Job Description

JOB DESCRIPTION
Designation: Research Associate (9-I) or 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:
xc2xb7 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
xc2xb7 Analysis of API clinical campaign samples manufactured in Syngene pilot plant
xc2xb7 Qualification or requalification of API reference standards.
xc2xb7 Performing instrument calibration and qualification
xc2xb7 Performing method validation, and method transfers
xc2xb7 Troubleshooting HPLC, dissolution apparatus and other analytical instruments in the lab
xc2xb7 Deliver analytical results within the established windows and as per applicable guidelines
xc2xb7 Compliance & implementation of quality systems
xc2xb7 Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
xc2xb7 Electronic lab notebook documentation
xc2xb7 Miscellaneous lab responsibilities
Educational Qualifications: M.Sc. Chemistry for 9-I; M.Sc. Chemistry or M. Pharm for 9-II;
Technical/Functional Skills:
xc2xb7 The candidate should have a good educational and theoretical, analytical chemistry background
xc2xb7 Good knowledge of analytical techniques
xc2xb7 The candidate should understand instrument calibration, qualification, method validation, and analytical testing
xc2xb7 Good understanding of documentation as per GxP requirements (electronic notebook)
xc2xb7 The candidate should have good proficiency in MS office tools
xc2xb7 Experience in stability samples testing and good knowledge of ICH guidelines & cGMP regulatory requirements
xc2xb7 Must have worked in a cGMP-regulated environment, exposure to regulatory inspections like US FDA, MHRA, etc. is preferred.
Experience: 1-2 years with M.Sc. for 9-I ; 3-5 years with M.Sc. or 1-2 years with M. Pharm for 9-II
Behavioral Skills:
xc2xb7 Strong commitment toward work and a high level of dedication, enthusiasm, and motivation
xc2xb7 Good speaking-listening-writing skills, attention to detail, proactive self-starter
xc2xb7 Ability to work successfully in a dynamic environment
xc2xb7 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.