Shetty - Toxicologist - Secunderabad, Andhra Pradesh, India

Nitin Shetty

Secunderabad, Andhra Pradesh, India



  • Full time
  • Part time
  • One time
  • Contract
  • Temp

Work History

Senior Associate Director

Key Deliverables

Led a team of 18 associates and overlooking day-day activities in the safety assessment and animal PK activities
• Managed strategies for in-house drug discovery program, recommended plans, initiated new therapeutic areas for the new spin-off the company and proposals for identification of lead candidates.
• Oversaw quality aspects of biotech products, ensured safety of bulk and formulation for nation & international market release.
• Involved in identifying and proposing a second therapeutic area to enhance research capability portfolio for the new division of company.
• Identified required equipment, interacted with biomedical instrument companies and proposed purchase of sophisticated instruments /equipment for clinic.
• Prepared plans for annual capital and revenue budget for preclinical safety assessment division, manpower requirements and animal house.
• Proposed new project for new product launch as per market trend to strengthen company's brand profile.
• Successfully identified and prepared authorized Standard Operating Procedures (SOPs).

Associate Director

Chief Scientist (General Manager)

Chief Scientist (Deputy General Manager)

Senior Scientist

Key Deliverables:
• Planned and procured sophisticated instruments for various functions of laboratory.
• Prepared & edited authorized standards of operating procedures (SOP) and implementation of proper quality system for functions of laboratory.
• Co-ordinated with national/international regulatory authorities to procure guidelines, procedures, norms and requirements for investigational new drug application & new drug application of new chemical entities (NCEs).
• Effectively managed preparation of protocols and execution of all short and long term toxicity studies on NCEs as a study director.
• Co-ordinated with group of scientists to standardize in-vitro techniques for toxicity screening and establishing a genetic toxicology laboratory at nddr as a leader.
• Conducted training on toxicology and GLP concepts for 3 post graduate summer trainee students.
• Planned & designed a complete animal-house & animal experimental unit for a new facility at Gurgaon and a beagle dog facility at Chatturpur, New Delhi for carrying out in-house toxicity & pharmacology studies on NCE's.
• Created & submitted complete conceptual plans for setting up a GLP "National Facility for Regulatory Toxicology and Animal House for rodents, Beagle dogs and other non-rodents".

Preceding Assignment:

Sr Scientist - Toxicology

Ranbaxy Laboratories Ltd

New Delhi

Career Path:

Research Scientist (Toxicologist)





and sister concern of United Phosphorus Ltd.)
Career Path:

Research Officer

Ruia Analytical Laboratory


Career Path:

Junior Research Scientist

(Toxicology unit)
Year to 1992 Research Scientist


Vice President - Sr Management Role in Preclinical

• Masters and Ph.D degrees in relevance to drug toxicology

• 18 yrs of egregious experience in Drug Discovery Research at a Sr. position, including 4.5 yrs in Ranbaxy Laboratories Limited as Sr. Research Scientist-Toxicologist in the New Drug Discovery Research Division, 11 yrs as Head - Preclinical Safety Assessment Division & Animal house at Wockhardt Research Centre. as Sr. Associate Director, leading a team of 14 scientists & 12 support staff. Responsibility includes designing, management, interpretation & generation of profiles for kinetics & safety of New Chemical Entities, Biotech, NDDS & Veterinary products. Thorough knowledge & experience in handling & management of GLP studies & regulatory requirements for filing data to various countries. Initiated my career with a CRO – Jai Research Foundation, Vapi as a Sr Research Officer in Toxicology Division for 2 years which helped upgrade my GLP management abilities & understanding various regulatory guidelines compliance.

• Presently working with Vimta Labs Ltd one the leading CRO in India as a Vice President – Preclinical Division and leading a group of 54 associates which includes Managers, Group Leaders, Sr. Scientists, Scientists, Research Associates and support staff.

• Was a member of India’s ‘first’ New Drug Discovery Research group initiated by Ranbaxy Laboratories Limited, New Delhi. Instrumental in setting up of a fully functional toxicology & toxicokinetic lab. including planning different lab areas, proposing budgets (capital & revenue) identifying, negotiating, purchase of lab equipments & proposing man-power for specific areas. Had planned a state-of-the-art Toxicology Facility & Animal house & is established as per the proposed plan at Gurgaon, Haryana. The facility complies with international standards of Good Laboratory Practices.

• Part of the Drug Discovery core-group at Wockhardt for assessment of over-all profile of NCE & propose further action on ‘go-no go decision’. As a member of the strategic group involved in identifying and proposing a second therapeutic area to enhance research capability portfolio for the new spin-off company. Have been actively involved in setting up of a fully functional toxicity division & animal house including Beagle dog facility housing around 125 purpose bred Beagle dogs for drug discovery & biotechnology research. Was instrumental in team building and training for preclinical drug safety assessment & kinetics. An AAALAC and GLP approvable animal house and pre-clinical safety and bio-efficacy assessment facility is under constructed as per the plan proposed by me. Have attended several scientific meetings each year in the US & worldwide to be abreast of the newer scientific happenings & establish links with scientific experts. As toxicologist, also involved in a consulting role for evolving Phase I clinical trial protocols.
• Have set-up various in vitro & in vivo models to determine class specific & target organ toxicity.
• Had executed, generated & profiled safety data for numerous New Chemical Entities (NCEs) of which 4 NCEs (1 at Ranbaxy & 3 at Wockhardt) have been cleared by DCGI for clinical trails. Have been actively associated with Wockhardt’s Biotech group for development & marketing of Biovac (Hepatitis B Vaccine), Erythropoietin injection, Insulin & GCSF.
• Was an active member involved in successfully filing India’s first US-FDA IND for 2 antibacterial NCEs and obtaining permission for phase-1 clinical trials in the USA.
• Part of various patents granted for NCEs and NDDS.
• Was honored with the ‘Significant Performance Award’ for the year 2000 & 2003.
• In the company’s Core Group for decision making from the preclinical & safety aspects for generic and biotechnological products for introducing products in national & international (US & Europe) markets. Part of the due-diligence team for assessment of pre-clinical profile for in-licensing of products or company take-over.

• At Vimta labs, currently, instrumental in putting in place business plans to facilitate company's objective to cater to drug discover and development services for national and international drug discovery and biotechnology companies.
• Has established a multi-disciplinary team in line with the company’s strategic plans and has put in place core competencies in the areas of pharmacology, DMPK, Safety pharmacology and toxicology for start to end drug discovery solutions.
• Has help set-up a sate-of-the art GLP-compliant facility and have identified and installed sophisticated instruments and equipments to support various drug discovery activities.
• As a Test Facility Management instrumental in providing adequate resources to facilitate conduct of GLP studied for submission of toxicology and pharmacokinetic data to national and international regulatory authorities.
• The animal rooms comply to class 10000 specification and are designed to house multi-strained rats, mice, (including genetically modified rodents), Guinea pigs and rabbits. A separate 72 kennel Beagle dog colony with dedicated procedure, quarantine and examination rooms has been established.
• To date have completed 5 IND enabling studies on various class of NCEs to various global pharma cos. for US FDA submission.

Qualifications & Certifications

St Anthony - Bombay

Biological Sciences

Bombay University

Biological Sciences

Bombay University


Bombay University

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