Study Director

Job description Job title Senior Associate Scientist Job location Bangalore Job grade 8-II About syngene syngene is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At syngene safety is at the heart of everything we do personally and professionally Syngene has placed safety at par with business performance with shared responsibility and accountability including following safety guidelines procedures and sops in letter and spirit 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 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 As a Study Director - Toxicology 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 Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience 3-6 years Skills and Capabilities 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 Education MVSc Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity EEO to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local law In addition Syngene will provide reasonable accommodations for qualified individuals with disabilities