CMC Project Manager - Hertfordshire
Jason Johal is recruiting for an experienced CMC Project Manager to join a privately-held clinical-stage biotechnology company based in the UK with sites in the US & 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. Their research is 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 and offers an excellent salary c£60,000 - £70,000 and a good benefits package.
Our client is fast progressing simultaneously several programmes towards clinical investigation and is now establishing a new Discovery Laboratory and Manufacturing Facility to ensure the rapid translation of their innovative vectors into clinic benefit. They have 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.The Role:
You will lead workstreams of late-stage CMC projects and CMC Matrix Teams for early-stage CMC projects. Serving as a core member of the CMC Matrix team and driving efficient operation of the team (including organization of meetings, agendas, preparation of minutes and maintenance of project management documentation such as decision, issue and actions logs) you will oversee day to day management of the CMC project/workstreams and provide leadership.
Providing technical input and project planning expertise to ensure operational delivery, you will create and manage the CMC project plan, identify interdependencies, maintain timelines, identify critical paths and drive delivery. You will be expected to identify opportunities to accelerate activities or to increase efficiencies and will support the technical teams to generate the required CMC data packages and ensure a robust supply chain is established.
Other duties will include budget and resource planning and tracking, contributing to the drafting of regulatory documents, identifying risks, timeline and project challenges, ensuring that projects are managed according to company Project Management standards and in compliance with the QMS and leading/supporting/driving interactions with 3rd parties as required to secure project delivery.
Coming from a scientific background and educated to degree/post-graduate level (or equivalent). You will have experience gained in the (bio)pharmaceutical/biotech industry including extensive CMC development experience (or experience of technology transfer for clinical-phase assets) and Project Management experience (or equivalent experience in a technical leadership role).
You should have worked in a cross-functional CMC team on a gene therapy, biopharmaceutical or vaccines project and will have a demonstrable understanding of the technology and technical challenges. An understanding of the drug development process from development through to market is required as are demonstrable experience of managing projects and maintaining project documentation and demonstrable matrix leadership experience and skills.
Experience with MS Project and in building detailed project plans, defining dependencies and critical path is required as is the ability to manage and track budgets and resource utilisation. Experience of drafting technical content for regulatory documents would be an advantage.
For more information or to apply for this Project Manager position, please contact Jason Johal on 01438 723 500 or 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 46011 in all correspondence.