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Senior Tech Transfer Specialist
Life Science RecruitmentMeath21 days ago
Job descriptionMinimum of 5 years of work experience in the pharmaceutical or biotech industry Bachelor’s degree in : Biotechnology, Engineering, Chemistry, or related field. 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 Experience with quality management and compliance systems. Understanding of the general principles of New Product Introduction (Tech Transfer) Familiarity with the use of Automation systems in a manufacturing Process. Competency in the use of automated / digital systems such as DeltaV, MES, eVal Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems. Validation experience including validation documentation generation and execution Familiarity with risk assessment processes
We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Dunboyne. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties
- 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 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
- Assist in the development of future breakthrough business solutions, to reduce overall effort / reduce risk, to progress the team forward to “one-click” tech transfer
- Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals
- Ensure the highest Quality, Compliance and Safety standards.
Education & Experience
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.
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Tech Transfer Specialist • Meath