OBJECTIVES:

Act as user representative/area owner in terms of technical transfer of process and product from R&D and CMC to GMP clinical manufacturing of different modalities and platforms to meet tech transfer objectives and timeline.

Provide day to day support in biologics and vaccine manufacturing operation by providing operation/maintenance input and facilitate decision making.

RESPONSIBILITIES:

• Ensure that manufacturing activities are performed in accordance to EHS guidelines and in a cGMP-compliant manner.
• Provide input to operation and equipment in the tech transfer activities of new product/process.
• Draft, author and/or provide inputs in documents consisting of but not limited to, facility fit assessment, user requirements, raw material identification, batch records, SOPs and process recipes.
• Coordinate with relevant departments and stakeholders and track progress of ...