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CMC Lead

Londres, Royaume-Uni
Assystem Energy & Infrastructure
Assystem has a vacancy for a Chemistry, Manufacturing and Control (CMC) Lead to work as part of a growing Vaccine Development team based in London
The primary role of the Vaccine Development team is to provide the technical leadership to advance our vaccines portfolio working closely with the Vaccine Science Team, partners and crosscutting teams

Location – the position is based in London with frequent international travel
Status – 1-2yrs

Key Duties

The CMC Lead reports to the Head of CMC and will be the subject-matter expert in areas pertaining to CMC and supply chain in the development of vaccines. You will support the development of the company’s portfolio of vaccine projects and the attainment of broader and longer-term goals of vaccine delivery and access, preparedness and rapid response.
You will be responsible for facilitating funded projects in a manner that guarantees clear communication and project continuity which adheres to guidelines, governance and ensures compliance with national and international regulations and current Good Laboratory Practice (GLP), Good Manufacturing Process (GMP) and current ICH guidelines.

We are looking for someone who can lead the technical CMC aspects of the projects, provide advice and support in the process development, manufacturing and supply chain oversight of these vaccines. An important area of responsibility for this role will be contributing to cross-cutting activities required to deploy investigational vaccines in emergency settings in LMICs, as well as the long-term sustainability manufacturing and supply strategy.
You will need to interact with research groups and manufacturing partners at a global and local level. Project Management and Team Leadership experience, combined with working across multinational organisations, will be critical.
• Support the development and management of the overall Chemistry, Manufacture and Controls (CMC) project strategy, development and manufacturing plan.
• Oversee the outsourced contract manufacturing and development organizations and associated timelines and budget of the awardees.
• Ensure the highest quality of CMC development and operations support is provided to all vaccine development projects in compliance with GLP, GMP, regulations and current ICH guidelines.
• Monitor timely and accurate accomplishment of key CMC project milestones and review CMC data for milestone decision processes.
• Advise on the process development, quality and supply chain of new vaccines, where requested, and guide awardees to manufacture, distribute and stockpile investigational vaccines for clinical use.
• Coordinate cross-cutting activities in CMC with stakeholders, regulatory authorities and portfolio partners, such as development of release testing specifications, development of thermostable formulations, etc.
• Support the technical evaluation and due diligence of new projects and CMC technologies in multi-functional teams as needed.

To be successful in the role you will need to demonstrate the following -:

• A proven solid working history of vaccine CMC in industry, consulting, NGO or public health sector (PhD degree preferred)
• An in-depth expertise of at least two areas of vaccine CMC (Process Development, USP, DSP, analytical, formulation, devices, GMP, QC, manufacturing, supply chain) with working knowledge of the others
• Team Leadership experience and Project Management • Regulatory experience a plus
• International experience (ideally including LMICs) and ability to work on multinational teams
• Strong communication skills
• Entrepreneurial skills

Security clearance
Whilst we encourage applications from all nationalities, Assystem within the UK are subject to security and export control restrictions due to the nature of work to be undertaken. These restrictions mean that factors including your nationality, any previous nationalities you have held, and/or your place of birth may limit those roles that you can perform for the organisation.

Direct line – 01254 927580
Mobile – 07467485141
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