Project Manager Process
Resume:
MURUGAPPA VEDACHALAM, PhD
***********@*******.***
OBJECTIVE: A Leadership position in Pharmaceutical / Specialty products R&D/QA, process development
and Manufacturing.
SKILLS SUMMARY:
• PhD in Organic Chemistry and industrial experience in product development, Quality assurance and
regulatory, project management from process development and technology transfer to pilot plant and
to full commercialization of specialty products (generic and DEA controlled APIs, personal care), and
advanced pharmaceutical intermediates in CMO and CRO settings.
• Experience in setting up a cGMP Kilo-Lab [including writing policies and SOPs for equipment and
clean room qualifications and specifying reactor requirements] to manufacture clinical trial materials.
Good experience in helping purchase equipments and their installation (IQ) and commissioning (OQ).
• Excellent working knowledge in ICH Q7, Q8, Q9, and Q10) and FDA guidelines for cGMP
manufacturing of drug substances and drug products. Experience in Quality System
(cGMP, ISO9000), writing CMC part of regulatory filings and addressing FDA deficiency
findings. Experience in setting and monitoring Quality specifications, Change control,
qualifications, 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].
• Trained and experienced in Quality internal audit process.
• Experience in technology transfer and commercialization of bulk products ranging from 300gal to
5000gal volumes with 100Kg to 4,000Kg product batch sizes. Expertise in trouble-shooting,
proactively improving process throughputs and constantly maintaining processes.
• Thorough knowledge and understanding of vendor (external CRO and CMO) qualification
using the popular Q.U.E.S.T (Questioning, Understanding, Evaluation, Site audit and
Tracking) approach.
• Experience in establishing supply chain, overseeing QC, manufacturing personnel and resourceful to
QA during the transfer of processes to full commercialization.
• Extremely analytical and detail-oriented individual with an aptitude for organization, project planning,
and precision. High degree of ingenuity, creativity and resourcefulness.
• Hire and Supervise PhD, MS, and BS chemists. Willing to travel.
EXPERIENCE:
SAIC, Inc., Frederick, MD Feb. 2011 – Present
Title: Principal Life Scientist /Project Manager (contract)
Manage life sciences projects. Prepare for PMP certification.
PCI Synthesis / PolyCarbon Industries, Devens / Newburyport, MA. Nov. 2003 – May 2010.
3 A Contract Manufacturing Organization (18,000gal capacity; cGMP; FDA Inspected).
4 With continuous interaction with sales/marketing, costing, 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.
Periodically conduct Quality Internal Audit.
5 Supervise and mentor the R&D Group (PhD and BS chemists).
Title: Senior Group Leader (Hands-on), R & D Oct 2008 – May 2010
Sr. Principal Research Scientist, R & D Nov 2003 – Sept 2008
• Established a cGMP Kilo-Lab for low volume generic APIs and Clinical trial materials. Accomplished
several on time deliveries of Clinical and pre-clinical trial materials by a good and well coordinated project
management (2-3 annually) including phosphoramidates useful in anticancer treatments.
• Responsible for running GMP processes in co-ordination with both internal and customer QA, QC and
regulatory groups. Directed QC and analytical development groups to the needs of cGMP and non-cGMP
process transfers. Set Raw material and final product Quality specification controls, wrote batch records,
validation protocols and process deviation reports. Addressed CAPA generated during the audits and
cGMP campaigns.
• Developed and led an automated continuous process (in a Kilo-lab) for a generic API and formulated the
drug (for genital wart). Successfully managed a 3 month campaign (with an aggressive Project
Management) for the manufacture and validation of the commercial process (generating $700K revenue
in 2008-2009). Led the reverse engineering of Brand drug product and successfully formulated the
generic drug product. DMF filed (for API), ANDA approved in 2010 (for drug product).
• Developed new processes for 3 generic APIs (for Alzheimer, diabetes, hypertension) successfully
managed the projects from development to scale up and commercial manufacturing (estimated sales: $3-
5 millions). Coordinated with CMC parts of FDA filings.
• For generic APIs, established controls on potential process and degradant impurities observed during the
accelerated stability studies. Using ICH Q3A guidelines, classified impurities either as known or unknown
as well as specified or unspecified. Made impurity reference standards and qualified them. Coordinated
with CMC parts including identification of API molecule, impurities and Polymorphism reports in DMF
filings.
International Specialty Products (ISP), Assonet, MA. Nov. 1999 – May 2003
3 A Lead Manufacturer (37,000 gal capacity; cGMP, FDA Inspected) of Specialty products.
4 With continuous interaction with sales/marketing, costing, process development and project
management in commercialization of various specialty products..
5 Supervise and mentor 1MS and 1BS chemists.
Title: Research Scientist I, R&D
• Involved in process development and commercialization of DEA controlled Amphetamine salts
manufactured under cGMP. Amphetamine salts are APIs for treatment of ADHD (Attention Deficit
Hyperactivity Disorder).
• Developed and managed the project from process transfer to full commercialization of a novel process for
dihydroxydimethylpyridine used in hair care (~$500K annually).
• Troubleshot a process for making dodecyl tosylate, an intermediate that is used for making a personal
care product. The new process translated into a saving in revenue of an estimated ~$200,000 per year.
• Conceived and developed a new and novel process for making d-panthenyl triacetate, an ingredient
useful in personal care applications.
Borregaard Synthesis / PolyOrganix, Newburyport, MA. March 1996 – 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 – June 1998
2). Deputy Manager/Senior Process Development Chemist, June 1998 – Nov. 1999.
• Working with Pfizer, UK, led the advanced intermediate for Viagra drug substance 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, Borregaard’s Health, safety and Environmental division, manufacturing
personnel and Quality group in scaling up the product.
• Developed and led in scale up and commercialization of Dry-View Imaging product ($1.5-2.5Million).
EDUCATION
Ph.D. (Organic Chemistry, 1987), University of Madras, Madras, India
Postdoctoral Studies in the USA – 1988 to 1995.
SELECTED PUBLICATIONS
Patents
1. M. Vedachalam and J.K. Smith, Process for Producing 2,6-dihydroxy-3,4-dialkylpyridines, US
6,624,307 (2003).
2. M. Vedachalam and J.K. Smith, Process for Producing 2,6-dihydroxy-3,4-dialkylpyridines,
WO/200-***-**** (2003)
3. J.K. Smith, Zongzheng Liu, M. Vedachalam, and D.E. Compton, Process for making d-Panthenyl
triacetate, US 6,982,346 (2006).
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