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Details
Technology Transfer Specialist
Reference: | SMC37595 | Location: |
Meath |
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Technical Specialist
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 execute the transfer requirements of both late stage clinical and/or PPQ (Process Performance Qualification) programs.
- Attend meetings with local and international groups to coordinate and execute implementation tasks for new Drug Substance processes.
- Manage new program introduction schedule to ensure tasks are executed on schedule and right-first-time.
- Collaborate with stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material.
- Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes
- Employ innovative and continuous improvement mindset to identify and implement opportunities to enable product launch.
- Ensure the highest Quality, Compliance and Safety standards and embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals
- Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
- Excellent trouble shooting and problem-solving skills as well as influencing, collaboration skills and teamworking ability to work with global and interdisciplinary teams.
Education & Experience
- Minimum of 3 years of work experience in the pharmaceutical or biotech industry
- Bachelor’s degree in Engineering, Biotechnology, Chemistry, or related field.
- Technical knowledge with Biologics drug substance upstream and downstream operations or process development.
- Understanding of the principles and activities of New Product Introduction NPI/Tech Transfer
- Familiarity with the use of Automation systems in a manufacturing Process such as DeltaV, MES, eVal as well as business tools such as Power Project and Power BI.
- Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.
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