Executive- Formulation tech transfer / PDL / MSAT

Job description

Role & responsibilities

• To receive and understand the technology from FnD dept.
• To design optimisation for process parameters & participate in the trials at R&D.
• To transfer the technology from R&D to receivers site for the respective product.
• To monitor the TT demo / exhibit / scale up and optimization batches.
• To review the technical information sheet, product detail, raw material / accessories / equipment requirement for plant trial / SU / Exhibit batches.
• To propose and fix the batch size i.e. of the Demo, Scale up, Exhibit and Commercial based on Equipment Capacity / Qualification, Scale Up factor calculations & annual requirements.
• To get involved and observe in the TT demo batch with F&D.
• To take scale up batch at manufacturing locations and prepare scale up batch protocol, Scale Up Reports, MFC, Sampling Protocol, Risk Assessment etc.
• To take the exhibit batches at the manufacturing locations and take care for its trouble shooting.
• To prepare the summary reports.
• To perform investigation for Deviation / OOS / OOT observed during SU / EB at plant. To prepare agency  query responses.

Skills Required

it optimisation , Mfc