLP, cGMP and other regulatory guidelines specific for biologics development.
  • Design layout and infrastructure for facility manufacturing block.
  • Handle specifications finalization, vendor selection based on tender, FAT, SAT, IQ/OQ/PQ for process equipment.
  • Experience in facing audits from prospective clients as well as regulatory agencies. 
  • Experienced Liaison with regulatory bodies, International institutions like WHO, Industry bodies, i.e., DCVMN and funding organizations.
  • Price negotiation skills.
  • Use of animals for evaluating the efficacy of developed intermediates, drug substance and final product.
  • Patent prior art search and drafting.
  • Preparation and evaluation of technical proposals; budget preparation. 

Academic: Teaching and Research 

  • Experience in academic research related to diabetes mellitus and atherosclerosis in animal models. 
  • Grant writing and winning.
  • Mentoring candidates in their research towards obtaining graduate or doctoral degree. 

Experience

Independent Consultant, 2018 - Present

  • Independent Consultant for Biologics.             

HLL Biotech Ltd., (A Govt. of India Enterprise), Technical Advisor2017 - 2018

  • As Leader of manufacturing team for establishment of facility for the production of HIB, BCG, HepatitisB and pentavalent vaccines.  

Head of Bacterial Vaccination Manufacturing2017

  • Process development of HIB and BCG vaccines. 
  • Formulation development of Pentavalent vaccine.
  • Analytical development assays in co-ordination with quality control.
  • Technology transfer process discussions and implementation.
  • Team member in technology transfer of Hepatitis B vaccine at scale-to-scale level.
  • Experience in conducting technical due diligence activities for transfer of Technologies.
  • Project planning and execution (layout design of manufacturing facility, URS for equipment, budget,) for the Integrated Vaccines Complex (IVC) getting set up by Govt. of India.
  • Participation in the pre-bid, tender opening, technical review, financial bid opening, price negotiation and subcommittee meetings.

Green Signal BioPharma Pvt. Ltd., Chennai, India, Head, Plant Operations2009 - 2013  

  • Responsible for manufacturing and quality operations of BCG vaccine and BCG ONCO (for therapy of superficial bladder cancer) under cGMP environment.
  • Involved in production, testing (including animals), validation and regulatory compliance. 
  • Identified areas of improvement to enhance operational efficiencies of machine  and equipment.
  • Responsible for the execution of vaccine supply to Government of India under their EPI program. 
  • Participated in preparation of prequalification document submitted to WHO (World Health Organization). 

Transgene Biotek Limited, Hyderabad, India, Head, Process Development2008 - 2009

VINS Bioproducts Limited, Hyderabad, India, General Manager, R & D2007

  • Setting up laboratory for the process development of therapeutic proteins from snake venoms. 

Biological. E. Ltd., (AGM Cadre), Hyderabad, India, Senior Scientific Officer, 2003 – 2007

  • Group leader responsible for Development of Haemophilus influenzae type b vaccine and quality control assays development.    
  • Scale-up to manufacturing. 

Bharat Biotech International Limited, Hyderabad, India, Senior Scientist1999 - 2003

  • Successfully developed the process of fermentation, isolation, purification and formulation of recombinant human epidermal growth factor (rhEGF) for therapeutic use.
  • Developed in-process quality control and release assays in the malaria vaccine (PvRII protein) project in collaboration with ICGEB, New Delhi. 

Educator 

  • University of Hyderabad Teaching Intellectual Property Rights topics to class of M.Sc. Medical Biotechnology
  • Clinical Assistant Professor (Research), Department of Pathology, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada 
  • Teaching and  training graduate students in their research projects.
  • Assistant Professor, Islamiah College, Vaniyambadi, Tamil Nadu, India, Teaching undergraduate biochemistry class.
  • Teaching at Shrine Velankanni Higher Secondary School, Chennaifor classes 9 to12 (CBSE)
  • Guided candidates in their MS course during my tenure in the faculty at Universityof Saskatchewan, Canada.
  • Guided doctoral student at University of Saskat.

Honors & Publications


Credentials 

  • Department of Pathology, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.  Role of reactive oxygen species and evaluation of dietary antioxidants in the amelioration of diabetes mellitus and atherosclerosis in animal models
  • Research Associate, Manitoba Institute of Cell Biology, University of Manitoba, Canada.
  • Department of Biochemistry, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.  Glycogen Metabolism in Diabetic Animals, Protein Kinase C, Insulin Receptor. 
  • Post Graduate Diploma in Planning and Project Management, University of Hyderabad, India
  • Post Graduate Diploma in Patent Law, NALSAR, Hyderabad,  

Languages 

  • English (Proficient in reading, writing and speaking)
  • Hindi (Proficient in reading, writing and speaking)
  • Telugu (Proficient in reading, writing and speaking)
  • Tamil (Moderate in writing and reading, proficient in speaking) 

Awards

  • University Grants Commission, Dept. of Biochemistry,Univ. of Madras, Doctoral fellow  
  • Postdoctoral fellow, Dept. Of Biochemistry, Univ. of Saskatchewan, Saskatoon, Canada (Received Medical Research Council of Canada fellowship) 
  • Postdoctoral fellow,Dept. Of Pathology, Univ. of Saskatchewan, Saskatoon, Canada, (Received Heart and Stroke of Saskatchewan fellowship) 
  • Recipient of Biomedical Research Grant of Health Services Utilization and Research Commission, Saskatchewan, for the work on ‘Vitamin E in the retardation of Type II diabetes mellitus’ 

Publications 

  • Author of peer reviewed journals, research documents, a Speaker, and Oral Presenter, (Posters, over 25 publications). 
  • Peer reviewed articles in international journals. Research findings on the mechanism of action of dietary constituents in experimental atherosclerosis and Type 1 and 2 diabetes.
  • Literature search using PubMed, Google Scholar, Research Gate.
  • Patent Search.
  • Writing original research articles, review articles on diabetes and atherosclerosis; vaccines development.
  • Peer-review of manuscripts written by other writers to ensure quality standards are met.
  • Preparing responses to reviewers and peer-reviewers and journal editors’ comments.
  • Reviewed Canadian Diabetes Research Association Biomedical Research Grants.
  • 3 vaccines publications.
  • Over 20 academia publications in Diabetes and Atherosclerosis.

Poster and Presentations 

  • Preparation and presentation (Oral and poster of 75 count) of the research findings at Conferences and Symposiums organized by National and International Professional Organization.
  • Invited speaker to lecture on Biotechnology topics.

Education

  • Ph.D.    Biochemistry, University of Madras, Tamil Nadu, India
  •  M.Phil. Biochemistry, University of Madras, Tamil Nadu, India
  •  M.Sc.    Biochemistry, Andhra University, Andhra Pradesh, India
  •  B.Sc.    Chemistry (Major), University of Madras, Tamil Nadu, India    
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