Narayan C. Chaudhuri, PhD, Organic Chemistry

Executive Director of Process Chemistry, Pharmaceutical CMC, and cGMP Manufacturing at Atea Pharmaceuticals, Inc
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(386) 825-5501
Languages
  • English Full professional proficiency
  • Bengali Full professional proficiency
  • Hindi Native or bilingual proficiency
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Rob Whalen

Narayan was my CMC/technical counterpart at Epix. During that time, Narayan provided thorough technical oversight of our CMOs. Additionally, Narayan partnered superbly with QA & compliance (both internally & w/our CMOs). I hope to work again with Narayan & recommend him without hesitation."

Adel Moussa

Narayan is an outstanding synthetic organic chemist that has excellent process chemistry and pharmaceutical development expertise. He is a hard working chemist that has an impressive level of passion, focus and attention to details. Narayan’s innovative approaches and strong literature knowledge contributed to successful conclusion for several challenging projects. He proved himself as a capable leader in managing and outsourcing non-GMP and GMP production of Active Pharmaceutical Ingredients. In addition to his excellent professionalism, Narayan has a pleasant personality, easy to work with and is always keen on helping others.

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Credentials

  • Lean Six Sigma Yellow Belt (ICYB)
    ASQ - World Headquarters
    Oct, 2016
    - Nov, 2024
  • MassMEDIC RAC
    Worcester Polytechnic Institute
    Jun, 2011
    - Nov, 2024
  • Six Sigma Green Belt
    Value-Train
    Mar, 2011
    - Nov, 2024

Experience

  • Atea Pharmaceuticals, Inc
    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Executive Director of Process Chemistry, Pharmaceutical CMC, and cGMP Manufacturing
      • 2020 - Present

      Lead CMC chemical process and product development of Atea’s novel, transformative antiviral therapies for HCV, dengue, RSV, SARS, MERS, and COVID-19. Oversee manufacturing development, technology transfers, analytical development, and cGMP manufacture of novel drug substance (DS) and drug product (DP) processes at external CDMOs and CMOs supporting Atea’s clinical development programs. Review, verify, recommend, and approve technical data packages of drug stability time points, process transfer protocols, CMC change controls, batch production records, specifications, and batch release documents. Assess risks, deviations, investigations, and root cause analysis, implement CAPAs, and verify effectiveness checks. Author, review, and verify CTD Quality Modules of IND, IMPD, CTA, NDA, and MAA submission dossiers for regulatory filings to FDA, EMA, MHRA, PMDA, ANVISA, and rest of the world.

  • DPS Group Global
    • Ireland
    • Architecture and Planning
    • 700 & Above Employee
    • Senior CMC Technical Writer
      • 2018 - 2020

      2) Ziopharm Oncology, Inc., Boston, MA, 2020-2020. Provided technical support to process and product development of novel gene therapy drugs for rGBM, solid tumors, and leukemia. Reviewed, verified, and approved technical data packages of DS and DP stability time points, process transfer protocols, CMC change controls, and batch production records. Assessed deviations, investigations, root cause analysis, and CAPA; carried out technical writing, editing, and formatting of CMC documents, SOPs, and integrated development plans supporting Ziopharm’s clinical development programs. 1) Immunogen, Inc., Waltham, MA, 2018-2019. Authored a large number of GxP technical reports on process and product development supporting Immunogen’s monoclonal antibody (mAb) and antibody drug conjugate (ADC) clinical programs toward development of targeted therapies for ovarian cancer, acute myeloid leukemia (AML), and BPD cell neoplasm (BPDCN). Conducted technical writing, editing, and formatting of multiple CMC regulatory documents enabling submission of several IND, IMPD, CTA, and BLA dossiers for Immunogen’s clinical development programs. Edited, reviewed, and revised numerous technical documents per Immunogen Style Guide, AMA Manual, StartingPoint Author Toolkit, and CATSWeb QMS ensuring Immunogen’s compliance with ICH, FDA, and QA document publishing. Performed technical review and data verification of cGMP, GLP, GCP records of batch production, QC release, SEC-MS, binding ELISA, ADCC, CE-SDS, charge heterogeneity, icIEF, tryptic peptide mapping, DSC, CGE, HIC, HPLC, NMR, IR, UV, and DAR enabling approval of nearly 85-90 quality documents per Immunogen’s CATSWeb QMS system. Collaborated across process and analytical chemistry, manufacturing science and technology, QAO, QAD, and CMC regulatory teams advancing Immunogen’s clinical programs on CX-2009, IMGC-936, IMGN-529, IMGN-632, IMGN-779, and IMGN-853.

  • Tarveda Therapeutics
    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Senior Consultant of Process Chemistry, Pharmaceutical CMC, and cGMP Manufacturing
      • 2018 - 2018

      Employed through BioBridges LLC., Wellesley, MA. Provided technical consulting services to CMC process chemistry, analytical development, and cGMP manufacturing of Tarveda’s small molecule API and DP processes, technology transfer, scale-up operation, and process improvement for clinical development of targeted therapies to solid tumors via miniature drug conjugates (MDC). Accomplished 1 PRD project and 1 fully documented multistep production campaign of a key API regulatory starting material at 2 external CDMOs enabling clinical manufacture of an antitumor drug product. Part-time CMC Consultant to Prelude Therapeutics, Inc., Wilmington, DE. Assessed small molecule API synthetic processes of anticancer drugs for scale-up development and process implementation at external CDMOs and CMOs.

  • Alexion Pharmaceuticals, Inc.
    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Senior Manager of Process Chemistry, Pharmaceutical CMC, and cGMP Manufacturing
      • 2015 - 2018

      Led API process development and cGMP operations supporting clinical studies, API and drug product manufacture, stability evaluations, analytical validations, and process validations at external CMOs. Conducted late-stage CMC development, supply of clinical products, batch dispositions, and technical transfers of process and analytical chemistries in compliance with cGMP regulations and industry standards. Authored development reports, reference standard qualifications, impurity characterizations, MBRs, QTAs, QAGs, process comparability reports, and CMC sections of IND and IMPD filings. Assessed and managed workflow of deviations, investigations, CAPAs, ECs, and CMC change controls using TrackWise QMS.

  • Multiple Assignments
    • Cambridge, Massachusetts, United States
    • Senior Consultant of Process Chemistry, Pharmaceutical CMC, and cGMP Manufacturing
      • 2011 - 2015

      4) Ariad Pharmaceuticals, Inc., Cambridge, MA, 2015-2015. Employed through BioBridges LLC., Wellesley, MA. Supported CMC process chemistry, analytical method transfer, process validation, and cGMP manufacture of API and DP for Ariad’s late-stage small molecule anticancer drug development programs. Reviewed and approved validation protocols, stability reports, batch production records, and QC release data to ensure cGMP compliance. 3) Takeda Pharmaceuticals Co., Cambridge, MA, 2012-2015. Employed through ALG Partners LLC., Natick, MA. Oversaw cGMP batch manufacture, scale-up operations, technology transfers, and validations of Takeda's proprietary drug substance and drug product processes of Velcade for multiple myeloma, Mepact for osteosarcoma, and Adcetris for Hodgkin lymphoma at external CDMOs. Assessed and approved nearly 150 change controls, investigations, deviations, and CAPAs using TrackWise QMS. Collaborated with Supply Chain, QC, QA, and Corporate Compliance on quality risk management, regulatory compliance, and PAI readiness. 2) Aveo Oncology, Inc., Cambridge, MA, 2012-2012. Employed through BioBridges LLC., Wellesley, MA. Performed cGMP gap analysis and technical evaluation of CMC documents, analytical methods, method validations, stability protocols, and stability reports enabling PAI readiness and NDA submission of RCC drug Tivozanib in 2012. 1) Genzyme - a Sanofi Co., Allston, MA, 2011-2012. Employed through Yoh Services LLC., Philadelphia, MA. SME to bulk QA and cGMP operations of novel Cerezyme and Fabrazyme protein biologics manufacturing processes supporting Consent Decree Remediation. Liaised with corporate compliance, Reg CMC, process validation, and Quantic regulators on deviation management, investigations, root cause analysis, and CAPA implementation using TrackWise QMS. Earned Certifications in Six Sigma GB and Mass MEDIC RAC. 1a) Part-time Process Chemist at PolyOrg, Inc., Leominster, MA (2011-2012).

  • GSK
    • United Kingdom
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Associate Director of Process Chemistry, Pharmaceutical CMC, and cGMP Manufacturing
      • 2008 - 2011

      Worked at Sirtris Pharmaceuticals, Inc. - a GSK Company, Cambridge, MA. Authored several IND, IMPD, and CTA submissions to FDA/EMA/MHRA. Led sourcing, supply logistics, and CMC work plans on 4 major programs supporting pre-clinical and Ph-I&II clinical trials for development of novel therapies against cancer, psoriasis, and metabolic diseases. Led and liaised with GSK Tech Ops to accomplish cGMP manufacture of 4 small molecule APIs in 5-50 kilo batches at multiple CDMO sites in US, France, and Switzerland. Investigated deviations and implemented CAPAs/SOPs for continuous process improvement. Oversaw and managed the work of 20-25 external chemists, $4MM CMC budget, account payments, and tracking/timelines of multiple projects. Produced nearly $500K in 2009 savings through cost controls, COGS analysis, contract negotiations, and continuous process improvement. Two-time recipient of Sirtris Employee Award in recognition of exemplary contributions to regulatory CMC and program management.

  • Epix Pharmaceuticals, Inc.
    • Lexington, Massachusetts, United States
    • Senior Manager of Process Chemistry, Pharmaceutical CMC, and cGMP Manufacturing
      • 2007 - 2008

      Authored and submitted several IND/IMPD applications/annual reports to FDA/EMA. Managed multiple CDMOs/CROs in the US, UK, Canada, India, and Japan. Oversaw and managed the work of 25-30 external chemists, project timelines/tracking, $8MM CMC budget, and account payments. Spearheaded technology transfers, process/analytical development, and cGMP plant manufacturing of 4 small molecule drugs in 5-25 kilo batches. Led CMC functions of 4 programs for clinical development of novel drugs for major depressive disorder, Alzheimer’s disease, obesity, PAH, COPD, and IBS. Assembled emergency plans enabling critical manufacture and on-time supply of CTM to clinical sites, thereby salvaging a $300K clinical study and receiving Epix Star Award in recognition of efforts.

  • Idenix Pharmaceuticals, Inc.
    • Cambridge, Massachusetts, United States
    • Principal Scientist of Process Chemistry, Pharmaceutical CMC, and Scale-up Development
      • 2002 - 2007

      Investigated cost-effective scalable syntheses of several leading HCV and HBV drugs, directed teams of 4-6 chemists, and managed regulatory CMC oversight. Additionally, developed manufacturing processes for several small molecule HIV reverse transcriptase inhibitors facilitating CMC development and IND submission of 1 HIV drug in 2006. Pioneered the synthesis development and scale-up operations of 1 HCV drug enabling its CMC document compilation and IND submission in 2002. Led initiatives to improve the manufacturing process of a versatile carbohydrate intermediate and transferred new technology to CDMO for large-scale plant production reducing costs by 75% and generating annual savings of $1MM+. Provided CMC and analytical tech support to the NDA submission of HBV drug Tyzeka resulting in its FDA marketing approval in 2006. Published research papers in the OPRD journal and was granted patents WO 2004/052899 A2 and WO 2005/003374 A2.

  • Additional Experience
    • United States
    • Career Notes
      • 1989 - 2002

      Additional experience includes the following: Senior Scientist of Process Chemistry, Scale-up Development, and cGMP Manufacturing, Johnson Matthey Pharma Services (formerly Pharm-Eco Laboratories, Inc.), Devens, MA, 1997-2002. Assistant Professor of Chemistry, Birla Institute of Technology and Science, Pilani, RJ, 2000-2001. Process Development Scientist of Oligonucleotides Synthesis and Purification, Hybridon Inc., Milford, MA, 1996-1997. Post-doctoral Associate, Synthetic Organic and Bio-organic Chemistry, University of Illinois, Chicago, IL, 1995-1996. Post-doctoral Associate, Synthetic Organic and Bio-organic Chemistry, University of Rochester, Rochester, NY, 1992-1995. Research and Development Scientist of Mineral Processing Applications, Tata Research Development and Design Center, Pune, MH, 1990-1992. Research and Development Scientist of Decorative Paints Manufacturing and Industrial Coatings, Shalimar Paints Ltd., Howrah, WB, 1989-1990.

Education

  • University of Illinois at Chicago
    Post-doctoral Research, Synthetic Organic and Bio-organic Chemistry
    1995 - 1996
  • University of Rochester
    Post-doctoral Research, Synthetic Organic and Bio-organic Chemistry
    1992 - 1995
  • Indian Institute of Technology, Kanpur
    PhD, Synthetic Organic Chemistry
  • University of Calcutta
    MSc, Concentration in Organic Chemistry
  • Ramakrishna Mission Residential College
    BSc, Honors in Chemistry

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