Team Leader, Aseptic Fill/Finish
- Experience Level
We are very proud to announce that our Manufacturing team are now hiring for our brand new Facility “Oxbox”.
This new full-service site will allow us to exploit the immediate market opportunity, meet the expected long-term demand and futureproof Oxford BioMedica’s market leading position.
As the Team Lead you will be the first in situ for our new Fill/Finish function. You will therefore support the set up and then lead a new team of aseptic filling biotechnologists, to fill, inspect and pack vector products.
Key Duties & Responsibilities:
- Ensure that all work within the manufacturing facility is carried out in compliance with the facilities GMP procedures
- Provide oversight of OXB’s routine third party manufacture of vector product.
- Co-ordinate production activities and requirements with other departments in order to achieve the production schedule, with minimal disruption to other activities within the facility
- Subject Matter Expert (SME) for Fill/Finish SOP's and batch documentation, CAPA / Dev / Change Controls and regulatory / customer GMP audits
- Accountable for the team management and performance of Fill/Finish biotechnologists
- Deputise in absence of the Aseptic Filling Production Manager for duties such as; approval on quality documents, Fill/Finish representation within internal/external meetings etc.
Required Education & Skills:
- Degree in a science based subject, and/or proven experience of manufacturing sterile drug products to EU and US standards
- Line management experience in a GMP environment
- Understanding of all aspects of sterility assurance and quality risk management.
We look forward to receiving your application
No agencies please