Lead Scientist

Role & responsibilities

Research Development (Formulation)

To motivate the team to follow Good Laboratory Practice and documentation practice.

To do literature and patent search of projects.

To discuss the objective of the trial along with its data with the team with next action plan. To encourage team for healthy product discussion to meet timelines of the product.

To plan and monitor development trials along with stability batches of projects as per discussion with higher ups as per Good laboratory Practices. To check all trial details recorded in Lab Note Book.

To discuss the findings of the trials with team and compile the data of various trials.

To train team to release the required raw materials and packing materials as per system and maintain their sufficient stock.

To check RLD characterization done along with its report.

To plan the analysis of development samples/stability samples with Analytical Development Laboratory (ADL) and discuss the analytical data for any issue/concern.

To prepare the documents like BOM, MFR, stability protocol, PDR, excipient compatibility study protocol, photostability study protocol and corresponding reports.

To prepare IQ, OQ and PQ documents for equipment and qualify the equipment with corresponding reports with team.

To monitor and manufacture scale up/optimization batches, process validation batches at site along with any trouble shooting of existing products. To prepare, check and compile scale up/ technology transfer protocol with report.

To check/monitor balance / In process equipment calibration and monitor preventive maintenance activity for all equipment and instrument in lab.

To prepare and review SOP.