Jason Johal is recruiting for a CMC External Supply Manager to join a privately-held clinical-stage biotechnology company based in the UK and in Europe whose vision is to create better lives for people suffering from chronic systemic diseases using the potential of gene therapy as a one-off curative treatment. This is a permanent role based in Hertfordshire and offers an excellent salary c£60,000 and a good benefits package.
Our client has a clear focus on AAV-based gene therapy targeting the liver with the aim to provide treatments for diseases with significant unmet needs. Their gene therapy treatment builds upon pioneering work, which has already transformed the lives of patients by providing safe, effective and reliable gene therapy for people with Haemophilia B.
You will oversee day to day management of technology transfers to external parties, ensure ongoing compliant supply, track budgets, plan & ensure secure compliant supply of critical materials for the company portfolio (both internal & external GMP production) and identify & document potential risks and mitigations. You will lead the technology transfer team whilst playing a key role in CMC matrix teams delivering the overall CMC/supply for company development projects and act as technical/supply lead for post-tech transfer projects. You will also produce and distribute status, resourcing, and tracking reports and will be expected to provide manufacturing support & trouble-shooting (across all stages of manufacture including aseptic processing and fill/finish) for investigation of process failures, quality incidents, deviations, corrective/preventative action plans, and change controls. Another key aspect will be working closely with cross-functional teams focusing on continuous improvement and operational excellence, improving efficiency and effectiveness
You will have knowledge and experience of bioprocess development, scale-up and GMP manufacturing (including large scale mammalian cell culture support) along with experience in biopharmaceutical/biologics manufacturing and/or process development/scale-up. Experience of developing robust and scalable GMP compliant processes for either gene therapy, viral vectors, vaccines, or biological products; including knowledge spanning upstream; downstream and fill/finish technologies is also required. As is, experience of technology transfer, management of CRO's/CMOs and/or GMP manufacturing, providing technical expertise to assist troubleshooting issues, during technical transfer or routine production, knowledge of quality management , regulatory requirements and CMC development. A comprehensive understanding of the drug development process from development through to market are also required and a demonstrable ability to work in and lead multi-disciplinary, multi-cultural teams and work effectively with partners plus the ability to travel to work partners in Globally as the role requires are also required.
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 ST42804 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Jason Johal
- Phone: 01438 723 500
- Reference: ST42804
- Posted: 13th July 2018
- Expires: 10th August 2018