MSAT Tech Transfer Expert
MSAT Tech Transfer Expert is a Subject Matter Expert position. His expertise includes but is not limited to tech transfer, process validation, manufacturing technologies, manufacturing environment, analytical testing and product know-How. MSAT TT expert leads product/technology transfer projects from R&D/other Lonza sites/external partners to Verviers manufacturing facility.
- Lead tech transfer projects. Ensure a proper communication between the sending party and the receiving site. Ensure that all tech transfer steps are followed per the effective tech transfer SOP.
- This includes also when necessary execution of validation tasks. Ensure validation documentation is clear, scientifically based and in compliance with European GMP, ISO13485 expectations, 21CFR820.
- This includes also supervising methodology transfer between sending party to the QC receiving department.
- Provide exhaustive planning and accurate budget evaluation for projects
- Lead technical investigations and support experiments for demonstration of potential root causes.
- Provide support to other MSAT projects.
- Keep up to date knowledge in manufacturing technologies and Science related to product
- Proven experience in tech transfer process or in cell culture media/cell therapy/pharmaceutical product manufacturing
- Experience in R&D/product development is an asset but not mandatory
- Strong scientific knowledge in cell culture is an asset but not mandatory
- High level of autonomy
- Strong analytical and problem solving skills with pragmatic approach. Proven ability to perform investigations and use root cause analysis tools
- Strong organizational skill. Ability to build accurate project planning and budget.
- Good understanding of cGMP and validation principles
- Strong knowledge of Microsoft Office software’s (Excel, PowerPoint, Word)
- Basic statistical knowledge is mandatory
- Advanced statistical knowledge is an asset
- Fluent: French and english
- Master degree Sciences, biotechnology, Chemistry or Biology