MURUGAPPA VEDACHALAM, Ph.D.

264 Mohawk Road, Raynham, MA

(508) 884-4038 (Home)
Email: mv80363c@westpost.net
OBJECTIVE: A position in pharmaceutical Specialty products Regulatory/Quality or
R&D.
SUMMARY:
a PhD in Organic Chemistry and hands on experience in Chemical process developme
nt, project management from process development (including continuous process) a
nd scale up to pilot plant and to full commercialization of APIs (generic and DE
A controlled), specialty and advanced pharmaceutical intermediates (e.g. Viagra)
in CMO and CRO settings.
a Excellent knowledge in ICH Q7 and FDA guidelines for cGMP manufacturing of dru
g substances and drug products. Experience in Quality System (cGMP, ISO9000), wr
iting CMC part of regulatory filings and addressing FDA deficiency findings. Exp
erience in setting and monitoring Quality specifications, Change control, qualif
ications, deviations and CAPA and writing SOPs, batch records and a good working
knowledge with FMEA and various Root Cause Analyses [safety, product, process,
failure and system based approach].
a Experience in establishing supply chain, overseeing QC, manufacturing personne
l and resourceful to QA during the transfer of processes to full commercializati
on.
a Experience in providing Technical leadership for products from inquiry to full
commercialization. Managed full range of laboratory activities including resou
rce allocation, project management execution, costing and customer relations/ ma
nagement.
a Experience in commercialization of bulk products ranging from 300gal to 5000ga
l volumes with 100Kg to 4,000Kg product batch sizes. Expertise in trouble-shoot
ing, proactively improving and constantly maintaining processes.
a Extremely analytical and detail-oriented individual with an aptitude for organ
ization, project planning, and precision. High degree of ingenuity, creativity
and resourcefulness.
a Hire and Supervise PhD, MS, and BS chemists. Willing to travel.

EXPERIENCE:
PCI Synthesis / PolyCarbon Industries, Devens / Newburyport, MA. Nov. 2003 a" M
ay 2010.
1 A Contract Manufacturing Organization (18,000gal capacity; cGMP).
2 Focused on Process development and project management of the commercialization
of generic APIs, pharmaceutical intermediates and other fine chemicals. Custom
manufacture for clinical trial materials and pharmaceutical intermediates. Peri
odically conduct Quality Internal Audit.
3 Supervise and mentor the R&D Group (PhD and BS chemists).
Title: Senior Group Leader (hands on), R&D Oct 2008 a" May 2010
Sr. Principal Research Scientist, R & D Nov 2003 a" Sept 2008
a Led implementation of cGMP compliance in Devens Facility. Wrote and revised S
OPs to bring up the facility in compliance. Planned, conducted, and reported aud
it findings and metrics of cGMP activities.
a Responsible for cGMP processes in co-ordination with both internal and custome
r QA, QC and regulatory groups. Directed QC and analytical development groups t
o the needs of cGMP and non-cGMP process transfers. Set Raw material and final
product Quality specification controls, wrote batch records, validation protocol
s and process deviation reports. Addressed CAPA generated during the audits and
cGMP campaigns.
a Established and maintained a cGMP Kilo-Lab for low volume generic APIs and Cli
nical trial materials.
a Led the reverse engineering of Brand Drug product and successfully formulated
the generic drug product. Helped with DMF and ANDA filings.
a Developed new processes for 4 generic APIs (Alzheimer, Diabetes, and Hypertens
ion) successfully managed the projects from development to scale up and commerci
al manufacturing (estimated sales: $3-5 millions).
a For APIs, established controls on potential process and degradant impurities o
bserved during the accelerated stability studies. Using ICH Q3A guidelines, cla
ssified impurities either as known or unknown as well as specified or unspecifie
d. Made impurity reference standards and qualified them. Coordinated with CMC p
arts including identification of API molecule, impurities and Polymorphism repor
ts in DMF filings.
a Addressed FDA audit findings as well as DMF and ANDA deficiency letters.
a Accomplished several on time deliveries of Clinical and pre-clinical trial mat
erials by a good and well coordinated project management (2-3 annually).
International Specialty Products (ISP), Assonet, MA. Nov. 1999 a" May 2003
1 A Lead Manufacturer (37,000 gal capacity; cGMP, ISO9000) of high quality Speci
alty products.
2 Focused on Process development and project management in commercialization of
various specialty products including DEA controlled substances.
3 Supervise and mentor 1MS and 1BS chemists.
Title: Research Scientist I, R&D
a Developed an efficient process for Apomorphine, a high value therapeutic drug
for Parkinson disease and for Erectile Dysfunction (launched in Europe and filed
for approval in USA), from a CII controlled substance, Morphine sulfate. It ha
s a potential for $2-3Million per year. Involved in process development and com
mercialization of DEA controlled Amphetamine salts manufactured under cGMP. Amp
hetamine salts are APIs for treatment of ADHD (Attention Deficit Hyperactivity D
isorder).
a Developed and managed the project from process transfer to full commercializat
ion of a novel process for dihydroxydimethylpyridine used in hair care (~$500K a
nnually).
a Led successfully an overseas project management (~$100K annual budget) and tra
nsferred it to manufacturing.
a Troubleshot a process for making dodecyl tosylate, an intermediate that is use
d for making a personal care product. The new process translated into a saving
in revenue of an estimated ~$200,000 per year.
a Conceived and developed a new and novel process for making d-panthenyl triacet
ate, an ingredient useful in personal care applications. Set Raw material specif
ications for manufacture of new products and helped with other existing products
.
a Participated in Internal auditing of various functions of the ISO 9002 manufac
turing facility. Worked with the respective departments to implement various ma
jor and minor findings and observations.
a Directed QC and analytical development groups to the needs of cGMP and non-cGM
P process transfers.

Borregaard Synthesis / PolyOrganix, Newburyport, MA. March 1996 a" Nov 1999
1 A Contract Manufacturing Organization (16,000gal capacity; ISO9001).
2 Focused on Process development and project management in commercialization of
advanced pharmaceutical intermediates, and fine chemicals.
3 Supervise and mentor 1BS chemist.
Title: 1). Scientist II, R&D, March 1996 a" June 1998
2). Deputy Manager/Senior Process Development Chemist, June 1998 a" Nov
. 1999.
a Working with Pfizer, UK, led the advanced intermediate for Viagra drug substan
ce from its early development stages to scale up and its full commercialization.
Managed the project through commercialization (10MT over 4 month manufacturing
campaign; $1.6million revenue) by coordinating with local fire department, Borr
egaardas Health, safety and Environmental division, manufacturing personnel and
Quality group in scaling up the product.
a Successfully managed project from process development, optimization and commer
cialization of very cost effective processes for intermediates of Merckas Losart
an, an anti-hypertension drug,
a Developed and (or) managed several products for various pharmaceutical and agr
icultural products with cost cutting up to 80%.
a Developed and led in scale up and commercialization of Dry-View Imaging produc
t ($1.5-2.5Million).
EDUCATION
Postdoctoral:
Industrial/Academic
1). Stevens Institute of Technology, Hoboken, NJ, Senior Research Associate, Jan
1995 a" Feb 1996.
Had training in stereoselective synthesis of beta-lactam derivatives using micr
owave techniques; developed an analog (as a Contract Research for a startup Comp
any in CT) of (-) Cabenegrin A1, a potent antidote to poisonous South American s
nake (Bothrops atrox) venom and insect bites, E. coli endotoxins, botulism and o
ther neurotoxins and cardiovascular toxins at a large scale. The analog was mad
e in a simple 4 steps synthesis replacing the parent Cabenegrin A1 route involvi
ng about 12 steps.
2). University of Tennessee - Pharmaceutical Sciences, Memphis, TN, Senior Resea
rch Associate, Jan. 1994 - Dec. 1994.
Made potential Aldose reductase inhibitors (ARI) useful in treating complication
s (cataract) of diabetes mellitus. The enzyme has been linked to the accumulatio
n of polyols resulting in diabetes-associated structural and/or functional chang
es of peripheral nerves, lens, retina, cornea, iris, and kidney. ARIs appear to
provide a pharmacologically direct treatment for diabetic complications that is
independent of the control of blood sugar levels. Electron density modificatio
n around the C4 carbonyl in Sorbinil molecule was expected to undergo nucleophil
ic interaction with the enzyme leading to an increase in its activity.
3). University of New Orleans, New Orleans, LA, Jan. 1989 a" Dec. 1993.
Designed and made high energetic materials include both sensitive and insensitiv
e organic compounds with high density, high detonation velocity (Dv) and high de
tonation pressure (Dp).
Successfully made and tested both caged and quasi-caged polycyclic polynitramine
s.
Teaming with Researchers at US Naval Weapons Center, China Lake, developed a sca
lable process to make a highly strained and caged hexaazaisowurtzitane polynitra
amine (CL-20). It is powerful non-nuclear explosive with very high density (2.0
4), high detonation velocity and pressure. It is 14% powerful than HMX
Developed synthetic routes for making insensitive high energy tetraoxadinitramin
e analog of CL-20 with a density 1.99 and comparable detonation velocity. It is
less shock and friction sensitive than HMX or RDX and is thermally stable.
Both CL-20 and its Tetraoxadinitramine analog are scaled up to pilot scale.
Designed and synthesized Quasi-caged polycyclic nitramines that are comparable h
igh energy compounds (to CL-20) using highly corrosive acidic reagents like 100%
nitric acid or nitronium tetrafluoborate in combination with acids like polypho
sphoric acid, antimony pentafluoride.
4). Clemson University, Clemson, SC, Senior Research Associate, Nov. 1987 a" Dec
. 1988.
Made 1,2-oxaphospholene oxide derivatives, potential lead compounds for herbicid
al and cytokynin activity.

Ph.D. (Organic Chemistry), University of Madras, Madras, India a" 1987.

M.S. (Organic Chemistry), University of Madras, Madras, India.
B.S. (Chemistry), University of Madras, India.
Professional Training and Membership:
American Chemical Society: Member since 1988.
Pilot Plant Studies and Process Scaling for Batch and Semi batch Processing, Jul
y 28-30, 1997
GMP Training: 4 days, February, 2000
Process Improvement with Multivariable Testing (MVT(R)), April 4, 2001.
Business Software Trainings: SAP, Macola and JBA System21.
Root Cause Analysis training, July 2009

PUBLICATIONS
Patents
1. M. Vedachalam and J.K. Smith, Process for Producing 2,6-dihydroxy-3,4-dialkyl
pyridines, US 6,624,307 (2003).
2. M. Vedachalam and J.K. Smith, Process for Producing 2,6-dihydroxy-3,4-dialkyl
pyridines, WO/2003082821 (2003)
3. J.K. Smith, Zongzheng Liu, M. Vedachalam, and D.E. Compton, Process for makin
g d-Panthenyl triacetate, US 6,982,346 (2006).
In International Journals
1. Benzenesulfonyl-2-bromomethyl-3-phenylthioindole as a Synthon for 2-substitut
ed indoles: A new synthesis of 2-Aminomethylindoles, D. Nagarathnam, M. Vedachal
am, and P.C. Srinivasan, Synthesis, 1983, 156.
2. A facile preparation of 2-alkylindoles a" potential intermediates for alkaloi
ds, M. Vedachalam, B. Mohan, and P.C. Srinivasan, Tetrahedron Letters, 1983, 353
1.
3. Synthesis of 2-(2-arylethyl)indoles, B. Mohan, M. Vedachalam, D. Nagarathnam,
and P.C. Srinivasan, Synthesis, 1985, 188.
4. 4,10-Dinitro-2,6,8,12-tetraoxa-4,10-diazatetracyclo[5.5.0.05,9.03,11]dodecane
, V.T. Ramakrishnan, M. Vedachalam, and J.H. Boyer, Heterocycles, 1990, 31, 479.
5. 2-Azidoallylphosphonates: Synthesis and Applications to formation of 4-amino-
2-ethoxy-1,2-oxaphosphol-3-ene 2-oxides, R.A. Abramovitch, K. Konieczny, W. Penn
ington, S. Kanamathareddy and M. Vedachalam, J.Chem.Soc., Chem. Commun., 1990, 2
69.
6. Dense compounds of C,H,N, and O atoms. Nitramine derivative of diimino- and d
ioxo-decahydro-1H,5H-diimidazo[4,5-b:45-e]pyrazine, M. Vedachalam, V.T. Ramakris
hnan, and J.H. Boyer, Heteroatom Chem., 1991, 2, 313.
7. Facile synthesis, and nitration, of cis-syn-cis-2,6-dioxodecahydro-1H,5H-diim
idazo[4,5-b:45-e]pyrazine, M. Vedachalam, V.T. Ramakrishnan, J.H. Boyer, I.J. Da
gley, K.A. Nelson, H.G. Adolph, R. Gilardi, C. George, and J.L. Flippen-Anderson
, J. Org. Chem., 1991, 56, 3413.
8. Dense compounds of C,H,N, and O atoms II. Nitramine and nitrosamine derivativ
es of 2-oxo- and 2-iminooctahydroimidazo[4,5-d]imidazole, M. Vedachalam, V.T. Ra
makrishnan, and J.H. Boyer, Heteroatom Chem., 1991, 2, 669.
9. Synthesis of 2-Alkylindoles, B. Mohan, M. Vedachalam, and P.C. Srinivasan, In
dian J. Chem., 1992, 31B, 685.
10. 2,6-Dithiodecahydro-1H,5H-diimidazo[4,5-b:45-e]pyrazine and related dioxo- a
nd dimino-decahydroimidazopyrazines, M. Vedachalam and J.H. Boyer, Heteroatom Ch
em., 1993, 4, 85.
11. 2-Alkylindoles via Wittig olefination of indole-2-aldehyde, M. Vedachalam, E
.V. Sadanandam, and P.C. Srinivasan, Indian J. Chem., 1993, 32B, 481.

In Conference and Meetings

1. J.H. Boyer, M. Vedachalam, A.M. Krishnan, G. Kumar, V.T. Ramakrishnan, and L.
T. Wolford, aC- and N-nitro Chemistrya, Naval Weapons Center, China Lake, CA, De
cember, 1989.
2. R.A. Abramovitch, M. Vedachalam, S. Kanamathareddy, and W. Pennington, a2-Azi
doallylphosphonates: Synthesis and applications to formation of 4-amino-2-ethoxy
-1,2-oxaphosphol-3-ene 2-oxidesa, 199th ACS National Meeting and Exposition, Bos
ton, MA, April, 1990, Division of Organic Chemistry, Article 372.
3. M. Vedachalam, V.T. Ramakrishnan, J.H. Boyer, I.J. Dagley, K.A. Nelson, H.G.
Adolph, R. Gilardi, C. George, and J.L. Flippen-Anderson, aFacile synthesis, and
nitration, of cis-syn-cis-2,6-dioxodecahydro-1H,5H-diimidazo[4,5-b:45-e]pyrazin
ea, NSW Southern Highlands Conference on Heterocyclic Chemistry, Bowrel, NSW, Au
stralia, September, 1991, Article 177.
4. M. Vedachalam and H. Rathore, Processes on Benzylic brominations, Borregaard
R&D conference, Sarpsborg, Norway, September, 1997.
5. M. Vedachalam, K. Neuman, J. Farina and H. Rathore, 2-Chloroquinoline: Proces
s development and Scale up, Heterocyclic Chemistry, Gordon conference, Newport,
RI, July, 1999.