Senior Research Associate

3 days ago

Bangalore Karnataka, India Syngene International Full time

JOB DESCRIPTION Designation Senior Research Associate 9-II Job Location Bangalore Department BBRC PD ARD - GMP About Syngene Incorporated in 1993 Syngene International Ltd is an innovation-focused global discovery development and manufacturing organization providing integrated scientific services to the pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical industries worldwide Syngene s clientele includes world leaders such as Bristol-Myers Squibb Baxter Amgen GSK Merck KGaA and Herbalife Its innovative culture is driven by the passion of its 4240- a strong team of scientists who work with clients from around the world to solve their scientific problems improve R D productivity speed up time to market and lower the cost of innovation Job Purpose 1-2 Lines Analytical Research and Development working on Analytical GMP testing AGT and Syngene BMS Laboratory SBL stability programs Key Responsibilities Testing of samples drug substance and drug product for release testing and stability using chromatographic dissolution and wet analytical techniques under a GMP environment following cGMP practices Analysis of API clinical campaign samples manufactured in Syngene pilot plant Qualification or requalification of API reference standards Performing instrument calibration and qualification Performing method validation and method transfers Troubleshooting HPLC dissolution apparatus and other analytical instruments in the lab Deliver analytical results within the established windows and as per applicable guidelines Compliance implementation of quality systems Follow environment health and safety EHS requirements at all times in the workplace ensuring individual and lab plant safety Electronic lab notebook documentation Miscellaneous lab responsibilities Educational Qualifications M Sc Chemistry or M Pharm for 9-II Technical Functional Skills The candidate should have a good educational and theoretical analytical chemistry background Good knowledge of analytical techniques The candidate should understand instrument calibration qualification method validation and analytical testing Good understanding of documentation as per GxP requirements electronic notebook The candidate should have good proficiency in MS office tools Experience in stability samples testing and good knowledge of ICH guidelines cGMP regulatory requirements Must have worked in a cGMP-regulated environment exposure to regulatory inspections like US FDA MHRA etc is preferred Experience 3-5 years with M Sc or 1-2 years with M Pharm for 9-II Behavioral Skills Strong commitment toward work and a high level of dedication enthusiasm and motivation Good speaking-listening-writing skills attention to detail proactive self-starter Ability to work successfully in a dynamic environment Should be able to work in a team and flexible for working in shifts 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

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