Dr Sumant Chaubey CV
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Dr. Sumant Chaubey has over 15 years of experience in biopharmaceutical research and development. He has held senior positions at several companies focusing on biosimilars and biologics production. His areas of expertise include upstream and downstream processing, analytical development, quality control and quality assurance, and regulatory affairs for biosimilars and biologics. He has experience managing teams and facilities producing molecules such as recombinant GCSF, EPO, insulin, and monoclonal antibodies.
Dr Sumant Chaubey CV
- 1. Dr Sumant Chaubey Brief CV Residence/personal office : B-338,Suryadarshan Township,Manjhalpur Vadodara-390011 Email: sumant.biopharmaexpert@gmail.com,biotechapi@gmail.com Skype:sumant.chaubey, Mobile : 9898639929 ABOUT MYSELF : High turn out leadership, revival of almost financial dead organization to profitable (i.e BBPL), have track record of out of turn performance at Biozeen(Bangalore),Virchow Biotech(Hyderabad) and MTR-KMS(chennai) for Biosimilar,Biologics development and production. SPECIALIZED AREA : Complete Technical Operation (Upstream, Downstream, BioanalyticalQA, QC,Regulatory) of Biosimilars production (r-GCSF,r-EPO,r-PTH,r-Glargine,r-Insulin,r-UOX,r-L aspariginase,r-Factor VIII,r-tPA,Rituximab Complete Operation of Biologicals Production : Tacrolimus,Sirolimus,Taecoplanin ,Orlistat,Mupirocin POSITION HELD TILL NOW: Total Exp : 15.5 Years CTO & CTO- Bills Biotech Pvt Ltd,Vadodara2.2 Years...Salary(CTC): 25 Lakh + SUV Car GM R&D- Virchow Biotech, Hyderabad1.8 YearsSalary (CTC): 18 Lakh + Car Asst General Manager & Head- Biosimilar & Biologics Operation at Micro therapeutics Research Pvt Ltd, Chennai..2 Years.Salary (CTC) : 14 Lakh + Others Senior Manager & Head Biopharma Process development, consultancy and training for Biologics at Biozeen, Bangalore2.5 YearsSalary (CTC):11 Lakh+ Others Senior Group Leader at Biological R & D (APIs) Concord Biotech Ltd, Ahmedabad 1.7 YearsSalary(CTC): 8.8 Lakh Molecular biologist at Institute of human genetics (molecular diagnostic), Ahemedabad.....1 Year Microbiological Consultant for Gujarat Eco Pvt Ltd, Vadodara (during PhD) Senior Research Fellow UGC meritorious fellowship, M.S. University, Vadodara3 Years Senior Research Scientist - Downstream Process at Intas Biopharma Ltd- Worked on GCSF, PEG-GCSF,EPO, IFN-alpha 2a, IL-2.3.8 Years
- 2. POSITION HELD TILL DATE: Corporate Management & Operation Head: 1. Chief Operating Officer- Bills Biotech ,Vadodara Gujarat- 1st Jan,2014- 15 Dec,2015 Role : Process,Technology, Manpower, Money(CAPEX & OPEX) & Material Management for the production of Lipstatin,Orlistat IH,Orlistat USP and Tacrolimus USP Achievement 250-400 Kg/Month Orlistat production & 20 to 50 Kg tacrolimus production My own business models at BBPL- to develop the process for LIPSTATIN,ORLISTAT Intermediate, and gain market immediately by getting intermediate of some other crucial statin(n-1) and convert it to final API. Developed the revenue model at Bills with market value of 150000USD- 2000000USD per annum Reporting to Chairman Managing 70+ permanent + 150 Contractual technical and non technical staffs 2. Head of R&D & Sr. GM at Virchow Biotech Pvt Ltd,Hyderebad Biosimilar & Biologics Product Portfolios :R&D,Pre clinical & Clinical research,Bioanalytical R&D,QC o rH-GCSF,PEG-GCSF,r-URATE OXIDASE,PEG-UOX,r-INSULIN,r-GLARGINE,r- PTH,r-EK,r-CBP,L-ASPARAGINASE,r-tPA,r-EPO,r-Protein A,Enterokinase My responsibilities: R&D Operation, Technology Transfer, Regulatory approval, PCT, CT etc Reporting directly to MD Managed 40+ scientist,Junior scientist and researchers 3. Asst. General Manager- Biopharma operation at Microtherapeutics Research labs Pvt ltd- (2.2 year ) Development of PTH,Glargine, PegFilgrastim, ,Peg-IFN, hGH, EPO,IFN-alpha 2a, ,NDA, Collobration Opportunity with other Biopharma companies for
- 3. Proceess,Technology,Clone,etc) and also the business model decision for partnership, bulk supplier, quality check, Negotiation, DCGI approvals, Facility audit. Etc, Bioanalytical methods to qualify the Bulk/API supplier for Mabs and proteins. Reporting to CMD Managed 10 scientist + 22 Juniors 4. Sr .Manager & Head - Biosimilar and Biologics Process Development,Research & Training ,consultancy at BiOZEEN (2 Years 6 months) GCSF,EPO,IFN, Hepatitis Vaccine- Process develop, DOE,PAT, Heading Fermentation, cell culture, downstream and biopharma validation lab, Process control, Technical Lookout, R & D lookout, Akta Process, Akta Pilot, Dual Fermentor, CIP station, Wave bioreactor, Axichrome, Chromaflow, ATF-Cell culture,CHO,BHK-21 Business for Biopharma process consultancy & Training, Formulation, GLP, and Validation. Global Business development to attain customer from Korea, Brazil, S.Africa, Canada, Iran. Managed team of 26 members Reporting to CEO/President 5. Senior Group leader Fermentation and Synthesis R & D at Concord Biotech Limited : 2 year 4 months Managed 10-12 members Reporting VP & CMD Tacrolimus,Sirolimus,Statins(Lipstatin,Pravastatin,Lovastatin),Daptomycin,Mica fungin, Moftel phenylic acid- Strain improvement,Media optimization,DOE,PAT etc
- 4. 50 l fermentation,100 L fermentation , HPLC method development for tacrolimus ,sirolimus,lovastatin,other statins,..scale up to 10KL ,20KL FERMENTATION scales 6. Head - Molecular biology and biochemistry lab at Institute of human genetics india, (1.8 months) Real time PCR and normal PCR method development for Muscular dystrophy,Sickle cell,Haemophilia,genetic diseases, and paternity test,maternity test etc Managed 7-8 members 7. Senior Research Scientist - Downstream at Intas Biopharmaceuticals, July 2004 - November 2007 (3 years 5 months) GCSF,PEG GCSF,IFN-2b,IL-2,EPO- Downstream and Protein Purification: Expert in developing methods on AKTA process, AKTA pilot, AKTAexplorer, AKTA Purifier & basic, BPG columns of various scale (R&D to production), Chroma flow column, Axichrome column and packing station handling and operation.Protein purification steps like inclusion body dissolution, refolding of proteins, membrane based microfiltration (TFF-MF,UF and dialysis), DOE (design of experiment certification) for DSP and USP method development on Minitab by SSE solution, Bangalore), authorized to provide the DOE training and certificate, Design of experiment (Minitab, Design expert etc ), Chromatography types - Size exclusion chromatography, affinity chromatography, ion exchange chromatography and hydrophobic interaction chromatography. Method development and programming on AKTA prime, Basic, Purifier and AKTA pilot TECHNICAL EXPERIENCES : R&D-CLONING TO PROCESS DEVELOPMENT,SCALE UP AND BULK PRODUCTION More than 15 years industrial experience on R&D Operation, Technology Transfer, Regulatory approval, PCT, CT and mammalian and E.coli production (Fermentation,
- 5. DSP, Cell culture, Bioanalytical, Formulation, Audits and Regulatory etc),Partnership, NDA, Collobration Opportunity with Biopharma companies from USA and Europe(for Proceess, Technology, Clone). Managerial skill : Experienced for quarter release for projection, expected profit and its distribution, Appraisal and job responsibility matrix creation for maximum output of employees, CAPA, KPI, CAPEX & OPEX , SWOT, Strategic Pertnership and alliance strategy,NDA,CDA preparation, ANDA,DMF,DCGI,USFDA,EUGMP,GLP,GMP audit Business Planning, Setting the long term mission of R&D portfolios. Experience on Business model decision for partnership and held various scientific, technical & managerial senior positions at Virchow Biotech, Intas Biopharma, IHG, Concord biotech, Biozeen- Bangalore Biotech Lab, MTR/KMS biopharma. Managerial activities, Trainings and Corporate presentations: Overall turn over, forecasting, profits, annual budgets- BBPL Presented the financial update, CAPEX and APEX of biosimilar department at MTR annual board meeting in April,2013 Attended and represent the MTR company at Biosimilar-2013 at Mumbai Attended and represented MTR company at Bioasia-2013(Biosimilar & Biologics) at Hyderabad Attended leadership training programme at Bangalore with CEO in year 2012 Worked on process development and production of following molecules e.g. GCSF, Erythropoetin, IFN-2b, IL-2, rH-GCSF,PEG-GCSF,r-URATE OXIDASE,PEG-UOX,r- INSULIN,r-GLARGINE,r-PTH,r-EK,r-CBP,L-ASPARAGINASE,r-tPA,r-EPO,r-Protein A ,& Tacrolimus, Sirolimus, Statins etc. Interaction with Biosimilar & Biologics Co. Global Leaders & Executives at BioAsia January 2013 - January 2013 (1 month): Strategic Partnership, Market potentials,Pipeline and Future Market, Collaboration potential Experience :
- 6. Bioanalytical techniques for Biosimilars & Biologics : IEF,LC- MS,FTIR,CZE,ELISA,RP-HPLC,SEC-HPLC,Proteomics,Peptide Mapping, Protein sequencing, N- terminal sequencing Bioanalytical experiences on rec-GCSF, rec-PEG-GCSF, rec-PTH, rec-UOX, rec- Erythropoetin alpha & Beta, rec- IFN-2a & 2b, retuximab,rec- insulin,rec- glargine,rec-tPA HPLC Experience on method development and validation-More than 5 year ( 4.5 year Ph.D + 3.5 Year Industrial),HPLC Isocratic and gradient, Optimization of mobile phase, selection of column and different kind of detectors, Expert in analytical instrument and process validation and method development following USFDA. Instruments validation exp : UV-Visible spectrophotometer, RP-HPLC (WATER and SHIMADZU), HPLC column performance check and their calibration, Chromatography column and instrument performance check and method development. o Antibiotics(polyketides) bioassay method development: MRSA, E.Coli, Salmonella Spp. >4 years experience(during Ph.D) o Analytical Methods and their result analysis viz. NMR, LC-MS, FT-IR, GC, GC- MS, HP-TLC etc. o Cell culture, Cell banking, Analytical assay validation, ELISA, Immunoelectrophoresis and gel diffusion, SDS PAGE electrophoresis analysis, Preparation of standards, Calibration of standards, Stability studies, o Calibration of equipments and LAL test o Bacterial Identification by biochemical and molecular methods. o TOC Analyzer (shimadzu), cleaning validation according to US-FDA. o AKTA pilot: which ensure the good laboratory practice GLP and current good manufacturing practice cGMP demands for Phase IIII in drug development and finalscale AKTA Purifier: Purification of protein microgram, milligram or gram scale. o Electrophoresis- Agarose and Acrylamide based, Western and Southern blotting. o Bacterial gene cloning by transformation, electroporation and conjugation, restriction enzymes and its use in molecular biology. Basics of Polymerase Chain Reaction (PCR) and its modifications based on use. o Bioinformatics, Biostatistics and Mathematical Simulations.
- 7. Academic Qualifications: Ph. D Molecular Microbiology (Through UGC Meritorious Fellowship) Maharaja Sayajirao University, Vadodara2009 M.Sc-Biotechnology-Through JNU national level entrance qualification.2004..Maharaja Sayajirao University, Vadodara B.Sc.- Chemistry, Zoology, Botany, Microbiology- 2002. Banaras Hindu University,Varanasi 10+2 Science, CBSE, Central Hindu School, BHU, Varanasi Advanced professional PG Diploma in Biopharmaceutical Regulatory Affairs.2012 Performance at Virchow Biotech Pvt Ltd Performance at Microtherapeutics Research Pvt Ltd,Chennai
- 8. Performance at Biozeen, Bangalore