Senior GMP Programme Manager
University of Oxford, Oxford
Senior GMP Programme Manager
£49119-£58265
University of Oxford, Oxford
- Full time
- Temporary
- Onsite working
Posted today, 26 Aug | Get your application in now to be one of the first to apply.
Closing date: Closing date not specified
Job ref: 1289b6e35f844c218ef76c69d935b793
Location ref: Oxford
Full Job Description
We are seeking an experienced and highly organised Senior GMP Programme Manager to join our friendly Pre-Clinical team and play a central role in advancing malaria vaccines and other biological investigational products through our translational pipeline. This is an excellent opportunity for a candidate with scientific skills and experience in regulated environments to lead the operational delivery of our GMP programme.
Working at the interface of laboratory science, outsourced GMP manufacture, and clinical trial delivery, you will ensure that our products move smoothly and compliantly from early development through to clinical use. You will oversee day-to-day programme activities, coordinating external CMO activities, analytical laboratories to support the delivery of high-quality materials for clinical trials.
The role will include management of GMP development and manufacturing activities, oversight of stability programmes, coordination of batch release activities, review of quality and technical documentation, and support for the management of product-related quality matters arising during the conduct of clinical trials. You will work closely with senior scientists, clinical project managers, external manufacturing partners and consultants to deliver high-quality materials for clinical trials. This is a role requiring technical and scientific experience, excellent organisational skills and the ability to work effectively across multiple stakeholders.
You will be working in a growing department within the Medical Sciences Division. The Department of Paediatrics is a world leader in child health research and hosts internationally renowned research programmes in drug development, gastroenterology, haematology, HIV, immunology, neuroimaging, neuromuscular diseases and vaccinology. Please visit the Draper Lab website to find out more about the group.
The University of Oxford is committed to equality and valuing diversity. All applicants will be judged on merit, according to the selection criteria.
This position is offered full-time on a fixed-term contract initially 24 months with the possibility to extend provided further external funding is available. Part-time applications may be considered (with a minimum of 30 weekly hours).
About the department
The Department of Paediatrics has been honoured with the Athena Swan Gold award, a national gender equality charter, recognising the Department's innovative policies and practices. We are committed to the professional development of our staff by providing up to ten paid days annually for skill enhancement and allowing applications for additional training funding. By joining us, you will have the opportunity to contribute to a forward-thinking department.
We welcome new staff with ideas who are willing to shape the future of the department that thinks about its staff and wellbeing. In addition to the University of Oxford healthcare and wellbeing resources, the Department of Paediatrics sponsors weekly exercise classes such as yoga and bootcamp sessions as well as a choir. For staff on work visas, we also offer financial assistance towards visa renewal fees. These activities are designed to promote physical and mental wellbeing among staff members.
Please visit our website to find out more about the Department.
You will have a scientific degree in a relevant subject area with significant experience delivering scientific or technical projects in a regulated GMP/GxP environment. You will have a strong working knowledge of GMP for IMPs, confidence with managing external relationships and of delivering projects on time and within budget. You will be highly organised, have good interpersonal skills and be able to interact productively and collaboratively with other team members. Good communication skills and the ability to work as part of a team are essential.