NARAYAN C.

CHAUDHURI, PHD
40 Faulkner Hill Rd * Acton, MA 01720
* 978.394.6505 * nc10677a6@westpost.net * www.narayanchaudhuriphd.com * www.link
edin.com/in/NarayanCChaudhuri
QUALIFICATIONS PROFILE
CMC ~ Technology Transfer ~ cGMP Manufacture ~ Chemical Process Developmen
t ~ API
Chemical Development and GMP Operations Director with an award-winning track rec
ord of achievement in technology transfer, development of robust chemical proces
ses, strategic outsourcing, CMC management and CTM supply operations of investig
ational new drugs. Exceptional ability to manage complex projects while ensuring
on-time delivery of goods and services. Brings a tenacious work ethic and an ap
preciation for new challenges. Excellent negotiation and communication skills. E
xpertise includes:
* Synthetic Organic Chemistry
* cGMP Manufacture of API and Drug Products
* Solid State Characterization and Analytical Development
* CMC and Quality System Management * Scale-up of Chemical Processes
* Pre-Formulation Physical Chemistry
* Outsourcing and Vendor Relations
* Regulatory and ICH/FDA Compliances
PROFESSIONAL EXPERIENCE
SIRTRIS PHARMACEUTICALS, INC. - A GSK COMPANY, Cambridge, Massachusetts
2008 - 2010
Associate Director of API Sourcing and Manufacturing
Steered the process transfer and cGMP manufacture of 3 clinical development cand
idates. Drove multiple projects on new synthetic route development, preparation
and qualification of analytical reference standards, development of analytical t
est methods, and long-term stability studies of investigational new drugs. Appli
ed principles of chemical process design and in-process analytical testing to co
ntrol API process impurities and suspected genotoxins. Led sourcing, logistics,
and production scheduling in support of clinical trials. Authored IND, IMPD and
CTA applications. Established strong vendor relationships with multiple CMOs and
CROs.
* Honored with the Sirtris Employee Award 2009 & 2010 for exemplary contribution
s to the CMC regulatory team.
* Produced nearly $500,000 in 2009 savings through cost controls, contract negot
iations and continuous improvement of manufacturing processes.
* Conceived cost-effective routes for improved synthesis of 2 new chemical entit
ies, resulting in 20% increase in overall yields and 30% reduction in production
costs.
* Accomplished 8 major cGMP manufacturing campaigns of 3 Phase I-II candidates p
roducing abundant supplies of APIs to support animal tox studies, clinical trial
s and formulation development.
* Achieved 100%+ of all individual and cross-functional team goals.
EPIX PHARMACEUTICALS, INC., Lexington, Massachusetts 2007 - 200
8
Senior Manager of CMC
Spearheaded the technology transfer, process development and cGMP manufacture of
4 active drugs targeted at major depressive disorder, Alzheimer's disease, obes
ity, PAH, and COPD being studied in Phase I-II clinical trials. Directed the man
ufacture and distribution of up to 100,000 solid dosage forms of these drugs. De
livered strong technical support to project teams in the development and validat
ion of analytical test methods. Worked closely with Legal and Finance teams to m
anage confidentiality disclosures, service agreements, work orders, and CMC budg
et. Authored IND applications, and built strong vendor relationships with multip
le CMOs and CROs.
* Recognized with the Epix Star Award 2007 & 2008 for enabling critical drug sup
plies to clinical sites, and for synthesizing a number of new lead compounds for
biological testing.
* Played a critical role in improving and implementing superior manufacturing pr
ocesses for 4 active pharmaceutical ingredients and their synthetic intermediate
s.
* Managed multiple projects at 5 major contract sites including pre-formulation
development, solid state characterization, logistics, project meetings and site
visits.
* Assumed all responsibilities of the Senior Director of CMC upon his departure
shortly after being hired, and established a strong working relationship with th
e VP of Manufacturing.
NARAYAN C. CHAUDHURI, PHD PAGE TWO
PROFESSIONAL EXPERIENCE
IDENIX PHARMACEUTICALS, INC., Cambridge, Massachusetts
2002 - 2007
Principal Scientist of Chemical Development
Developed and demonstrated scalability of manufacturing routes to several HIV re
verse transcriptase inhibitors, facilitating an IND submission in 2006. Investig
ated cost-effective scalable syntheses for lead HBV drugs, and led the work of u
p to 6 chemists assigned to project-based teams.
* Drove joint efforts of 5 scientists overseeing the development and scale-up of
an efficient synthetic process for one HCV drug, resulting in its IND submissio
n in 2002.
* Explored synthetic routes to create a cost-effective scalable process for a ve
rsatile sugar derivative NOV3 and transferred the technology to an outsourcing p
artner, enabling large scale production at 60% less costs.
* Made significant contribution to late-stage development of an HBV drug, Tyzeka
which received FDA approval in 2006.
* Published 2 papers in the OPRD journal and was granted 2 patents WO 2004/05289
9 A2 and WO 2005/003374 A2.
PHARM-ECO - A JOHNSON MATTHEY COMPANY, Devens, Massachusetts
1997 - 2002
Senior Scientist of Chemical Development and cGMP Manufacturing (1998 - 2002)
Conducted thorough evaluations of tech-transfer packages, synthetic route develo
pment, process development, and cGMP manufacture of active pharmaceutical ingred
ients. Managed and developed project-based teams of up to 6 chemists, including
performance evaluations. Built strong business relationships with clients.
* Directed a team of 6 scientists through the successful completion of 3 major c
ampaigns of a client project, implementing cGMP manufacture of 4 target compound
s on multi-kilo scales.
* Crafted high-yielding manufacturing processes for a hetero-aromatic migraine d
rug intermediate and a novel cyto-differentiating agent, resulting in the cGMP p
roduction on multi-kilo scales.
* Successfully designed and implemented superior manufacturing processes for 4 a
nti-sense API building blocks.
Scientist of Chemical Synthesis and Scale-up (1997 - 1998)
* Formulated a scalable synthetic route to a novel nucleoside analog used in the
treatment of many types of lymphoid neoplasms, leading to its cGMP manufacture
on kilo scales.
* Invented and implemented an efficient purification process to isolate a comple
x anti-tumor indole alkaloid with greater than 98% purity.
* Led a team of 4 chemists through the initial research, development and scale-u
p synthesis of 4 API building blocks.
Additional Experience
HYBRIDON, INC., Milford, MA - Process Development Scientist
TATA RESEARCH DEVELOPMENT & DESIGN CENTER, Pune, India - Research Scientist
SHALIMAR PAINTS LTD., Calcutta, India - Research Scientist
EDUCATION
Post Doctoral, Synthetic Organic Chemistry * University of Illinois, Chicago, Il
linois
Post Doctoral, Synthetic Organic and Bio-Organic Chemistry * University of Roche
ster, Rochester, New York
PhD, Synthetic Organic Chemistry, 10.00 / 10.00 GPA * Indian Institute of Techno
logy, Kanpur, India
MSc, Concentration in Organic Chemistry, 98.4th Percentile * University of Calcu
tta, Calcutta, India
BSc, Chemistry Major, 99.9th Percentile * University of Calcutta, Narendrapur Ra
makrishna Mission, India
PROFESSIONAL AFFILIATIONS
* American Chemical Society * The Global Directory of Who's Who * Cambridge Wh
o's Who