Executive – MSAT

Job Description

• In depth understanding of processes vial – Drug substance on mammalian/microbial based technologies.
• Monitor the manufacturing process, data acquisition, trending and analysis of manufacturing data.
• Identify areas for improvements (process efficiencies, cycle time, analytical methods variability & their impact on process etc.).
• In depth understanding of the various aspects and approaches of technology transfer, scale up principles.
• Work with R & D / Pilot plant team in execution of experimental runs and scale down experiments to support manufacturing process changes. Gain understanding of processes involved before tech transfer.
• Review of TTDs, MFRs, BPRs and any other relevant document to provide scientific inputs.
• Responsible for preparation of PPQ protocols and reports.
• Preparation of study protocols and reports, summary reports, technical reports to support manufacturing process.

• Carryout the investigations of process deviations and provide shop floor support during investigations.
• Review of process related change controls, deviations and CAPA, co-ordinate the approval process and follow up to close out. 

Work Experience

2 to 5 years of experiance 

Education

Competencies