Research Scientist

Designation: Research Scientist (7-I)

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:

• Routine testing of stability samples using chromatographic, dissolution, and wet analytical techniques under a GMP environment following all cGMP practices


• Performing instrument calibration, method validation, and method transfers


• Interpretation of stability data and results trending


• Investigation of OOS/OOT and other laboratory events

• Preparing the Standard Operating Procedure

• Preparing stability summary reports and review of final documents


• Compliance & implementation of quality systems


• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety


• Responsible for the activities assigned within the team


• Deliver analytical results within the established windows and as per applicable guidelines


• Escalation of issues / non-conformity with applicable procedures/policies


• Electronic lab notebook documentation


• Troubleshooting HPLC and dissolution apparatus


• Miscellaneous lab responsibilities

Educational Qualifications: M. Sc. Chemistry or M. Pharm

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, method validation, and routine analysis


• 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 must

Experience:

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.


• Ability to meet tight deadlines and prioritize workloads.

Equal Opportunity Employer :

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