GMP Operations Manager
Mary Bolt is recruiting for a GMP Operations Manager to join a multinational clinical-stage cell & gene therapy research company focused on the development and commercialisation of gene therapies for debilitating disorders based on a next-generation AAV gene therapy platform. This is a permanent role based in Hertfordshire (20 minutes North of London via train).
The Company: The organisation has a strong reputation for their technical and strategic expertise within the cell and gene therapy market across Europe and places a strong emphasis on innovation, ability to make a difference to the patients, as well as the ability to apply your skills and develop new ones by collaborating with a multidisciplinary team. They will provide you with promising and exiting research projects in an environment that strongly values your development. Their gene therapy treatment builds upon their own pioneering work and their proprietary AAV capsid which is optimised to effectively transduce human liver cells and thus provide sustainable, high levels of the desired protein.
The Role: You will work closely with the Director of GMP Operations in the establishment and operation of the company's manufacturing capability for on-time delivery of Drug Substance for clinical supply. This will include planning for and establishing new GMP facilities and managing the project plan and work as part of a multi-disciplinary matrix team to drive on-time delivery. You will manage the production schedule by mapping out campaigns 12 months in advance to meet clinical supply demand across multiple programs. You will also be responsible for tracking open GMP Operations deviations, change controls, corrective and preventative quality and safety actions. Providing weekly status updates to GMP Operations team, ensuring actions are closed on time.
As the GMP Operations team primary point of contact for scheduling activities in the facility including material/waste transfer, equipment transfer, equipment maintenance, qualification activities etc. you will attend daily planning meetings, operations forums and steering meetings.
As the team lead for safety you will be responsible for onboarding new team members, coordinating training and site induction and maintaining accurate and up-to-date training matrix for all GMP Operations team personnel for auditing & compliance. You will also be expected to represent the company in regulatory inspections.
- Educated to degree level or equivalent in chemistry or a biological science, you will hold operations experience preferably in a manufacturing setting with experience of developing systems and processes to enable both team operation and facility operation.
- Experience of working in a continuous improvement environment/implementing lean methodologies is expected, as is strong project planning skills with familiarity with MS project and typical Project Management tools.
- You will hold a proven track record in project management for biotech/pharma development and experience leading cross-functional teams. Line/matrix management experience is a preference.
For more information or to apply for this position, please contact Mary Bolt on 01438 768717 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45685 in all correspondence.