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. Perform manufacturing and maintenance activities to ensure that critical manufacturing operations are on track and within budget.
RESPONSIBILITIES: Execute manufacturing activities in a safe and compliant manner. Ensure data is recorded in an ALCOA manner in the Manufacturing Batch Records (MBRs) and forms. 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. Perform front line troubleshooting of Fill finish equipment. Be part of the Total Productive Maintenance for Fill finish equipment. Coordinate with relevan...