Study Director

Job description

Job title: Senior Associate Scientist

Job location: Bangalore

Job grade: 8-II

About syngene:  syngene (www.syngeneintl.com) 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.