Study Director

1 day ago

Bengaluru, Karnataka, India Syngene International Full time ₹ 9,00,000 - ₹ 12,00,000 per year
Job description
  • Overall adherence to safe practices and procedures of oneself and the teams aligned
  • Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company's integrity & quality standards
  • Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
  • Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
  • Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
  • Compliance to Syngene's quality standards at all times
  • Hold self and their teams accountable for the achievement of safety goals
  • Govern and Review safety metrics from time to time
Core Purpose of the Role:
  • Responsible for ensuring that GLP toxicology studies; acute, repeat dose and reproduction are carried out to the required scientific and regulatory standards as per Global regulatory guidelines [ICH/OECD].
  • Function as single point of study control, overall responsibility for the scientific, technical and regulatory conduct of studies, scientific interpretation, documentation and reporting of results.
Role Accountabilities:
  • Study Director for in vivo toxicology studies
  • Coordination with local cross-functional teams like veterinary science, biopharmaceutics, bioanalysis, pharmacokinetics or in vitro biology before, during and after execution of toxicology studies
  • Conduct of in-life phases of toxicology studies in rats, mice and rabbits
  • Dose administration in rats, mice and rabbits with various routes of administration
  • Use of on-line data capture system- Pristima
  • Blood sample collection for toxicokinetic
  • Assistance during necropsy activities such as organ weighing, data entry in PROVANTIS software
  • Assistance in conducting rabbit electrophysiology studies
  • Coordination with veterinary science team IAEC meetings- preparation and maintenance of FORM-B and FORM-D
  • Blood collection in rats and mice via different routes for clinical pathology analyses
  • Preparation and following of in-house SOPs
  • Co-ordination for preventive maintenance and calibration of instruments.
  • Archival of materials from toxicology studies.
  • Any other duties given from time to time by the line manager
  • Excellence
  • Integrity
  • Professionalism
Specific requirements for this roleExperience
  • 3-6 years
Skills and Capabilities:Education
  • MVSc
Equal Opportunity Employer:

Syngene International

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