Narayan C Chaudhuri Ph D Organic Chemistry
About
Narayan C Chaudhuri Ph D Organic Chemistry is from Greater Boston. Narayan is currently Executive Director - CMC, Process Chemistry, and cGMP Manufacturing at Atea Pharmaceuticals, Inc, located in Boston, MA. In Narayan's previous role as a CMC Tech Ops Consultant and Data Reviewer at DPS Group Global, Narayan worked in Framingham, MA until Apr 2020. Prior to joining DPS Group Global, Narayan was a Technical Ops Consultant - CMC, Process Chemistry, and cGMP Manufacturing at Tarveda Therapeutics and held the position of Technical Ops Consultant - CMC, Process Chemistry, and cGMP Manufacturing at Watertown, MA. Prior to that, Narayan was a Senior Manager - CMC, Process Chemistry, and cGMP Manufacturing at Alexion Pharmaceuticals, Inc., based in New Haven, Connecticut, United States from Jul 2015 to Nov 2017. Narayan started working as Senior cGMP Chemist and QA Specialist - CMC, Process Chemistry, and cGMP Manufacturing at ARIAD Pharmaceuticals, Inc. in Cambridge, Massachusetts, United States in Mar 2015. From Nov 2012 to Mar 2015, Narayan was Senior Process Chemist at TAKEDA PHARMACEUTICALS AMERICA, INC., based in Cambridge, MA. Prior to that, Narayan was a Senior cGMP Chemist and QA Specialist - CMC, Process Chemistry, and cGMP Manufacturing at AVEO Oncology, based in Cambridge, MA from May 2012 to Nov 2012. Narayan started working as Senior cGMP Chemist and QA Specialist at Genzyme Europe B.V. in Allston, MA in Sep 2011.
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Narayan C Chaudhuri Ph D Organic Chemistry's current jobs
Executive Director: 2022-Present Senior Director: 2021-2022 Director: 2020-2021 Accomplishments: Technical lead of 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 batch execution of novel drug substance (DS) and drug product (DP) processes at external CDMOs supporting Atea’s clinical development programs. Reviewed, verified, recommended, and approved technical data packages of drug stability time points, process transfer protocols, CMC change controls, batch production records, specifications, and batch dispositions facilitating CMC development of new chemical entities (NCE). Assessed risks, deviations, investigations, and root cause analysis, implemented CAPAs, and verified effectiveness checks ensuring product quality documentation of clinical trial materials (CTM). Authored, reviewed, and verified CTD Quality Modules of IND, IMPD, CTA, NDA, and MAA submission dossiers facilitating regulatory filings to FDA, EMA, MHRA, PMDA, ANVISA, and rest of the world. Executed 8 major cGMP campaigns of AT-038, AT-527, and AT-752 DS delivering over 100 kg of clinical grade materials. Collaborated with Hoffmann-La Roche and Genentech on tech transfer and CMC authoring of a joint COVID-19 development program enabling a number of Ph 3 CTA and IMPD submissions during 2020-2021.
Narayan C Chaudhuri Ph D Organic Chemistry's past jobs
Accomplishments: 2020-2020 CMC Tech Ops Consultant Ziopharm Oncology, Inc., Boston, MA. 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 ensuring cGMP compliance and product quality documentation. Assessed deviations, investigations, root cause analysis, and CAPA; authored technical writing, editing, and formatting of CMC documents and SOPs, supporting Ziopharm’s clinical development programs. 2018-2019 CMC Technical Writer Immunogen, Inc., Waltham, MA. 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 for development of targeted therapies for ovarian cancer, acute myeloid leukemia (AML), and BPD cell neoplasm (BPDCN). Executed technical writing, editing, and formatting of a multitude of 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 publishing. Performed technical 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.
Contracted by BioBridges LLC., Wellesley, MA. Accomplishments: 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 MDC drug product. Part-time CMC Consultant to Prelude Therapeutics, Inc., Wilmington, DE. Assessed small molecule API synthetic processes of anticancer drugs accelerating scale-up development and process implementation at external CDMOs and CROs.
Accomplishments: Led API process development and cGMP operations supporting clinical studies, API and drug product manufacture, stability evaluations, analytical validations, and process validations at external CDMOs. 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 supporting corporate goals of product development. Authored development reports, reference standard qualifications, impurity characterizations, MBRs, QTAs, QAGs, and process comparability reports enabling CMC documentations for IND and IMPD filings. Assessed and managed workflows of deviations, investigations, CAPAs, ECs, and CMC change controls using TrackWise QMS ensuring quality documentation of CTM manufacture and product release for use in clinical trials. Earned Certification in Lean Six Sigma YB.
Contracted by BioBridges LLC., Wellesley, MA. Accomplishments: Supported CMC process chemistry and analytical method transfers for late-stage anticancer drug development. Reviewed and approved validation protocols, stability reports, and batch production records to ensure cGMP compliance. Collaborated with cross-functional teams to expedite the manufacturing of API and DP for Ariad Pharmaceuticals.
Contracted by ALG Partners LLC., Natick, MA. Accomplishments: 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.
Contracted by BioBridges LLC., Wellesley, MA. Accomplishments: Conducted comprehensive cGMP gap analysis and technical evaluations of CMC documents, such as analytical methods, method and process validations, batch production records, stability protocols, and stability reports to ensure compliance. Enabled PAI readiness and NDA submission for the RCC drug Tivozanib in 2012, collaborating with BioBridges LLC to enhance quality assurance processes at AVEO Oncology.
Contracted by Yoh Services LLC., Philadelphia, PA. Accomplishments: Acted as a Subject Matter Expert (SME) in bulk QA and cGMP operations of Cerezyme and Fabrazyme protein biologics. Collaborated with corporate compliance and regulatory bodies to manage deviations and implement CAPAs for continuous process and quality improvement as part of Genzyme’s Consent Decree Remediation Plan. Conducted investigations and root cause analysis using TrackWise QMS and Ishikawa fishbone 7M method, ensuring compliance with industry standards . Enhanced bulk quality assurance operations and cGMP compliance by applying principles of Six Sigma Green Belt and MassMEDIC RAC certifications. Part-time Process Chemist at PolyOrg, Inc., Leominster, MA. Synthesized small molecule APIs and process intermediates for scale-up development and client engagement.
Accomplishments: Authored several IND, IMPD, and CTA submissions to FDA, EMA, and MHRA. Led sourcing, supply logistics, and CMC work plans on 4 major programs supporting pre-clinical and Ph 1 & 2 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 and 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 by cost controls, COGS analysis, contract negotiations, and continuous process improvement. Two-time recipient of Sirtris Employee Award in recognition of exemplary contributions to CMC technical writing and program management.
Accomplishments: Authored and submitted several IND and IMPD applications and annual reports to FDA and EMA. Managed multiple CDMOs and 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 and 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.