Study Director - Toxicology

Job description

Job title: Study Director - Toxicology

Department: Safety Assessment

Job location: Bangalore

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:

• You will be responsible for ensuring that acute, repeat dose, toxicokinetic and reproduction toxicology studies are carried out to the required scientific and regulatory standard and review and approve the study data.
• You will be the single point of study control and have overall responsibility for the scientific, technical and regulatory conduct of studies allocated to you as well as for the interpretation, documentation and reporting of results.
• You will be familiar with conducting all work in compliance with applicable regulatory requirements governing the work in which they are involved, such as GLP.

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.

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

• M.Sc

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.