QC Team Leader - Biologics
CK Group are recruiting for a QC Team Leader – Biologics to join The Vaccines Manufacturing and Innovation Centre (VMIC) at their site based in Oxfordshire on a permanent basis.
The Vaccines Manufacturing and Innovation Centre (VMIC) has been established to provide the UK’s first strategic vaccine development and advanced manufacturing capability. VMIC will fast track development and manufacture of early stage vaccine products, as well as serve as the UK’s response capabilityto produce vaccines against emerging infectious diseases. They have already taken a leading role in the Government’s national response to COVID-19. New starters can expect to join an exciting fast paced organisation, with ambitious growth plans. With a flat structure, employees will have exposure to senior leaders and be part of an organisation that has a start-up mentality but is backed by UK Government, and industry and academic founders. Working through collaborative ventures with industry, academia and NGOs, VMIC will ultimately strengthen and innovate the UK’s vaccines sector. Their state-of-the-art vaccines manufacturing facility will be located on the renowned Harwell Science and Innovation Campus near Didcot in Oxfordshire.Location:
This role is located in Oxfordshire where VMICs state-of-the-art manufacturing facility will be based at the renowned Harwell campus.
QC Team Leader – Biologics Role: The QC Biologics Team Leader will be responsiblefor the setting up and management of the Biologics laboratory to enable raw material and vaccine product related testing as well as WFI monitoring. The Team Leader will also lead a small team of QC Scientists to manage the sampling of raw materials and components; to organise routine and external testing; and to set up and oversee stability studies.
Your main duties will be to:
- Initially be responsible for qualification activities of the facility and utilities, participating in environmental monitoring of cleanroom areas during the performance qualification phase as well as supporting testing for the qualification of the Water for Injection (WFI), Purified Water (PW) and Clean Steam utilities.
- Establish the Biologics Quality Control department for raw material, vaccine product testing and utility monitoring (WFI) as well as sourcing, procurement, installation, and qualification of Quality Control analytical equipment.
- Establish raw material and component sampling strategy,manage sampling and testing requirements and manage/participate in routine testing in accordance with GMP regulations including starting materials, raw material, excipients, in-process and final product and stability testing.
- Direct line management including work activity and load management and performance management.
The ideal candidate for this role will have:
- A qualification at degree level or above in a scientific discipline with industrial biotech experience and strong technical knowledge of Quality Control requirements and analytical activities.
- Team management/leadership experience, including performance management and mentoring.
- Experience in OOS, non-conformances and CAPA procedures.
- Experience in starting material, raw material, in-process, intermediate, drug substance and drug product release testing as well as stability studies and ideally qualification activities.
Entitlement to work in the UK is essential. For more information orto apply for this QC Team Leader Biologics position, please contact Naynesh Mistry on 01246 457703 or email email@example.com. Please quote reference 50502.
Equal Opportunities VMIC is proud to be an equal opportunity employer. We welcomeapplications from all individuals regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any other protected characteristic. We are committed to treating all applicants fairly and without discrimination.