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About the Role
Reports to : Senior Manager, Technical Services & Validation Objectives:
- Act as tech transfer lead for process technology transfers from R&D, CMC or external collaborators to and from GMP clinical manufacturing of different modalities and platforms to meet tech transfer objectives
- Provide supports in biologics and vaccine plant start up of a start-of-the-art fill&finish manufacturing facility and operation by providing technical/SME input, audit, investigation and CAPA
- Collaborate closely with key stakeholders within GMP clinical manufacturing such as Operations (Drug Product), Engineering, Validation, QA in meeting program /tech transfer schedule
- Support as process/area owner during manufacturing scale up, optimization of drug product formulation and filling facility readiness
- Provide external contract manufacturing oversight in technical operations to achieve project deliverables and timeline
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