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Anubhaw Kumar Singh
Bring Inspiration & Innovation, Combining techno commercial aspects to build Profitable Organization
Present Responsibilities at VTC are to oversee early and late stage Viral vaccine development to develop manufacturing
technologies compatible to cGMP, regulatory and technology transfer for commercial production. Coordination of Clinical Trial
Sample management & data analysis. Strategic & Operational Planning, Budgeting & best resource Utilization
____________________________________________________________________________________________________________________________
Birth & Personal : 12 Jan 1983, Indian, Married Male
Industries : Vaccine/biotech.
Experiences : 11 years of Experience
Current Role : Project/Product Manager & Leader for Viral vaccine development.
Reporting : Day to Day to General Manager, Monthly to CSO and CMD.
Personality : Hard worker, Dedicated, Accommodative, Collaborative, Multitasker, Creative
Performance Benchmark
• Key person in development, tech transfer, scale up & Process Validation batches of Live Measles, MMR,
Varicella, & MMRV vaccine from Cell banking, seed preparation to Upstream to lyophilized product, at
Clinical Trial Phase 1- 3& Under Market Authorization
• Vero cell (continuous) Culture under serum free condition in small scale bioreactor. CEF cell (primary) &
MRC-5 cell (finite) Culture in roller bottles.
• Contract project of MVDP & Syngene Planning, Scheduling, resource utilization to accomplishment in time.
• Faced several audit (CDL kasauli, DCGI, Local FDA & outsourcing organization) for test licence, Market
Authorization and achieved very minor compliance.
Talent
Technical
• Experienced in online cGMP doc., prepared Regulatory doc CMC, Summary Protocol for CRI.
• Able to trouble shoot and yield optimization for cell culture & virus amplification.
• Skilled in various platform like Roller Bottle, Cell stack, Bioreactor, Bello.
• Characterization and preparation of working cell bank, Virus seed Bank
• Skilled in Live & Killed Viral bulk production, recombinant vaccine with/without adjuvant and preservative
formulation, filling, Lyophilization & pack to fill finish.
Administration
• Owing the Project, Planning, organizing and prioritizing. Effective, Crisp & clear Communicator to all level.
• Project/Product Management & development of multiple projects simultaneously within timelines, PPT
presentation, WBS development, Resource Utilization, Budgeting, Costing etc.
•
Education
Exam Board/ University Specialization
MBA Post Graduate Certification in Business Management (ongoing)
IIT
Green belt SIX SIGMA Certified
MSc. Allahabad Agricultural university Biotechnology
BSc. Bangalore University Microbiology, Chemistry, Botany
HS
West Bengal Council of Higher
Secondary Education
Biology
1 | Page of Anubhaw Singh CV: EMAIL : ANUBHAW_SINGH@REDIFFMAIL.COM, M: +919712170520, PERMANENT : BORISHA CALCUTTA 8, WEST BENGAL
Anubhaw Kumar Singh
Bring Inspiration & Innovation, Combining techno commercial aspects to build Profitable Organization
Present Responsibilities at VTC are to oversee early and late stage Viral vaccine development to develop manufacturing
technologies compatible to cGMP, regulatory and technology transfer for commercial production. Coordination of Clinical Trial
Sample management & data analysis. Strategic & Operational Planning, Budgeting & best resource Utilization
____________________________________________________________________________________________________________________________
SSC West Bengal Board Literature, History, Geography, Science
Major Workshop/ Seminar/Summit attended
Sr. No Title Speaker Remarks
1.
Bio Pharma India Convention provide depth discussion on all aspects of
biopharmaceutical capabilities in India and globally
Visionary Leader panel-
Anand Kumar, Suresh
Jadav, Rakesh Dixit etc.
Organized by
Terrapinn
2
Evolving Trends in Regulation in the USA and the EU- challenges for
regulatory compliance, QbD, perspective as per ICH/EU/US
Bernd Renger, Manoj
Kumar, Ulrich reichert etc
Emprove Semimar
series
Carrier Trajectory
April 2011 to April 2013 with Zydus Cadila VTC as Deputy Manager (viral vaccine)
Project: Cell Culture Based viral vaccine development, optimization, clinical trial batch preparation to commercialization
Technical Duties Administrative Duties
• Vaccine bulk preparation, formulation, filling, lyophilization.
• Clinical Trial cGMP batch production.
• Technology transfer to commercial production unit.
• Scale Up and Process Validation batches
• Operation & strategic planning of various research project
• Trouble shooting & Risk assessment with CAPA and FMEA.
• In house & out sourced technology evaluation; feasibility study.
• High quality process documentation; preparation and update of
SOP, Protocol, CTD,-CMC, SLP, monthly progress report.
• Laboratory management, training of team, ensure cGMP. And
EHS, Resource & waste management,
• Project planning, forecasting, trouble shooting through
brainstorming with all level.
• Management of multiple projects simultaneously in timelines;
• Preparation of consumable & capex budget.
• Work & motivate the team towards team building.
• Effective communication with all levels of management.
• Negotiation with vendor for instruments & chemicals.
September 2009 to March 2011 with Zydus Cadila VTC as Senior Executive
Project: Sterile Concentrated bulk development, formulation, lyophilization and analytical method development
Technical Duties Administrative Duties
• Design & optimization of the MMR bulk development.
• Cell bank preparation & seed virus preparation.
• Media selection with commercially viable ingredients.
• Technology evaluation and feasibility study.
• Formulation, filling and lyophilization development.
• Laboratory management, cGMP and EHS compliance
• Indenting and negotiation with the vendor for different
instruments, chemicals and consumable.
• Lab maintenance, fixed time worker training.
• Preparation and update of Process SOP/ Protocol.
March 2008 to September 2009 with Panacea Biotec Limited as scientific officer
Project: Process Development for upstream, purification, lyophilization of various pilot scale trial project
Technical Duties Administrative Duties
• Process development for JE production in bioreactor.
• Feasibility studies under serum free condition.
• Scale Up studies from 2L-20 L.
• Formulation of live attenuated vaccine & lyophilization
• cGMP, cGLP documentation.
• Preparation and update of SOP/ Protocol.
• Preparation of purches order, indent of different chemicals.
March 2006 to March 2008 with Panacea Biotec Limited, Delhi India as Technical officer
Job Description: Assistance in vaccine development.
Technical Duties Administrative Duties
• Bioreactor and fermenter preparation for batch.
• Sample preparation and Analytical testing using SDS PAGE
western blot, Sterility, Potency Of viral vaccine.
• Environmental monitoring
• Running of Autoclave, DHS, continuous ultracentrifuge and
lyophilizer.
• Instrumentation control like cleaning, sterilization, calibration.
• Key responsible person for arranging fixed time worker during
shifts.
• Lab management- cleaning , fogging, and EMP
January 2005 to March 2006 with High Security Animal Disease Laboratory, Bhopal, on deputation by Panacea biotec ltd.
Project: Anthrax Vaccine testing on animals.
Technical Duties Administrative Duties
• Elisa Testing of rPA of anthrax and sample management. • Discussion and reporting to government scientist.
2 | Page of Anubhaw Singh CV: EMAIL : ANUBHAW_SINGH@REDIFFMAIL.COM, M: +919712170520, PERMANENT : BORISHA CALCUTTA 8, WEST BENGAL
Anubhaw Kumar Singh
Bring Inspiration & Innovation, Combining techno commercial aspects to build Profitable Organization
Present Responsibilities at VTC are to oversee early and late stage Viral vaccine development to develop manufacturing
technologies compatible to cGMP, regulatory and technology transfer for commercial production. Coordination of Clinical Trial
Sample management & data analysis. Strategic & Operational Planning, Budgeting & best resource Utilization
____________________________________________________________________________________________________________________________
• Bleeding and immunization of monkey .
• BSL4 lab management
• Indenting and negotiation with the vendor for different
chemicals and consumable.
• Observation of animals during quarantine and during testing.
Executive Value
Measles
Mumps
Rubella
Varicella
Flu
JE
Malaria
Hep B
Rabies
Exposure with Vaccine Life Cycle
Knowledge Area R&D
TT
Production
P. Management
Clinical Trial
Regulatory
Cell based live attenuated, inactivated viral vaccine technology
development and further production professional with over 11 years
of experience in industry. Strength lies in the field of bioprocess
execution and technical hand, development, production of viral
vaccine from seed development to fill finish. Also, has sound
knowledge and experience on technology transfer from R&D to
cGMP production, plant management, CTD preparation, and
Summary Protocol preparation, man power and project management.
Currently associated with Cadila healthcare Ltd. based at
Ahmedabad, India as Manager at Vaccine Technology Center
and maintains strong interdisciplinary cross functional activity
from discovery stage projects to cGMP clinical trial material
manufacturing to Commercial production. Working on various
viral vaccine (MMR, VZV, Influenza, rHPV, rMalaria, etc) using
cell culture platforms from concept to commercialization. This work
includes development of seed, cell substrate production, production
of bulk, clarification, formulation, filling single dose & multiple
dose presentation , lyophilization, Primary packing & in process
testing, Technology transfer, process validation, and setting of
cGMP facility to produce million doses of vaccine. Document
preparation (CTD, summary Protocol, Technology transfer
document, PV protocol, BMR, BPR, SOP) material management,
budgeting and plant designing with a group of fellow scientist.
3 | Page of Anubhaw Singh CV: EMAIL : ANUBHAW_SINGH@REDIFFMAIL.COM, M: +919712170520, PERMANENT : BORISHA CALCUTTA 8, WEST BENGAL
Anubhaw Kumar Singh
Bring Inspiration & Innovation, Combining techno commercial aspects to build Profitable Organization
Present Responsibilities at VTC are to oversee early and late stage Viral vaccine development to develop manufacturing
technologies compatible to cGMP, regulatory and technology transfer for commercial production. Coordination of Clinical Trial
Sample management & data analysis. Strategic & Operational Planning, Budgeting & best resource Utilization
____________________________________________________________________________________________________________________________
4 | Page of Anubhaw Singh CV: EMAIL : ANUBHAW_SINGH@REDIFFMAIL.COM, M: +919712170520, PERMANENT : BORISHA CALCUTTA 8, WEST BENGAL
Professional & Civic Affiliation
Mr.Sanjay Maheshwari
Past CRI, Kasauli, HP
Dr. Gaurav Gupta
HOD vaccine, VTC Zydus Cadila
Dr. Reinhard Gluch
CSO, VTC , Zydus Cadila
Dr. Gaurav Panday
MVDP,Bill & Milinda Gates Foundation
Dr. Arpan Maheshwari
General Manager, Incepta Pharma, Bangladesh
Dr.Anil Chawala
Scientist, WHO, Geneva
Social & Happening
www.Idreamlist.com
under construction
The web site created & dedicated
for the science to fullfill the need
of our global India, A platform to
find innovation and interact with
different scientist, to check their
contribution.
https://www.linkedin.com/pub/anubhaw-singh/26/40b/a6b

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Anubhaw MBA CV--2016

  • 1. Anubhaw Kumar Singh Bring Inspiration & Innovation, Combining techno commercial aspects to build Profitable Organization Present Responsibilities at VTC are to oversee early and late stage Viral vaccine development to develop manufacturing technologies compatible to cGMP, regulatory and technology transfer for commercial production. Coordination of Clinical Trial Sample management & data analysis. Strategic & Operational Planning, Budgeting & best resource Utilization ____________________________________________________________________________________________________________________________ Birth & Personal : 12 Jan 1983, Indian, Married Male Industries : Vaccine/biotech. Experiences : 11 years of Experience Current Role : Project/Product Manager & Leader for Viral vaccine development. Reporting : Day to Day to General Manager, Monthly to CSO and CMD. Personality : Hard worker, Dedicated, Accommodative, Collaborative, Multitasker, Creative Performance Benchmark • Key person in development, tech transfer, scale up & Process Validation batches of Live Measles, MMR, Varicella, & MMRV vaccine from Cell banking, seed preparation to Upstream to lyophilized product, at Clinical Trial Phase 1- 3& Under Market Authorization • Vero cell (continuous) Culture under serum free condition in small scale bioreactor. CEF cell (primary) & MRC-5 cell (finite) Culture in roller bottles. • Contract project of MVDP & Syngene Planning, Scheduling, resource utilization to accomplishment in time. • Faced several audit (CDL kasauli, DCGI, Local FDA & outsourcing organization) for test licence, Market Authorization and achieved very minor compliance. Talent Technical • Experienced in online cGMP doc., prepared Regulatory doc CMC, Summary Protocol for CRI. • Able to trouble shoot and yield optimization for cell culture & virus amplification. • Skilled in various platform like Roller Bottle, Cell stack, Bioreactor, Bello. • Characterization and preparation of working cell bank, Virus seed Bank • Skilled in Live & Killed Viral bulk production, recombinant vaccine with/without adjuvant and preservative formulation, filling, Lyophilization & pack to fill finish. Administration • Owing the Project, Planning, organizing and prioritizing. Effective, Crisp & clear Communicator to all level. • Project/Product Management & development of multiple projects simultaneously within timelines, PPT presentation, WBS development, Resource Utilization, Budgeting, Costing etc. • Education Exam Board/ University Specialization MBA Post Graduate Certification in Business Management (ongoing) IIT Green belt SIX SIGMA Certified MSc. Allahabad Agricultural university Biotechnology BSc. Bangalore University Microbiology, Chemistry, Botany HS West Bengal Council of Higher Secondary Education Biology 1 | Page of Anubhaw Singh CV: EMAIL : ANUBHAW_SINGH@REDIFFMAIL.COM, M: +919712170520, PERMANENT : BORISHA CALCUTTA 8, WEST BENGAL
  • 2. Anubhaw Kumar Singh Bring Inspiration & Innovation, Combining techno commercial aspects to build Profitable Organization Present Responsibilities at VTC are to oversee early and late stage Viral vaccine development to develop manufacturing technologies compatible to cGMP, regulatory and technology transfer for commercial production. Coordination of Clinical Trial Sample management & data analysis. Strategic & Operational Planning, Budgeting & best resource Utilization ____________________________________________________________________________________________________________________________ SSC West Bengal Board Literature, History, Geography, Science Major Workshop/ Seminar/Summit attended Sr. No Title Speaker Remarks 1. Bio Pharma India Convention provide depth discussion on all aspects of biopharmaceutical capabilities in India and globally Visionary Leader panel- Anand Kumar, Suresh Jadav, Rakesh Dixit etc. Organized by Terrapinn 2 Evolving Trends in Regulation in the USA and the EU- challenges for regulatory compliance, QbD, perspective as per ICH/EU/US Bernd Renger, Manoj Kumar, Ulrich reichert etc Emprove Semimar series Carrier Trajectory April 2011 to April 2013 with Zydus Cadila VTC as Deputy Manager (viral vaccine) Project: Cell Culture Based viral vaccine development, optimization, clinical trial batch preparation to commercialization Technical Duties Administrative Duties • Vaccine bulk preparation, formulation, filling, lyophilization. • Clinical Trial cGMP batch production. • Technology transfer to commercial production unit. • Scale Up and Process Validation batches • Operation & strategic planning of various research project • Trouble shooting & Risk assessment with CAPA and FMEA. • In house & out sourced technology evaluation; feasibility study. • High quality process documentation; preparation and update of SOP, Protocol, CTD,-CMC, SLP, monthly progress report. • Laboratory management, training of team, ensure cGMP. And EHS, Resource & waste management, • Project planning, forecasting, trouble shooting through brainstorming with all level. • Management of multiple projects simultaneously in timelines; • Preparation of consumable & capex budget. • Work & motivate the team towards team building. • Effective communication with all levels of management. • Negotiation with vendor for instruments & chemicals. September 2009 to March 2011 with Zydus Cadila VTC as Senior Executive Project: Sterile Concentrated bulk development, formulation, lyophilization and analytical method development Technical Duties Administrative Duties • Design & optimization of the MMR bulk development. • Cell bank preparation & seed virus preparation. • Media selection with commercially viable ingredients. • Technology evaluation and feasibility study. • Formulation, filling and lyophilization development. • Laboratory management, cGMP and EHS compliance • Indenting and negotiation with the vendor for different instruments, chemicals and consumable. • Lab maintenance, fixed time worker training. • Preparation and update of Process SOP/ Protocol. March 2008 to September 2009 with Panacea Biotec Limited as scientific officer Project: Process Development for upstream, purification, lyophilization of various pilot scale trial project Technical Duties Administrative Duties • Process development for JE production in bioreactor. • Feasibility studies under serum free condition. • Scale Up studies from 2L-20 L. • Formulation of live attenuated vaccine & lyophilization • cGMP, cGLP documentation. • Preparation and update of SOP/ Protocol. • Preparation of purches order, indent of different chemicals. March 2006 to March 2008 with Panacea Biotec Limited, Delhi India as Technical officer Job Description: Assistance in vaccine development. Technical Duties Administrative Duties • Bioreactor and fermenter preparation for batch. • Sample preparation and Analytical testing using SDS PAGE western blot, Sterility, Potency Of viral vaccine. • Environmental monitoring • Running of Autoclave, DHS, continuous ultracentrifuge and lyophilizer. • Instrumentation control like cleaning, sterilization, calibration. • Key responsible person for arranging fixed time worker during shifts. • Lab management- cleaning , fogging, and EMP January 2005 to March 2006 with High Security Animal Disease Laboratory, Bhopal, on deputation by Panacea biotec ltd. Project: Anthrax Vaccine testing on animals. Technical Duties Administrative Duties • Elisa Testing of rPA of anthrax and sample management. • Discussion and reporting to government scientist. 2 | Page of Anubhaw Singh CV: EMAIL : ANUBHAW_SINGH@REDIFFMAIL.COM, M: +919712170520, PERMANENT : BORISHA CALCUTTA 8, WEST BENGAL
  • 3. Anubhaw Kumar Singh Bring Inspiration & Innovation, Combining techno commercial aspects to build Profitable Organization Present Responsibilities at VTC are to oversee early and late stage Viral vaccine development to develop manufacturing technologies compatible to cGMP, regulatory and technology transfer for commercial production. Coordination of Clinical Trial Sample management & data analysis. Strategic & Operational Planning, Budgeting & best resource Utilization ____________________________________________________________________________________________________________________________ • Bleeding and immunization of monkey . • BSL4 lab management • Indenting and negotiation with the vendor for different chemicals and consumable. • Observation of animals during quarantine and during testing. Executive Value Measles Mumps Rubella Varicella Flu JE Malaria Hep B Rabies Exposure with Vaccine Life Cycle Knowledge Area R&D TT Production P. Management Clinical Trial Regulatory Cell based live attenuated, inactivated viral vaccine technology development and further production professional with over 11 years of experience in industry. Strength lies in the field of bioprocess execution and technical hand, development, production of viral vaccine from seed development to fill finish. Also, has sound knowledge and experience on technology transfer from R&D to cGMP production, plant management, CTD preparation, and Summary Protocol preparation, man power and project management. Currently associated with Cadila healthcare Ltd. based at Ahmedabad, India as Manager at Vaccine Technology Center and maintains strong interdisciplinary cross functional activity from discovery stage projects to cGMP clinical trial material manufacturing to Commercial production. Working on various viral vaccine (MMR, VZV, Influenza, rHPV, rMalaria, etc) using cell culture platforms from concept to commercialization. This work includes development of seed, cell substrate production, production of bulk, clarification, formulation, filling single dose & multiple dose presentation , lyophilization, Primary packing & in process testing, Technology transfer, process validation, and setting of cGMP facility to produce million doses of vaccine. Document preparation (CTD, summary Protocol, Technology transfer document, PV protocol, BMR, BPR, SOP) material management, budgeting and plant designing with a group of fellow scientist. 3 | Page of Anubhaw Singh CV: EMAIL : ANUBHAW_SINGH@REDIFFMAIL.COM, M: +919712170520, PERMANENT : BORISHA CALCUTTA 8, WEST BENGAL
  • 4. Anubhaw Kumar Singh Bring Inspiration & Innovation, Combining techno commercial aspects to build Profitable Organization Present Responsibilities at VTC are to oversee early and late stage Viral vaccine development to develop manufacturing technologies compatible to cGMP, regulatory and technology transfer for commercial production. Coordination of Clinical Trial Sample management & data analysis. Strategic & Operational Planning, Budgeting & best resource Utilization ____________________________________________________________________________________________________________________________ 4 | Page of Anubhaw Singh CV: EMAIL : ANUBHAW_SINGH@REDIFFMAIL.COM, M: +919712170520, PERMANENT : BORISHA CALCUTTA 8, WEST BENGAL Professional & Civic Affiliation Mr.Sanjay Maheshwari Past CRI, Kasauli, HP Dr. Gaurav Gupta HOD vaccine, VTC Zydus Cadila Dr. Reinhard Gluch CSO, VTC , Zydus Cadila Dr. Gaurav Panday MVDP,Bill & Milinda Gates Foundation Dr. Arpan Maheshwari General Manager, Incepta Pharma, Bangladesh Dr.Anil Chawala Scientist, WHO, Geneva Social & Happening www.Idreamlist.com under construction The web site created & dedicated for the science to fullfill the need of our global India, A platform to find innovation and interact with different scientist, to check their contribution. https://www.linkedin.com/pub/anubhaw-singh/26/40b/a6b