Syngene International Ltd is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation.
Post : Lead - Developmental and Reproductive Toxicology
Job Description :
Core Purpose of the Role :
As a Study Director – Developmental and Reproductive Toxicology (DART):
• Responsible for ensuring that GLP toxicology studies; developmental and reproductive toxicity studies 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.
• Attending client meetings, reviewing business proposals for DART studies
• Working as a SME in DART domain, managing and training team members
Mandatory expectation for all roles as per Syngene safety guidelines
• 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
Role Accountabilities
• Preparation of study plan considering the client requirements as well as regulatory requirements.
• Preparing a study schedule and communicating with all the study personnel and ensuring the proper conduct of the study.
• Preparing reports after completion of each study. This involves evaluating the data output by applying scientific knowledge and skills.
• To maintain the highest regulatory standards (GLP and AAALAC recommendations) during any activity conducted in the facility by continuous monitoring and checkup of all the instruments/equipment used in a study as per Standard Operating Procedures (SOPs).
• Preparation and periodic revision of Standard Operating Procedures.
• Preparation and presentation of experiment conduct protocols to the Institutional Animal Ethics committee.
• Periodically verify data generated during study.
• Archival of the study plan, study report, raw data and related materials as per the study plan.
• Coordinate with Principal Investigators and/or study personnel in case of multi-site studies keeping informed of their findings during the study and receipt and evaluation of their respective individual reports for inclusion in the final study report.
Candidate Profile :
1. Good understanding and hands on Experience of toxicology. Preferably have knowledge of related disciplines, toxicokinetics, pathology and analytical chemistry.
2. Candidate working in or have relevant experience in contract research organization will be preferred.
Additional Information
Experience : 9-12 years
Qualification : MSc, M.V.Sc., M.Pharm, PhD
Location : Bangalore
Industry Type : Pharma / Healthcare/ Clinical research
End Date : 10th May, 2023
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