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Biopharmaceutical Manufacturing Process Specialist
2 weeks ago
We are seeking a highly skilled professional to fill the role of Senior Transfer Specialist in a Biopharmaceutical organization based in Dunboyne. This is an exciting opportunity for individuals who want to join a leading multinational company that excels in its field.
Collaborate with stakeholders to identify and execute the transfer requirements of programs. This may include late-stage clinical and/or PPQ (Process Performance Qualification)Lead meetings to coordinate activities between local and international groups for implementation of new drug substance manufacturing processesThe ideal candidate will have a minimum of 5 years of work experience in the pharmaceutical or biotech industry, including project management experience with cross-functional teams. They should also have a bachelor's degree in biotechnology, engineering, chemistry, or a related field. The following skills are required:
- Bachelor's degree in: Biotechnology, Engineering, Chemistry, or related field.
- 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
The selected candidate will be responsible for collaborating with stakeholders to deliver GMP documents related to TT, such as risk assessments, change controls, and process design documents. They will also support the development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes. Additionally, they will improve local Tech Transfer procedures to streamline and standardize New Program Introduction ways of working, while remaining compliant with the Quality Manual.
We offer competitive compensation and opportunities for professional growth and development. If you are interested in this position, please contact Seán McCarthy at sean.mccarthy@lifescience.ie for further information.