Job for M.Pharm, M.Sc as Study Director at Syngene International

Syngene Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities. The state-of-the-art research facilities have been qualified by various pharmaceutical majors & regulatory agencies and has received various certifications including ISO 9001: 2008, ISO 14001:2004, OHSAS 18001:2007, GLP and AAALAC.

Post : Study Director-Toxicology (2859)

Job Responsibilities:

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
Master degree in a life sciences discipline (MVSc / M.Pharm / M.Sc.) 4-5 years of industry (GLP) experience as study director or study personnel

Skills & Abilities:
• Good understanding and hands on Experience of toxicology. Preferably have knowledge of related disciplines, toxicokinetics, pathology and analytical chemistry.
• Candidate working in or have relevant experience in contract research organization will be preferred.

Other Job Requirements
Hands on experience with online data capture system [Provantis/Pristima]
Basic familiarity with Microsoft Office Suite.

Additional Information:
Education: MVSc /M. Pharm/ M.Sc
Industry Type: Pharma/Healthcare/Clinical research
Functional Area: R&D
Job code: 2859
LAST DATE: 5th May, 2018