MSc/MPharma Vacancy as Associate Scientist at Syngene

Syngene hiring for Safety Assessment as Study Director for GLP in-vivo toxicology studies

Qualification: MSc/M.Pharma
Experience : 3 to 6 years
Location: Bangalore

Job description

Job title: Associate Scientist

Job location: Bangalore

Job grade: 8-I

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:

• 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 yearsSkills 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.

How to Apply

Interested candidates can mail their CVs to minakhi.bhowmick@syngeneintl.com

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