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Details
Senior Tech Transfer Specialist
Reference: | SMC37598 | 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 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
- Minimum 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
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.
Life Science Packaging Engineer Laboratory Scientist Microbiology Validation Engineer Mayo Quality Engineering Sales and Marketing Scientific Clinical Research Supply Chain Biopharmaceutical Medical Affairs Cork PhD Connected Health Academic Medical Device Manufacturing Executive Product Development Engineer Limerick Pharma Sales Diagnostics Engineering Project Manager Chemistry Supply Chain Allied Healthcare Dublin Cork City IT Academic Sales and Marketing Quality Assurance Quality Control Pharmaceutical Scientist Biotechnology
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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