GMP Operations Manager
An international biotechnology company is recruiting a GMP Operations Manager to their UK office. The organisation focuses on gene therapy to treat the suffering of people suffering from chronic systemic diseases. With a next-generation gene therapy platform to provide treatments for a wide range of diseases, this position represents an exciting opportunity to work with a leading company.
- Work closely with the Dir. GMP Operations in the establishment and operation of company manufacturing capability within the CGT-MC for on-time delivery of Drug Substance for clinical supply.
- Work closely with the Dir. GMP Operations in planning for and establishing new GMP facilities.
- Manage the project plan and work as part of a multi-disciplinary matrix team to drive on-time delivery.
- Manage the production schedule, maintenance schedule, and annual facility shutdowns.
- Map out campaigns 12 months in advance to meet clinical supply demand across multiple programs.
- Act as the GMP Operations team primary point of contact with CGT-MC for scheduling activities in the facility, including material/waste transfer, equipment transfer, equipment maintenance, qualification activities etc.
- Attend daily planning meetings, operations forums, and steering meetings with CGT-MC.
- Act as the team lead for safety in both internal and CGT-MC for a.
- Coordinate and lead GMP Operations daily, weekly, and steering meetings, setting agenda, capturing actions, and tracking completion.
- Be responsible for maintaining accurate and up-to-date training matrix for all GMP Operations team personnel and auditing for compliance.
- Be responsible for onboarding new team members, coordinating training and site induction.
- Be responsible for tracking open GMP Operations deviations, change controls, corrective and preventative quality and safety actions.
- Provide weekly status updates to GMP Operations team, ensuring actions are closed on time.
- Act as a key senior team member, working closely with technical managers and supply chain managers in GMP Operations, QA, QC, and and equivalent functions within CGT-MC.
Skills and Requirements:
- Educated to degree level or equivalent in chemistry or a biological science.
- Operations experience, preferably in a manufacturing setting with experience of development of systems and processes to enable both team operation and facility operation.
- Experience of working in a continuous improvement environment/implementing lean methodologies.
- Proven track record in project management for biotech/pharma development.
- Line/matrix management experience.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Joshua Godden at + 442038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.