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,Vadodara…2.2 Years...Salary(CTC): 25 Lakh + SUV
Car
• GM R&D- Virchow Biotech, Hyderabad…1.8 Years……Salary (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, Bangalore…2.5 Years…Salary (CTC):11 Lakh+ Others
• Senior Group Leader at Biological R & D (APIs) Concord Biotech Ltd, Ahmedabad…
1.7 Years…Salary(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,
Vadodara……………………………………………………………3 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 I–III 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, Vadodara…2009
• 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
