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Biotech Manufacturing Process Specialist
2 weeks ago
About LSC
LSC are a leading Life Science Consultants who have a great contract opportunity for a Technology Transfer Specialist to join a biotech company based in Ireland.
Key Responsibilities:- Collaborate with stakeholders to identify and execute the transfer requirements of programs, including late stage clinical and/or PPQ (Process Performance Qualification).
- Lead tier meetings to coordinate activities between local and international groups for implementation of new Drug Substance manufacturing processes.
- 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.
We are looking for an experienced individual with:
- A minimum of 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.
Please note that for our contracting opportunities in the pharmaceutical sector in Ireland, candidates must possess either a Stamp 1G or a Stamp 4 visa.
