Research Associate, Analytical

About the Role

This role supports R&D Analytical Development to complete projects with high quality within the timeframe.

Key Responsibilities

• Perform routine scientific research tasks using standard techniques, procedures, and equipment.
• Execute experimental plans and support the investigation of technical concepts and needs.
• Perform Analytical Method development and validation for API and Formulation products, raw materials, and excipients using techniques such as HPLC, GC, etc.
• Support the performance of Analytical method transfer for Formulation projects at the manufacturing site.
• Provide on-line troubleshooting during method development and method transfer.
• Support routine analysis, experimental data generation, interpretation, and review for API & formulation analytical development.
• Interface with organizational departments in analytical method transfer of new product technology.
• Propose experimental programs and discuss with the manager/R&D engineers.
• Show analytical chemistry proficiency and use advanced analytical techniques to develop analytical testing methods for new products.
• Provide timely support to plant / Regulatory or QA in resolving analytical-related queries.
• Analyze and support in resolving research issues in a timely and accurate manner.
• Analyze development batches and routine stability samples.
• Prepare standard test procedures, SOPs, and IOPs.
• Follow cGMP compliance practices in the lab.
• Coordinate with all interfaces for support in successful product development.
• Responsible for the maintenance of assigned laboratory sections and lab work as per CGLP requirements.
• Perform general lab assignments, including analytical reagents and columns inventory management, calibration of analytical instruments, maintaining IQ/OQ/PQ documentation for analytical instruments, lab house-keeping, implementation of SOPs in R&D Labs, and updating/renewal of Annual Maintenance Contracts for analytical instruments, as assigned.
• Coordinate with team members on assigned tasks and EHS issues.
• Provide onsite or offsite support for the execution of transfer activities as per plan.
• Support in the preparation of Analytical Method Transfer documents such as Method Assessment Document, Analytical Method Transfer Plan, Protocols, and Reports, stability data, etc.

Requirements & Tech Stack

• HPLC
• GC
• IR
• Auto titrator
• MS Office (Word, Excel & PowerPoint)
• Internet Applications

Qualifications

• M.Sc. (Chemistry or its related functionary)
• Strong knowledge and understanding of analytical chemistry and various analytical techniques used in an industrial setting.
• Basic understanding of analytical method development, validation, and transfer.
• Well-versed with HPLC, GC, and other sophisticated instruments.
• Knowledge of QMS, ICH guidelines, & cGMP.
• Ability to interpret data, draw conclusions, and present results.
• Technical writing skills.