MSAT Technology Transfer support
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
For our site in Verviers, Belgium | Lonza we are looking for a MSAT Tech transfer support which is a Subject Matter Expert position. Scope of responsibilities is linked to Tech Transfer process of a new/modified product. His responsibilities includes creation and management of documents (DMR, recipes, process instructions, etc) related to the introduction of a new product or a modification of an existing product. His responsibilities includes supervising tech transfer of products developed within Lonza.
Supervise tech transfer projects linked to Lonza products internally developed. 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 support to the Tech Transfer associate position:
for new bulk setup (Bulk BOM, filtration assessment, Bioburden category, SAP recipes, PI-sheet, chemistry protocols, commodity-tarif codes with Trade Compliance Group, Product Safety Form with Global Product Safety team)
Set up stability studies and follow up
Monitor the progress of approval work flow to ensure that all items pertaining to his responsibilities move through the designated approval streams to meet GMP requirements
Collaborate with finance to ensure Bill of Materials are entered correctly into financial system (SAP)
When applicable, assess the production feasibility and calculate costings in collaboration with Master data team
When applicable, responsible for deactivation/reactivation and discontinuation of parts in the ERP system
When applicable, responsible for changes within the SAP system in the scope of his responsibilities
Manage, maintain, improve SOPs related to his scope of responsibilities
Proactively identify and implement workflow process improvements to improve lead time and facilitate Operational Excellence.
Bachelor or Master in a scientific domain
General scientific knowledge in GMP manufacturing process is a must
High level of autonomy
Strong analytical and problem solving skills with pragmatic approach.
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 in French and English
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.