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Transfer Specialist
3 weeks ago
We are seeking a highly skilled Transfer Specialist to join our team in Dunboyne. This exciting opportunity involves collaborating with stakeholders to identify and execute transfer requirements for programs, including late stage clinical and/or PPQ.
The successful candidate will lead tier meetings to coordinate activities between local and international groups for the implementation of new Drug Substance manufacturing processes.
Key Responsibilities:
- Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.
- Collaborate with stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, and process design documents.
- Improve local Tech Transfer procedures to streamline and standardize New Program Introduction ways of working, while remaining compliant with the Quality Manual.
Requirements
- Bachelors degree in Biotechnology, Engineering, Chemistry, or related field.
- Minimum 5 years of work experience in the pharmaceutical or biotech industry.
- Experience with project management with cross-functional team members.
- Familiarity with upstream and/or downstream Unit Operations for mAb manufacturing.
- Competent in analyzing complex situations and showing practical problem-solving capabilities.
