You will be responsible for executing or assigning the execution of batch records and log books, filling in various applicable formats, including line clearance and sampling formats, along with batch records review sheets.
To provide scientific support to analysts at bench level for developing & qualifying methods required for product Analytics. Execution of critical experiments for specific deliverables.
You will be responsible for generating new product ideas from Key Opinion Leaders interactions, prioritizing these ideas, preparing business cases, analyzing market and competitor data, and handling creative aspects like branding. The aim is to ensure the timely launch of products that address unmet market needs.
Experience in testing of finished products, LST and stability samples. Preferably worked in FDA Approved organizations. Hands on knowledge of cGMP, GLP, 21 CFR and any other regulatory requirements.
A Masters M.Pharm or M.Sc. or M.Tech. or M.E. or Bachelors B.Tech or B.E. or B.Pharm. An understanding of the Process Development and Industrial perspective of Biotherapeutics/ Biosimilars. Basic understanding of analytical techniques, statistical analysis, data management and analysis.
Responsible to Injectable line clearance, material verification ,start-up checks and in-process checks as per the batch manufacturing record, and Batch Packing record.