Senior Lead Scientist

About the Role

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.

Requirements & Tech Stack

• 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.

Qualifications

• 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.