Urgent candidates for RESEARCH INVESTIGATOR

Job Description

Job title: Research Investigator (Study Director) Job location: Bangalore Job grade: 7-IAbout 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 spiritMandatory expectation for all roles as per Syngene safety guidelinesOverall 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 timeCore Purpose of the Role:Responsible for ensuring that Genetic toxicology (Bacterial reverse mutation test, In vitro Chromosomal aberration and micronucleus test; In vivo Chromosomal aberration and micronucleus test) studies are carried out to the required scientific and regulatory standard and review and approve the study data. 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. Familiar with conducting all work in compliance with applicable regulatory requirements governing the work in which they are involved, such as GLP. Validating new in vitro studies as per the OECD guidelines requirement and others if anyRole 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 and conducting any activities in the facility as per Standard Operating Procedures. 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 material 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 receiving and evaluating their respective individual reports for inclusion in the final study report.Syngene ValuesAll employees will consistently demonstrate alignment with our core values Excellence Integrity ProfessionalismSpecific requirements for this roleExperience2-5 years of experience as study director or study personnel.Skills and Capabilities:Technical/ Functional Skills: You should have good understanding and hands on Experience of Genetic toxicology. Preferably have knowledge of related disciplines of slide scoring, cell culture handling and microbial counting Genetic Toxicology. Ideally, you should be working in or have Experience within, contract research; but a successful candidate may also have Experience from within pharmaceutical companies or have an academic background related to a Genetic Toxicology discipline.Behavioral/ Managerial Skills: A proactive attitude towards internal and external customer satisfaction and the highest standards of scientific quality and regulatory compliance. To be an excellent communicator with demonstrable skills in written, spoken and presentation media. Have a meticulous attitude towards consistency of 100% quality in study plan, reports and related material. Be aware of study status at all times and anticipate problems that may affect timing, quality or integrity and take appropriate action to resolve such problems.Other Job Requirements: Basic familiarity with Microsoft Office Suite. Computer skills, commensurate with Essential Functions and including ability to learn a validated system. Ability to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended shifts and/or extra shifts, sometimes on short notice. Ability to work under specific time constraints.Education PhD,

Keyskills :
process developmentcgmpcomputer skillscontinuous improvement facilitationprocess safetymicrosoft officedata integrityaccountabilityapi