Manager - MSAT

Summary Job Functions: Handling, supporting and executing all activities including training to subordinates for manufacturing process support and any late stage developmental work for process improvement related to Downstream process in MSAT.

Key Responsibilities:

- Execution of process scale up experiments, documentation and process improvements to support manufacturing.

- Process transfer and execution of tech. transfer with help of BBM. 

- Planning and executing experiments of DSP for process improvement, demonstrating and recording the same in proper format / report.

- Designing and execution of scale down experiments to support manufacturing for scale up. (Bag evaluation/Filter sizing/Alternate vendor evaluation etc.)

- Drafting the process related reports, protocols and IOC as a part of documentation

- Support of process transfers- Evaluation and support for implementation of new processes focusing on direct transfers

- Preparation of Qualification /verification documents (Protocols and reports) of equipment Responsible for conducting experiments to support the manufacturing team in need for any issues or improvement in the process. Both for microbial and mammalian process

- Responsible for providing shop floor support during scale up activities for engineering, CT and PPQ batches

- Ensures corporate cGMP and GLP compliance of all activities performed. 

- To follow Good Documentation Practices and Data Integrity’ requirements during any GxP Operation and recording at site. 

- To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed.

- To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP data (Records, Reports) specific to Job description.