Job Description

Designation: Senior Lead Scientist (6)

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
• Interpretation of data and results trending
• Investigation of OOS/OOT deviations and other laboratory events
• Preparing the Standard Operating Procedure
• Preparing validation report, method report and 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
• Handling electronic lab documentation and electronic quality management systems
• Miscellaneous lab responsibilities

Educational Qualifications: Ph.D

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 must

Experience: 0-2 years with Ph.D

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

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.