Highly experienced & proven CMC leader, involved in advancement of several molecules from Pre-clinical to Commercial Readiness & finally to regulatory submissions (IND, NDA and BLA filing).1) Served as main liaison with internal and external customers. Facilitated regular internal and external meetings or project progress and challenges;2) Leading continuous improvement and operational excellence initiative;3) Visionary leader enhancing programs, processes, resource planning/scheduling, capacity use for productivity & operational efficiencies4) Led the evaluation & selection of CDMO's 5) Ensured optimal capacity utilization across sites to maximize output and execution of project timelines6) Seamless tech transfer across global sites Skills - leadership, strategic planning, collaboration, budgeting & forecasting, managing CDMO, team building, CMC activities related to IND, NDA, BLA & ANDA regulatory filing, commercialization, project management
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Managing DirectorQuench Life Sciences Jun 2022 - PresentHyderabad, Telangana, IndiaQuench is a chemical development company based in Hyderabad, India, providing range of services like 1) Discovery multi FTE's Synthetic Chemistry 2) Early Stage development and material generation to support GLP TOX and IND filing3) Late Stage Development using QbD Principles - FMEA analysis, risk ranking, DoE reactions and statistical analysis, establishing PAR & NOR ranges for process parameters, identification of critical process parameters (CPP's) & Control strategy4)… Show more Quench is a chemical development company based in Hyderabad, India, providing range of services like 1) Discovery multi FTE's Synthetic Chemistry 2) Early Stage development and material generation to support GLP TOX and IND filing3) Late Stage Development using QbD Principles - FMEA analysis, risk ranking, DoE reactions and statistical analysis, establishing PAR & NOR ranges for process parameters, identification of critical process parameters (CPP's) & Control strategy4) Fate and Purge studies of Impurities5) Custom chemical synthesis as per customer requirement6) Low and High molecular PEGs modifications, PEGylation and PEG conjugation to biologically active molecules, custom PEG synthesis, early and late stage development using QbD principles Show less -
Director, Process & Analytical DevelopmentNektar Therapeutics Jan 2020 - May 2022Hyderabad Area, India1) Strategic Planning and Supervision of functions 2) Leading continuous improvement & operational excellence initiative3) Early and Late stage development using QbD principles (FMEA, DoE, PAR Ranges and F & E work)4) Process validation & Process Characterization of NCE5) Manage CMO activities for scale-up and cGMP production of API’s; seamless tech transfer across global sites 6) Regulatory documentation for filing (IND, NDA & BLA) -
Associate DirectorNektar Therapeutics Jan 2017 - Jan 2020Hyderabad Area, India
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Sr. Scientist - IiNektar Therapeutics Dec 2014 - Dec 2016Hyderabad Area, IndiaResponsible for multiple R & D and manufacturing project to support the product portfolio. Perform DoE, analyze data as per the QbD guidlines -
Sr. ScientistNektar Therapeutics Jul 2011 - Nov 2014Hyderabad, India -
Scientist Ii-Process ChemistryNektar Therapeutics Jun 2009 - Jul 2011 -
Sr. Research ScientistSai Advantium Pharma Ltd Oct 2007 - Jun 2009Led the process development effort of several NCE’s and biologically active compounds followed by scale-up to deliver the high-quality compounds requested by customers. Broad exposure to a variety of synthetic manipulations & analytical procedures. Managed a team of 6 - 8 Scientists along with performance evaluation, provided project management support and ensured project timelines were met -
Senior Research Scientist IAmri (Albany Molecular Research Inc.) Aug 2005 - Oct 2007Managed a group of Scientist and performed on multiple R & D projects. Involved in multi-step synthesis of various target molecule as requested by customer
Devendra Singh, Ph. D. Education Details
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New Methodologies For The Synthesis Of Biologically Active Compounds -
Organic Chemistry
Frequently Asked Questions about Devendra Singh, Ph. D.
What company does Devendra Singh, Ph. D. work for?
Devendra Singh, Ph. D. works for Quench Life Sciences
What is Devendra Singh, Ph. D.'s role at the current company?
Devendra Singh, Ph. D.'s current role is Founding Director.
What schools did Devendra Singh, Ph. D. attend?
Devendra Singh, Ph. D. attended University Institute Of Chemical Technology (Formerly Udct), University Of Mumbai.
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Dr. Devendra Singh (Ph.D.)
Technology Manager @ Adani Solar | Semiconductor Manufacturing, Renewable Energy, Process & Product Development | Ex-Unist (South Korea), Nus (Singapore), Kaust (Ksa), Iitb (India)Gujarat, India1gmail.com -
Dr. Devendra Pratap Singh, Ph.D.
Ceo || Trade With Dr Devendra || Full Time Trader & TrainerJabalpur1yahoo.com
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