*** ****** ***** ****: 817-***-****

Keller, Texas 76248 vlkdfm@r.postjobfree.com Cell: 682-***-****

EXECUTIVE SUMMARY: Accomplished manager with 15 years of experience in research and development in the areas of Pharmaceutical Product Development, Business Development, Operations and Project Management. Pro-active, innovative leader with successful record of accomplishment. A results-oriented team player who can effectively contribute to the growth of an organization through leadership, strong management, staff development, and communication. Demonstrated success in identifying and developing new market and business opportunities.

PROFESSIONAL EXPERIENCE

Virbac Corporation, Fort Worth, Texas 2005 –Present

Industry leader in the scientific research, development, and manufacture of quality proven pharmaceutical products.

Manager

Research and Development

Actively participate and lead the development of pharmaceutical drugs that in the past have increased sales by over 200 percent. Successfully designed and executed the first multi-center clinical efficacy trial conducted by the company. Manage the complete product development lifecycle and coordinate efforts with the Technical and International Development Groups, reducing development time by six to twelve months.

Management and Leadership

* Manage internal team of ten people including contract monitors that support development

* Manage and coordinate international projects including contract manufacturing abroad

* Estimate and manage both financial and resource requirements to support development objectives

* Proven ability to work with a cross-functional team in the creation of technology products and solutions that interface with emerging market needs and novel technologies

Marketing and Business Development

* Perform market and financial analysis of using extensive business background in the pharmaceutical industry for potential opportunities and assist with licensing and acquisition efforts

* Determined strategic direction for new product development that resulted in achieving corporate revenue and profitability objectives

* Provide technical advice on developing new business opportunities through acquisitions and strategic partnerships/alliances

* Significant experience working directly with customers, partners, and sales force to develop products meeting the unique requirements of the niche markets

* Successfully established a contract manufacturing facility in India and the U.S. and provided the regulatory support for registration of the sites

Product Development

* Coordinate studies for development of pharmaceuticals including non-clinical (laboratory) safety and clinical efficacy studies

* Review and approve GLP and GCP compliance and support standards for Quality Control of data

* Responsible for design of protocols for all new products

* Coordinate the overall monitoring of studies to ensure compliance with FDA and guidelines of relevant regulatory agencies

* Monitor studies to ensure conformance to Standard Operating Procedures (SOPs) during the trial progress

* Manage data through audit and statistical analysis

* Coordinate and manage the various technical sections of a new drug application including efficacy, safety, and CMC for submission to the FDA; proven track record of FDA approval with one-pass review of efficacy and safety trial protocols and submissions

Internal Communication and Progress

* Develop comprehensive testing and validation process and submit detailed analysis to FDA for approval

* Write and coordinate completion of final study report

* Provide clinical input to Project Team and technical advice to Marketing and Sales organizations

Health Canada, Ottawa, Ontario 2001 – 2005

Canadian federal regulator responsible for national public health.

Toxicologist Team Leader

* Responsible for leading risk assessments and industry interactions, literature reviews, and critical evaluations of submissions and data summaries

* Evaluated studies for accuracy and prepared verbal and written summaries of study reports for internal discussions and regulatory approval

* Evaluated and prepared critical scientific reviews on health risks (human and target animals) of chemicals used in food animal production

* Evaluated Final Study Reports of human vaccine trials for accuracy and prepared verbal and written summaries of study reports for internal discussions and regulatory approval

Comparative Toxicology Labs, Manhattan, Kansas 1999 – 2001

Instructor of Toxicology

* Participated in the clinical services program of diagnostic testing, patient care, and information responses in toxicology assistance to professional and public requests

University of Saskatchewan, Toxicology Center, Saskatoon, Saskatchewan, Canada

Graduate Teaching Fellow in Toxicology 1996 – 1999

E.R.C.M.P.U Ltd., (Milma.) Cochin, Kerala, India 1991 – 1993

* Evaluated the field efficacy and safety of vaccines and pharmaceuticals

EDUCATION & TRAINING

M.B.A., Health Care with specialization in Pharmaceutical Management, University of Colorado, Denver, Colorado, 2010

M.S., Toxicology, University of Saskatchewan, Saskatoon, Saskatchewan, 1999

Post Graduate Diploma, Regulatory Toxicology, University of Saskatchewan, Saskatoon, Saskatchewan, 1997

Residency in Pathology, Western College of Medicine, 1995

DVM. Kerala, India, 1991

B.S., Kerala University, India, 1984

Eligible to take the American Board Toxicology (ABT) Certifying Examination in 2012

OFFICES

President, Graduate Student Association, University of Saskatchewan, Canada, 1997 - 1999

AWARDS AND HONORARIA

Winner of the Research Seminar Poster Competition conducted by Kansas State University, 2000

University of Saskatchewan Graduate Scholarship in Toxicology, 1998 - 1999

Winner of the Toxicology Graduate Student Poster Competition conducted by the Toxicology Centre, 1998

Graduate Teaching Fellowship in Toxicology, 1997 - 1998 and Research Assistance, 1996 - 1997

PUBLICATIONS & RESEARCH PAPERS

Oehme, F.W., and S. Mannala, 2005, Paraquat, “Small Animal Toxicology,” Second edition (Peterson, M., and Talcott, P.A, Eds). Saunders, Philadelphia, 1964 – 1967.

J. A. Pickrell, F.W. Oehme and S. Mannala, 2003, Mycotoxins, “Clinical Veterinary Toxicology” (Plumlee, K, editor) Elsevier, Philadelphia, 270 – 271.

J. A. Pickrell, F.W. Oehme and S. Mannala, 2003, Tropane Alkaloids, “Clinical Veterinary Toxicology” (Plumlee, K, editor) Elsevier, Philadelphia, 381-384.

J. A. Pickrell, F.W. Oehme and S. Mannala, 2003, Carboxyatractyloside, “Clinical Veterinary Toxicology” (Plumlee, K, editor) Elsevier, Philadelphia, 385-387.

J. A. Pickrell, F.W. Oehme and S. Mannala, 2003, Avocado, “Clinical Veterinary Toxicology” (Plumlee, K, editor) Elsevier, Philadelphia, 424-427.

Wajdi M. Zoghaib, Shajan Mannala, V. Sagar Gupta, Guy Tourigny, R.Stephen Reid, “Synthesis, Conformation, and Antiviral Activity of 5-Methoxymethyl-2-deoxycytidine Analogs,” “Nucleosides, Nucleotides & Nucleic Acids, 2003, 22, 223 – 228.

F. W. Oehme, S. Mannala, 2001, Pesticides use in Veterinary Medicine, “Handbook of Pesticide Toxicology,” Second Edition, Vol. One, R. Krieger, Editor, Academic Press, San Diego, CA, 263 – 274.

A.L. Stuart, V.P.S. Kumar, S. V. Gupta, W. M. Zoghaib, C. K. Brown, S. Mannala, and T.J.L. Delbaere, “Relationship between Conformation and Antiviral Activity-IV,” “5-Ethyl-2'-Deoxyuridine and 5-Ethyl-2'-Deoxycytidine,” “Nucleosides Nucleotides” 1998, 17, 2219 – 2222.

ABSTRACTS

S. Mannala, S. Asmar, and J.A. Pickrell, “Health Effects of Inhaling Atmospheres of Swine Confinement Buildings: Earliest Detection of Immunologic Changes,” Central States Agricultural Health and Safety Conference, Kansas City, KS, (needs a city?) 2000.

PRESENTATIONS

“Premarket Regulatory Evaluation of Generic Antimicrobial Veterinary Drugs in Canada,” Annual Stake Holders Meeting, Ottawa, 2004.

Evaluation of Veterinary Drugs in Human Safety Division. “Presentation to the Environmental Assessment Unit,” Health Canada, Ottawa, April 2005.

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