Narayan C. Chaudhuri, PhD

Acton MA *****

ac3umr@r.postjobfree.com 978-***-**** linkedin.com/in/narayancchaudhuri

SENIOR PROCESS CHEMIST DIRECTOR OF PHARMACEUTICAL QUALITY CMC MANUFACTURING

Execute Diverse Projects in CMC Drug Development Clinical Manufacture Analytical Method Validation Genotoxic Risk Analysis Impurity Characterization Reference Standard Qualification Product Lifecycle Management

Senior process chemist and director of pharmaceutical product development, CMC quality and cGMP manufacturing of novel small and large molecule therapeutic drugs including peptides, oligonucleotides, protein biologics and antibody drug conjugates (ADC). Adept at API and DP batch manufacture, scale-up operation, technology transfer, PAR studies and analytical method and process validation. Skilled in quality control (QC), quality assurance (QA), deviation management, investigations, root cause analysis, corrective actions and preventative actions (CAPA) and CMC change controls.

Areas of expertise include:

- cGMP Clinical Batch Manufacture - CRO, CDMO and CMO Oversight - Vendor Qualification

- Six Sigma GB and RAC - FDA and ICH Drug Regulations - USP, EP and JP Procedures - Matrix Project Management - SPC, FMEA and QRM - TrackWise QMS System

PROFESSIONAL EXPERIENCE

ALEXION PHARMACEUTICALS INC., New Haven CT 7/2015-11/2017

Senior Manager of CMC Process Chemistry - External PD and cGMP Manufacturing

Overseen Alexion’s small molecule API and DP manufacturing campaigns under cGMP, delivering CTM for late-stage clinical trial of molybdenum cofactor deficiency (MoCD), a debilitating ultra-rare neurological disorder of newborns. Accomplished diverse matrix projects, working closely with functional managers and 15-20 technical staffs at multiple CROs CDMOs CMOs.

Executed cGMP batch manufacture, analytical method and process validation, PAR studies, quality risk assessment, ICH stability evaluation, genotoxic risk analysis and radiochemical synthesis, facilitating process characterization, product quality lifecycle management, animal tox studies and uninterrupted supply of clinical trial materials (CTMs).

Developed DP formulation, product specifications, release test acceptance criteria and method transfer protocols, and overseen late-stage CMC development along with technical transfers of process and analytical chemistries.

Resolved numerous deviations, investigations, CAPA and CMC change controls using TrackWise QMS system and authored CMC sections of IND, IMPD and NDA filings, enabling multiple dossier submissions and regulatory updates.

Authored and executed technical review of development reports, reference standard qualification, process comparability reports, impurity characterization, MBRs, QTAs, QAGs and batch production records, facilitating batch disposition and product release.

PHARMACEUTICAL QUALITY CMC GMP CONTRACT ASSIGNMENTS 1/2011-6/2015

Senior CMC QA cGMP Consultant, ARIAD PHARMACEUTICALS INC., Cambridge MA (2015-2015)

Coordinated as QA technical lead with CMC process chemistry, analytical method transfer, process validation and cGMP product manufacture, supporting Ariad’s late-stage small molecule anticancer drug development programs.

Led quality technical review and rapid approval of validation protocols, reports, batch production records, QC release testing data, deviations, investigations, CAPAs and CMC change controls, ensuring QA and regulatory compliance on all projects.

Compiled and verified batch disposition packages of bulk APIs and finished products, enabling on-time product release and supply of CTMs.

Senior CMC Process Chemist Project Manager, TAKEDA PHARMACEUTICALS INT’L CO., Cambridge MA (2012-2015)

Executed cGMP batch manufacture of Takeda’s anticancer drugs Velcade, Mepact and Adcetris (an ADC) at 4 major CMOs, advancing late-stage clinical evaluation, commercial launch and product quality lifecycle management.

Supervised cGMP campaigns at external CMOs and acted as person-in-plant (PIP), providing technical support and on-time resolutions to manufacturing events and clinical batch manufacture.

Resolved and driven over 150 CMC change controls, deviations, investigations and CAPAs to completion using TrackWise QMS system and collaborated with CCRB and MRB, implementing process changes and product quality risk assessment.

Authored CTD modules for CMC regulatory filings of NDA, BLA, MAA and ROW and collaborated as subject matter expert (SME) during regulatory inspections and GMP site audits.

Written, verified and approved nearly 300 MBRs, BPRs, specifications, validation study protocols, reports, APRs, PQRs and post-approval changes, ensuring QA and regulatory compliance.

Assessed numerous batch production records, IPCs, NORs, CPPs, KPPs, CQAs and QC release testing data, affording cGMP batch disposition, statistical data analysis and process trending.

Narayan C. Chaudhuri, PhD ac3umr@r.postjobfree.com Page Two

PHARMACEUTICAL QUALITY CMC GMP CONTRACT ASSIGNMENTS (Continued)

Senior CMC QA cGMP Consultant, AVEO ONCOLOGY INC., Cambridge MA (2012-2012)

Assessed cGMP gaps, process risks and product impacts and implemented corrective actions to Aveo’s late-stage drug substance and drug product manufacturing processes.

Authored and verified over 150 late-stage CMC study documents, validation protocols, reports, monographs, specifications, MBRs, BPRs and CTD modules, enabling NDA submission of novel RCC drug Tivozanib in 2012.

Collaborated as SME in FDA mock audits, ensuring CMC regulatory and QA compliances for PAI preparedness.

Senior CMC QA cGMP Compliance Specialist, GENZYME - A SANOFI COMPANY, Allston MA (2011-2012)

Assessed product impacts and quality risks due to non-conformance within commercial cGMP and bulk QA operations of novel Cerezyme and Fabrazyme protein biologics manufacturing processes and implemented corrective actions.

Resolved and achieved CMC regulatory approval of nearly 250 manufacturing deviations and investigations using TrackWise QMS system and utilized principles of Six Sigma, SPC, QbD, FMEA and cGMP, assuring product SISPQ and patient safety.

Applied Ishikawa fishbone 7M method to root cause analysis, collaborating with QC, QA, process validation and CMC, and implemented CAPAs for continuous process improvement as part of the Consent Decree Remediation Plan.

Additionally, worked as part-time Synthetic Process Chemist at PolyOrg Inc., Leominster MA (2011-2012), performing route designs, scale-up reactions and custom synthesis of novel small molecule APIs and API intermediates.

Obtained certifications in Six Sigma Green Belt (3/2011) and MassMEDIC Regulatory Affairs (6/2011).

SIRTRIS PHARMACEUTICALS INC. - A GSK COMPANY, Cambridge MA 11/2008-12/2010

Associate Director - API Chemical Process Development, CMC and cGMP Manufacturing

Directed cGMP external manufacturing, QC, QA and CMC functions of 4 synthetic small molecule APIs for clinical development against cancer, psoriasis and diabetes. Overseen the work of 20-25 technical staffs at multiple CROs CDMOs CMOs, and managed 1-2 direct reports along with a large number of matrix projects.

Accomplished 8 major cGMP campaigns of 3 x Phase I-II APIs in 5-50 kilo batches at external CDMOs including chemical and analytical development, GTI risk assessment, isotope and radiolabeling, process optimization and scale-up, supporting animal tox studies, clinical trials and solid dosage forms development.

Re-engineered manufacturing processes of 2 new chemical entities and transferred technology to external CMOs, improving process yields by 20% and reducing cGMP production cost by 30%.

Generated over $500K in 2009 annual savings via cost controls, COGS analysis and contract negotiations, and received Sirtris Employee Award in recognition of cGMP program management and CMC authorship of regulatory filings.

EPIX PHARMACEUTICALS INC., Lexington MA 4/2007-10/2008

Senior Manager - API Chemical Process Development, CMC and cGMP Manufacturing

Overseen CDMOs in the US, UK, Canada, India and Japan, directing CMC regulatory, cGMP, QC and QA functions of 5 novel small molecule drugs for major depressive disorder, Alzheimer’s disease, obesity, PAH, COPD and IBS. Managed 1 direct report and accomplished a large number of matrix projects, working directly with 25-30 technical staffs at multiple CROs CDMOs CMOs.

Executed analytical method development, polymorph screening, and solid state and stable salts characterization along with solid dosage formulation, ICH stability testing, photo-stability, forced degradation, DP encapsulation, dissolution studies and API radiolabeling, supporting multiple clinical development programs.

Authored numerous RFPs, CDAs, MSAs, SOWs, MBRs, specifications, product release criteria, QAGs and CMC sections of IND and IMPD documents, facilitating FDA and EMA regulatory filings.

Assembled emergency plans enabling critical clinical manufacture and on-time delivery of CTM to clinical sites, salvaging a $300K clinical study and received Epix Star Award in recognition of efforts.

IDENIX PHARMACEUTICALS INC., Cambridge MA 4/2002-3/2007

Principal Scientist - API Chemical Process Development and Scale-Up

Developed efficient synthetic manufacturing processes for novel C-branched nucleoside and L-nucleoside based APIs for the treatment of HCV and HBV infections. Managed 3 direct reports and project teams of 4-6 chemists.

Generated annual savings of over $1M by reducing production cost of a versatile carbohydrate API intermediate by 75% via process re-engineering and successful transfer of technology to CMO for large-scale production.

Invented new manufacturing processes for several small molecule non-nucleoside reverse transcriptase inhibitors (NNRTIs) designed to treat HIV infection, facilitating CMC process development and IND submission of one AIDS drug in 2006.

Collaborated with cross-functional project teams on CMC technical writing and analytical method development of novel HBV drug Tyzeka, enabling NDA submission and FDA approval in 2006.

Narayan C. Chaudhuri, PhD ac3umr@r.postjobfree.com Page Three

PRIOR RELEVANT EXPERIENCE

PHARM-ECO - A JOHNSON MATTHEY COMPANY, Scientist Senior Scientist, API Chemical Development and cGMP

HYBRIDON INC., Process Development Scientist, Oligonucleotide Synthesis

EDUCATION

Post-Doctorate, Chemistry (Bio-Organic), University of Illinois at Chicago IL and University of Rochester NY

PhD, Chemistry (Synthetic Organic), Indian Institute of Technology Kanpur

MSc and BSc Hons, Chemistry Major, University of Calcutta India

PROFESSIONAL DEVELOPMENT

Practical Approaches to Quality by Design (QbD), Scientific Update UK, Boston MA

MassMEDIC Regulatory Affairs Certification, WPI, Worcester MA

Six Sigma Green Belt Certification, Value-Train, Alpharetta GA

SOFTWARE SKILLS

MS Office, Excel, MS Project, PowerPoint, Visio, SciFinder, ChemDraw, Plateau LMS and TrackWise QMS.

TECHNIQUES, METHODS AND DATA SKILLS

FTIR, UV, NMR, HPLC, FPLC, IC, GC, MS, ICPMS, KF, DSC, TGA, DVS, XRPD, Microbial, LAL

TFF, UF DF, Lyophilization, CGE, PAGE, icIEF, ELISA, SEC, HIC and DNA RNA synthesizers.

MEMBERSHIPS

American Chemical Society - Division of Organic Chemistry

American Society for Quality - Division of Chemical and Process Industries

RECOGNITIONS

Worldwide Publishing Registry of Executives 2014

Cambridge Who’s Who Registry of Executives 2011

Global Directory of Who’s Who of Professionals 2010

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