i-Pharm Consulting are recruiting for an experienced Biologics CMC (drug substance/drug product or analytics) Project Leader for a global health group operating in the vaccine development field. The role would initially be offered as a 12 month fixed term contract, with a potential to be made permanent. You can be based in the UK, East Coast of US or Norway, this position would be largely remote working with working across global regions and international travel as projects require. Due to continued growth of the organisation and department, we have an opportunity to join the group as a CMC Technology Lead within the Manufacturing and Supply Chain division. What you'll be doing... Working within the Manufacturing and Supply Chain Innovations team, you'll be working closely with the R&D Innovations office to ensure that vaccine development and manufacturing activities can support the vaccine portfolio with innovative solutions that support the mission on speed, scale and access challenges. You will be working to ensure that the right innovative technologies get developed and implemented to accelerate vaccine development in response to the next outbreak. Responsibilities: Identify innovative solutions that could make vaccine development faster, vaccine manufacturing more scalable, and/or vaccine access more equitable; and write Calls for Proposals to select partners to collaborate on these innovations Build working relationships with internationally based innovative technology partners through meetings and collaborative projects Lead technology development projects from applications, through review, due diligence and project execution to implementation of technology in a vaccine project Perform landscape analyses, identify promising innovative technologies as well as needs for innovation, connect to potential collaborators and shape projects to fill gaps Serve as contributing member on assigned long-term strategic projects - coordinating cross cutting activities with internal stakeholders, regulatory authorities and project partners Experience we are looking for: Masters degree in Biochemical Engineering, Biological sciences, Pharmaceutical Sciences or an equivalent level of experience is essential. Preference will be given to candidates who hold a PhD. Extensive experience in biologics CMC development (drug substance, drug product and/or analytical) is essential Proven experience in vaccine industry, consulting, NGO or mAb CMC experience is a must Knowledge and understanding of clinical trials, including the support of late-stage vaccine development is a plus (commercialised vaccines strongly preferred) Experience with manufacturing targeting endemic regions of low to middle-income countries is highly desirable This position is offered as an initial 12 month fixed term contract (salaried position) as such preference will be given to candidates already based in the target locations.
