Senior Manager

Major Purpose of the Job:

1. Responsible to deliver API (by non-infringing route for DMF) in cost effective manner in a

time bound fashion and as per marketing requirements as agreed in UID.

1. Responsible for the Transfer of the technology from lab scale to plant scale for DMF filing.
2. Responsible to address query responses and provide related supporting experimental data to

regulatory department to address the queries received from regulatory body.

1. Responsible to review the PDR, product characterization, specification and BMR in

compliance with regulatory requirements.

1. Responsible for the co-ordination with cross functional department to meet assigned tasks and

targeted timelines activities.

Principal Tasks and Responsibilities:

1. Literature search by Sci-Finder and evaluation, summary of literature search and finalization

of ROS base on cheaper and commercially available raw materials.

1. Check and define the feasibility of proposed ROS, design the experiments and optimization

of process.

1. Responsible to resolve any issues/queries related to other departments such as QA, RA,

Analytical, PE and Plant w.r.t. product process, scale-up, technology transfer, risk assessment, investigation of any failure, etc.

1. Evaluation of GTI and N-nitroso impurities in drug substance.
2. To develop cost cffective process meeting regulatory quality and minimum environmenta!