A Professional Research Scientist, 15 years of GLP experience

Dr. V. Gayathri, M.Sc., Ph.D,

Nest Residency,

Sriram Nagar Colony,

P.O. Trimulgherry,

Alwal, Secunderabad- 500 015,

India

Mobile No. 888-***-****

Email Id. *****@**********.***

Deputy Test Facility Manager, since 2018 and Head of the Department, Ecotoxicology since 2015 in a leading OECD GLP certified and AAALAC accredited Contract Research Organization (CRO), with a professional experience in the areas of Aquatic and Terrestrial Ecotoxicology, Entomology and Molecular Biology. Awarded Postdoctoral Fellowship by the University of Witwatersrand, Johannesburg, South Africa. Member Secretary of Institutional Biosafety Committee (IBSC) and Member of Employees Health and Safety Committee. Selected from Asia for a training program on “Genes & Genomes: Infection Biology in the Tropics” in Makerere university, Uganda organized by the Makerere university, Kampala and Karolinska Institute, Sweden.

PROFESSIONAL SUMMARY

Responsible for overall Test Facility activities to comply with the OECD Principles of GLP and to ensure the operations and achieve the business goals of the Test Facility within the corporate guidelines and regulatory framework

Proven ability to maintain labs and lead key teams to assess and evaluate toxicity of crop protection products (agrochemicals/pesticides), industrial chemicals on laboratory plant/animal models following national and international guidelines and protocols for Aquatic and Terrestrial Ecotoxicological testing in compliance with OECD principles of GLP to meet global standards for regulatory registration mandate

Perform Ecotoxicological studies on microbial pesticides following OPPTS guidelines to meet global registration

Perform studies to assess the toxicity of test substances on the Zebra fish embryos and fish early life stage toxicity test

Perform studies to assess the toxicity of pesticides against household pests which includes bio efficacy, surface persistency and repellency as per WHO protocols

Well-versed in rearing techniques of Algae, Lemna sp., Daphnids, fish, Honey bees, earthworms, insects like mosquitoes (Anopheles stephensi, An.gambiae, An.funestus, Culex quinquefasciatus, Aedes aegypti), Silkworms, Houseflies, Cockroaches, Spodoptera litura, Heliothis armigera, Plutella xylostella and birds

Experience in establishing, maintaining and propagating in vitro cultures of the malaria parasite, Plasmodium falciparum and selection of resistance to the insecticides in the adult and larval mosquitoes as per WHO protocols

Aptitude to identify key personnel and develop suitable teams and guide them for project execution

Member Secretary of Institutional Biosafety Committee (IBSC) and Member of Employees Health and Safety Committee – RCC Laboratories India Private Limited, Hyderabad

Good in documentation practices

Excellent written, verbal and people skills, detail oriented, achiever, team player

Proven problem identification and solving abilities

SKILLS

Ensuring OECD principles of GLP are maintained

in the test facility and the non-clinical and environmental safety studies

Effective Cross Functional Communication

Establish & Maintain Ecotoxicology and Entomology

labs in accordance with principles of GLP & AAALAC

standards

Mentoring and Training of Staff

Liaison with sponsors, vendors, national and

international GLP authorities for implementation

of GLP compliance

People and Project Management

EMPLOYMENT HISTORY

FROM

TO

EMPLOYER

POSITION

Nov-2018

Till Date

RCC Laboratories India Pvt. Ltd.

Deputy Test Facility Management

Oct-2015

Till Date

RCC Laboratories India Pvt. Ltd.

Head, Department of Ecotoxicology

Mar-2012

Sep-2015

RCC Laboratories India Pvt. Ltd.

Study Director, Ecotoxicology

Mar-2011

Feb-2012

RCC Laboratories India Pvt. Ltd.

Study Personnel, Ecotoxicology

Jul-2010

Dec-2010

Pestiscience Intelligentsia, Chennai

Molecular Biotechnologist (Vector Borne Diseases)

Apr-2007

Apr-2008

University of Witwatersrand, Johannesburg, South Africa

Post-doctoral Research Fellow

Nov-2005

Feb-2007

IIBAT, Chennai

Scientist – Biotechnology

RCC Laboratories India Private Limited, Hyderabad Nov-2018 to Present

Deputy Test Facility Manager

Responsible for overall Test Facility activities to comply with the OECD principles of GLP

Ensure that sufficient number of qualified personnel, appropriate facilities, equipment and materials are available for the timely and proper conduct of the study

Ensure that the experimentation of laboratory animals at the test facility are done ensuring proper conditions of animal husbandry, maintenace and ethics to match international standards and national rules and compliance in force from time to time

Responisble for appointment of SDs, QA, Archivist, TIL, consultants, experts, advisors and other staff

Ensure that technically valid SOPs are established and followed and approve

To facilitate regular training of staff engaged in studies and to update GLP principles using internal and external faculty

Ensure the maintenance of master schedule of all GLP and non-GLP non-clinical safety studies undertaken by the test facility from time to time

Ensure periodical calibration of glassware, pipettes, syringes, balances, electronic items, computers and other items by nationally accredited agencies at periodical intervals

Ensure for a multi-site study that clear lines of communication exist between the SD, Principal Investigator(s), the QA and Study personnel

Assessing employees during annual appraisals

Liaise with national and international GLP authorities for implementation of compliance

Facilitate audit inspections of test facility and studies at the request of national and international authorities

RCC Laboratories India Private Limited, Hyderabad Oct-2015 to Present

Head, Department of Ecotoxicology

Maintenance of Ecotoxicology lab in compliance with OECD principles of GLP and AAALAC standards

Provide administrative and scientific support for ecotoxicology studies, including pre-study tasks (e.g. protocol development, scheduling), monitoring the in-life progress of assigned studies, and interacting with both domestic and global clients

Review and address quality assurance audits relating to protocols, amendments and reports (as applicable), with oversight. Follows up with appropriate personnel to ensure all necessary document/data clarifications are completed in the specified timelines

Ensure study compliance with the protocol, standard operating procedures, GLP, and other regulatory guidelines

Monitor the progress and status of assigned studies and ensure all client comments on protocols, amendments and reports are addressed in a timely manner

Serve as a contact, along with the Study Directors, in communication and interactions with other departments and clients

Provide administrative backup support for Study Directors and Study Personnel (12+) on day to day study-specific activities or tasks

Provide leadership, technical support, expertise for study design, analysis of data, and interpretation of results for all studies as necessary

Ensure study milestones are appropriately timed and meet necessary scientific and regulatory requirements

Handling difficult test substances and validating new study types to meet the regulatory demands

Assists with hosting client visits

Responsible for performance evaluation, hiring, and encourage/support of scientific and career growth of individuals within reporting line

RCC Laboratories India Private Limited, Hyderabad Mar-2011 to Sep-2015

Study Director– Ecotoxicology

Responsible for protocol preparation, design, study execution, data collection, and documentation of ecotoxicology studies in compliance with OECD principles of GLP

Represent single point of study control that requires direct communication with sponsors and an ability to work across functional units internally to plan, execute, and complete studies that meet sponsor requirements

Monitor all aspects of studies, analyze and interpret the results, and write a final report of the findings

Remain current on appropriate company SOPs, GLP regulations, and regulatory guidelines

Assure on-time delivery of high quality reports at the completion of each study, documentation in IUCLID

Calibration of lab instruments, culture and maintenance of algae, Lemna, daphnids, fishes, honey bees, earthworms and birds (Japanese quails, Pigeons, Domestic Chickens)

Pestiscience Intelligentsia, Chennai Jul-2010 to Dec-2010

Molecular Biotechnologist (Vector Borne Diseases)

Maintenance of household entomology laboratory and calibration of lab instruments

Culture and maintenance of household insects

Evaluation of pesticides against household pests, which includes bioefficacy, surface persistency and repellency studies as per WHO protocols

Analysis of data and interpretation of the results

National Institute for Communicable Diseases

University of Witwatersrand, Johannesburg Apr-2007 to Apr-2008

Post-doctoral Research Fellow

Rearing of insecticide resistant African malaria vectors

Establishing, maintaining and propagating in vitro cultures of the malaria parasite, Plasmodium falciparum.

Producing infective gametocytes of P. falciparum from the in vitro cultures

Artificially feeding and infecting vector mosquitoes with cultured gametocytes

Detecting evidence of infection in fed mosquitoes by immunological and molecular methods

Detection of circumsporozoite proteins of falciparum sporozoites

Extraction of RNA & DNA, gene amplification by PCR – Kdr gene in pyrethroid resistant mosquitoes, species-specific genes in malaria vectors, detection of P.falciparum

IIBAT, Chennai Nov-2005 to Feb-2007

Scientist –Biotechnology

Gene amplification by PCR – CaMV35S Promoter in GM products, Cry 1Ac gene in BT cotton

Qualitative and quantitative estimation of Cry 1Ac in GM crops using ELISA plate reader

Quantification of G6PD, monooxygenases, esterases, GST, AchE from the larval and adult mosquitoes using ELISA plate reader adopting WHO protocols.

Native and SDS PAGE

Effectively supported and played a main role of archivist successfully for German GLP audit

Rearing techniques of mosquitoes (Anopheles stephensi, Culex quinquefasciatus, Aedes aegypti), houseflies, cockroaches, Spodoptera litura, Heliothis armigera, Plutella xylostella

Selection of resistance to the insecticides in the adult and larval mosquitoes as per WHO protocols

Evaluation of pesticides against household pests, which includes bioefficacy, surface persistency and repellency studies

ACADEMIC CREDENTIALS

Post-Doctoral Research Fellow

University of Witwatersrand, Johannesburg, South Africa

2007-2008

Ph.D (Zoology -Toxicology)

University of Madras

2001-2006

M.Sc, Zoology

Madras Christian College

University of Madras

1999-2001

B.Sc, Zoology

Madras Christian College

University of Madras

1996-1999

RESEARCH EXPEENCE

Postdoc research: Long-term goal of the project was to produce infected mosquitoes to explore the host-parasite-pathogen interactions. Establishing, maintaining and propagating in vitro cultures of the malaria parasite, Plasmodium falciparum; Producing infective gametocytes of P. falciparum from the in vitro cultures and infecting vector mosquitoes with cultured gametocytes and to detect the evidence of infection in fed mosquitoes

Ph.D. Project title: Studies on certain biochemical parameters, knockdown resistance gene and antennal response in Anopheles stephensi Liston (Diptera: Culicidae) induced for deltamethrin resistance

M.Sc. Project title: Effect of Certain Natural products on the feeding and growth regulation in

Spodoptera litura (Fabricius) (Noctuidae: Lepidoptera)

TRAINING / WORKSHOPS/CONFERENCES ATTENDED

National Workshop on Regulatory Compliance for Accelerating Innovations

Attended”Training program on Importance of Quality animals in research and Occupational Health & Safety while working with Laboratory Animals” by Dr.Arvind Ingle, Scientific Officer, Tata Memorial Centre, Navi Mumbai

CDSCO, CDSA, BIRAC, Dept. of Biotechnology, Ministry of science and Technology, Govt. of India

RCC Laboratories India Private Limited, Genome Valley, Hyderabad

29, May 2019

09, September 2017

Attended”Training course for Study Directors of GLP Test Facilites” at IIHMR, Dwarka, New Delhi

Government of India, NGCMA, Dept. of Science & Technology

15-17, February 2016

Attended”In vitro and In vivo Mutagenicity Studies – Training by Dr. G.P.Meshram, Joint Director, Defence Research & Development Organization

RCC Laboratories India Private Limited, Genome Valley, Hyderabad

06 -10, November 2013

Attended”Training course for Study Directors of GLP Test Facilites” at National Academy of Agricultural Sciences (NAAS), National Agricultural Science Centre (NASC) Complex, New Delhi

Government of India, National GLP Compliance Monitoring Authority (NGCMA), Department of Science & Technology

17 -19, December 2012

Attended “ World Laboratory Animal Day and National Symposium on Laboratory Animal Science in the new millennium – Challenges and Solutions” held at NIN, Hyderabad

National Centre for Laboratory Animal Sciences, National Institute of Nutrition, Indian Council of Medical Research & Laboratory Animal Science Assosciation of India

24 – 25, April 2012

Training course on”Good Laboratory Practice” by Iris wuthrich, QCW Quality Consulting uthrich, GmbH, Switzerland

RCC Laboratories India Private Limited, Genome Valley, Hyderabad

16 July 2011

Attended a short course on “EPI INFO version 3.4.3” conducted by the Faculty of Health Sciences, School of Public Health

University of the Witwatersrand, Johannesburg

04 – 06, February 2008

Attended a three weeks course entitled, “Genes and Genomes in the tropics” conducted by the Makerere university, Kampala and Karolinska Institute, Sweden held at Makerere university, Kampala, Uganda

Makerere university, Kampala and Karolinska Institute, Sweden

04 -24, January 2006

Attended a workshop on “Issues of Good Laboratory Practice and Non-Clinical Safety Testing”

IIBAT, Chennai

14 -16, November 2005

Training in Electroantennogram (EAG) studies at SPIC Science Foundation, Tuticorin, Tamil Nadu

SPIC Science Foundation, Tuticorin, Tamil Nadu

April 2005

Training in biochemical and molecular biology techniques

Defence Research and Development organization (DRDO), Gwalior

April 2003

Participated in the workshop on “Good Laboratory Practices (GLP)” conducted by International Institute of Biotechnology and Toxicology (IIBAT) and Department of Science and Technology

IIBAT, Chennai

24 -26 October 2002

Observational training in the molecular biology techniques such as DNA extraction& Purification, Agarose gel electrophoresis of DNA and PCR

Vector Control Research Centre, Pondicherry

20-31, May 2002

Training course on ‘Aspects of GLP Compliance’

FIPPAT, Chennai

04 – 08, February 2002

V National Conference of AZRA

Madras Christian College, Chennai

27–29, December2000

8th National Symposium on Reproductive Biology and Comparative Endocrinology

Madras Christian College, Chennai

27- 29,

December 1999

PUBLICATIONS/PRESENTATIONS

Reduced susceptibility to deltamethrin and kdr mutation in Anopheles stephensi Liston, a malaria vector in India V.Gayathri and P.Balakrishna Murthy – Journal of American Mosquito Control Association 22(4):(2006).

Rotational application of bioinsecticide with deltamethrin – An antilarval measure for the control of filarial vector, Culex quinquefasciatus (Culicidae: Diptera) V.Gayathri, T. Jeyalakshmi, M.SunilDutt and P.Balakrishna Murthy. Journal of Environmental Biology, 25:(4)(2004).

Effect of certain plant derived compounds on the feeding and growth regulation in Spodoptera litura (Fabricius) Noctuidae : Lepidoptera V.Gayathri, R.W.Alexander Jesudasan and S.D.Wesley. Journal of Applied Zoological Researches, 14 (3):(2003).

Rotational application of insecticides in the control of mosquito, Culex quinquefasciatus (Culicidae: Diptera) V.Gayathri, T.Jeyalakshmi, R.Shanmugasundaram and P.Balakrishna Murthy. Published in the proceedings of National Symposium on Recent trends in Restoration of Aquatic Environment and Biodiversity of insects, 2003.

Insects as Informers V.Gayathri, T.Jeyalakshmi, M.SunilDutt and P.Balakrishna Murthy Pestology, 25 (12) (2001).

A Comparative study on the larvicidal property of various products against the larvae of Culexquinquefasciatus (Culicidae: Diptera)” R.Shanmugasundaram, M.SunilDutt, A.Arivazhagan, V.Gayathri, T.Jeyalakshmi and P.Balakrishna Murthy. Pestology, 25 (12) (2001).

Kdr mutation in deltamethrin resistant Anopheles stephensi. International Symposium on Insect Genetics and Genomics held at Centre for DNA Fingerprinting and Diagnostics, Hyderabad, India during 9-11 January 2006.

Rotating biopesticides with organophosphate- An antilarval measure for the control of malarial vector, Anopheles stephensi International Symposium and CME on modern trends in malaria held at All India Institute of Medical Sciences, New Delhi, India during 13th -15th February 2003.

Rotational application of insecticides in the controlof mosquito, Culexquinquefasciatus (Culicidae:Diptera) National Symposium on Recent trends in Restoration of Aquatic Environment and Biodiversity of insects held at Kongunadu Arts & Science College, Coimbatore, Tamil Nadu, India during 15th&16th February 2002.

ACHIEVEMENTS

Successfully faced 02 International GLP Audits and 10 National GLP audits from 2003–till date

Successfully validated aquatic ecotoxicology studies such as Fish embryo toxicity test, Fish- Early Life Stage Toxicity test, Daphnia Reproduction test, and terrestrial ecotoxicology studies such as earthworm reproduction test, Silkworm dietary toxicity test, Delayed neurotoxicity in chicken, Avian reproduction test,.

GLP Study reports generated have been widely accepted by regulatory agencies (EPA, ANVISA, etc..)

Selected from Asia for a training program on “Genes & Genomes: Infection Biology in the Tropics” in Makerere university, Uganda organized by the Makerere university, Kampala and Karolinska Institute, Sweden during the year 2006

Vasanthraj David Gold Medal for Zoology (Entomology) for the year 2000 - 2001

EXTRA-CURRICULAR ACTIVITIES

Served as a ZooClub Volunteer at Arignar Anna Zoological Park, Vandalur, Chennai from September 1998 – March 2000

Served the Zoological Society as an Editorial board member during the year 1998-1999.

PERSONAL PROFILE

Name : V.Gayathri

Date of Birth : 19.05.1979

Sex : Female

Marital status : Married

Nationality : Indian

Languages Known : Tamil, English, Telugu

Permanent Address : No.17A, Yamuna Street,

Balaji Nagar, Irumbuliyur,

East Tambaram,

Chennai- 600 059,

Tamil Nadu, India

REFERENCE

Dr. John Frean,

Associate Professor and Deputy Director,

Parasitology Reference Unit,

NICD/NHLS,

Sandringham 2131, South Africa

Email : *****@****.**.**

Phone : 002*-**-***-****

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