About this Role:
This position is for a skilled professional who can lead the transfer of programs between different groups.
The ideal candidate will have experience with project management, quality management, and compliance systems.
They should be familiar with upstream and downstream Unit Operations for mAb manufacturing and have experience in a GMP-regulated biological drug substance manufacturing environment.
The successful candidate will be responsible for coordinating activities between local and international groups, collaborating with stakeholders to identify and execute transfer requirements, and developing process descriptions, models, and other related documents.
Key Responsibilities:
1. Collaborate with stakeholders to identify and execute the transfer requirements of programs
2. Lead tier meetings to coordinate activities between local and international groups for implementation of new Drug Substance manufacturing processes
3. Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes
4. Collaborate with stakeholders to deliver GMP documents related to TT, such as: Risk assessments, change controls, and process design documents
5. Improve local Tech Transfer procedures to streamline and standardize New Program Introduction ways of working, while remaining compliant with the Quality Manual
6. Assist in the development of future breakthrough business solutions, to reduce overall effort / reduce risk, to progress the team forward to