Sales Quality Control
Resume:
CURRICULUM VITAE
PRAVEEN KUMAR REDDY MOOLE D.V.M, M.Sc, DABT
Flat No 108, P. K Apartment,
Kuvempunagar, BTM 2nd stage
Bangalore,
Karnataka 560076, India
Phone: +919*********
Email: *************@**********.***
EDUCATION
Diplomate of American Board of Toxicology November 2010
American Board of Toxicology
(M. Sc Biotechnology) 2006 - 2008
Department of Distance education
Kuvempu University, Shimoga, Karnataka
Performance: GPA 66 % (1st Year)
Bachelors of Veterinary sciences and Animal husbandry (D.V.M) November 2001
College of Veterinary sciences,
Acharya N.G. Ranga Agricultural University,
Tirupati, Andhra Pradesh
Performance: Average GPA 7. 3 (on a 0-10 scale)
EXPERIENCE
Biocon Limited, Bangalore April 2010
Associate Scientific Manager
Biocon Limited is a fully integrated biopharmaceutical company focused on biopharmaceuticals, custom research and clinical research. It is a leading biopharmaceutical company in India.
My job responsibilities includes
• Managing a Team of 3 members.
• Designing and supervising of toxicology studies conducted in various laboratory animals (Rodents, Rabbits, Dogs and nonhuman primates). Types of studies include MABEL (Minimal anticipated biologic effect level), acute, subacute, subchronic and chronic toxicity and cross reactivity studies).
• Auditing preclinical CROs for their technical competency. Inviting quotations, assessment and selection, execution of Confidentiality Disclosure Document (CDA) & Master Service Agreement (MSA) with CRO by coordinating with Business and legal teams of Biocon and execution of toxicity studies.
• Monitoring study activities (Critical Phases) include but not limited to Protocol generation, discussion with study directors, pathologists and study teams, collection, analysis and interpretation of data and report writing/drafting.
• Preclinical toxicology functional representative in various projects comprising anti-cancerous biologics like monoclonal antibodies, generic small molecules and vaccines. This involves coordination with project leaders, for selection of relevant animal model, calculation of test item requirements, toxicity study designs and regulatory implications and qualification of CROs based on the principles of GLP.
• Preparation of preclinical toxicology portion for regulatory submissions such as BLA and IND.
• Coordination with scientists of other functional areas like bioanalytical, analytical formulation and Quality control.
• Training junior scientists of Preclinical development team in various areas of toxicology like dose selection, study design, interpretation of data, histopathology and animal models of diseases.
Ranbaxy Research Laboratories, Gurgaon September 2006 to March 2010
Senior Research Scientist
A pharmaceutical company with a global footprint in 49 countries, world class manufacturing facilities in 11 and a diverse product portfolio
My job responsibilities includes
• Managing a Team of 5 members.
• Functioning as a Study Director for both GLP and Non-GLP rodent and Non-rodent studies.
• Involved in planning strategies and timelines for the conduct of IND directive non-clinical studies- as an active member of project teams.
• Management of kennel facility.
• Coordinating, planning and monitoring of studies outsourced to CRO’s.
• Regular screening of new chemical entities (NCE’s) for toxicity in animal models.
• Preparing and reviewing dossiers required for the regulatory submissions.
• Conducting non-clinical toxicity studies for impurity qualification.
• Conducting non-clinical toxicity studies and providing regulatory support for Biosimilars and Herbal drugs.
• Preparing, reviewing and giving training on Standard Operating Procedures (SOPs) for the facility and studies (GLP compliance).
• Imparting GLP related training to new joiners.
• Standardizing and validating immunotoxicity studies (Plaque forming assay, Flow cytometry etc.).
• Developing and standardizing models for investigative toxicology studies.
Achievements
• Developed and standardized idiosyncratic rat model for screening NCE’s.
• Developed and standardized neutropenic and non-neutropenic rodent models to study efficacy of biogenerics.
• Successful achievement of GLP certificate from Indian GLP monitoring authority.
• Received “Certificate of Appreciation - 2007” (Team award) for outstanding contribution in qualification of the impurities of a Generic molecule.
• Received “Certificate of Appreciation - 2007” (Team award) for outstanding contribution in complete metabolic traceability of a NCE in Wistar rats using mass balance.
Dr. Reddy’s Laboratories Limited, Hyderabad April 2003 to March 2006
Junior scientist
A pharmaceutical company with a vision to become discovery led global pharmaceutical company.
My job responsibilities included
• General health monitoring of all laboratory animals.
• Conduct of GLP and Non-GLP studies in both rodents and non-rodents (Beagle dogs).
• Regular screening of new chemical entities (NCE’s) for QT prolongation potential in Beagle Dogs using conventional 10 lead systems.
• Regular screening of new chemical entities (NCE’s) for toxicity in animal models.
• Regulatory support for the launch of generics and biogenerics into regulated markets.
• Preparation of SOP’s and documentation to bring Dog facility under GLP.
• Initiation and responsible for the introduction of telemetry in Dogs.
Achievements
• Instrumental in developed and standardized dog model for screening NCE’s for their QT prolongation potential using conventional 10 lead systems. (This work was selected as the second best scientific work among 75 others at Dr Reddy’s Young Scientists Forum).
• Involvement from scratch and implementation of facilities, SOP’s and procedures required for GLP (Enabled us to achieve GLP certification from both Netherlands and Indian GLP monitoring authorities).
• Our team was nominated for “Chairman’s Excellence Award team award” for achieving GLP from Netherlands Govt.
Pfizer India Limited, Rajahmundry December 2001 to January 2003
Veterinary service officer
The world’s largest research-based pharmaceutical company
My job responsibilities included
• Promoting, creating demand and driving growth for innovative products.
• Achieving revenue budget, maximize sales for the territory in line with company’s strategic goals.
• Visiting doctors, chemists, Institutions, wholesalers and other customers in the assigned territory.
• Identifying business potential in the assigned territory and manage resources to exploit the opportunities.
• Identifying new customers/markets within the territory for progression of the business.
• Implementing other field actions as required to achieve the territory sales budgets.
Achievements
• Organized many veterinary camps.
• First person to implement innovative ways of marketing (taxi tours, group detailing, etc.) in the entire territory.
PUBLICATIONS/PRESENTATIONS
• Mechanism underlying peripheral edema produced by Rosiglitazone, a potent PPAR gamma agonist. Arun Kumar Singh, Praveen Kumar Reddy, Akshay D., K. B. Sunil Kumar, C. Seshagiri Rao. Poster Presentation in STOX on 28 – 30 October 2004, Trivandrum, Kerala.
CONFERENCES AND WORKSHOPS ATTENDED
• 23rd annual conference of STOX and National symposium on Good Laboratory Practice (GLP) and regulatory issues and CE course on GLP from 28-30 October at Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram.
QUALITIES AND ACHIEVEMENTS
Team-manship: Part of a team success in the achievement of GLP compliances at both companies.
Innovative: Developed a novel acute canine model for assessing QT interval in-vivo.
COMPUTER QUALIFICATIONS
• Good proficiency in Windows XP, MS-Word, MS-Excel, Power point, Adobe Photoshop, Adobe acrobat, and Scientific softwares: JANDEL SCIENTIFIC (Sigmastat / Sigmaplot), GraphPad Prism.
PERSONAL INFORMATION
• Date of Birth : 17th April, 1977
• Gender : Male
• Marital Status : Married
• Nationality : Indian
• Language : Telugu, Hindi, English
DECLARATION
I hereby declare that the above information is true and correct to the best of my knowledge.
Date: Signature
Place (M Praveen Kumar Reddy)
Contact this candidate