Granta Park, Cambridge, UK
Associate Director Project Management (CMC Team Leader)
MedImmune, the global biologics unit of AstraZeneca, is committed to developing better medicines that help people live healthier, longer and more satisfying lives. The company is focused on the areas of infection, respiratory and inflammatory disease, oncology and neuroscience, with two marketed products and a robust pipeline of promising new product candidates. MedImmune’s state-of-the-art Cambridge site (formerly Cambridge Antibody Technology) is home to around 450 employees, and serves the company’s European hub for research and development.
To lead CMC project teams in the cross-functional coordination and execution of CMC development activities. To act as Development Representative, providing strategic CMC input to Product Development Teams (PDTs) and functions, and interfacing with other project governance bodies both internally and externally as required. To ensure that CMC project deliverables are planned and achieved to agreed budget, time and quality standards.
Integrate business objectives and science.
Lead CMC Project teams for specified projects, coordinating globally across MedImmune functions (and with external suppliers as necessary) to ensure the timely development and execution of CMC activities in support of the overall Product Development Plan.
Ensure for each project that all requisite project documentation is produced and maintained to support the overall Product Development Plan and milestones. Ensure appropriate planning, and communication to enable delivery of materials and information of the required quality standard, and to identify relevant CMC activities and contingencies appropriate to the stage of the project.
Act as a ‘communication hub’ to drive project strategy at the PDT level and to agree and align any necessary changes to the CMC plans, including securing PDT, PMBO Line Management and Development Leadership team support.
Lead or participate in cross functional workstreams to establish and influence organization processes.
Collaborate with functional representatives to anticipate and identify any project risks and to ensure the production of timely and realistic action plans to resolve issues.
Ensure that all CMC activities for the projects are scheduled, coordinated and updated with the functions in a timely manner, to ensure the availability of appropriately produced and tested material which meets identified and agreed quality and project requirements.
Ensure that all relevant internal or CMO long-lead time activities are appropriately planned, scheduled and aligned with functional plans.
Initiate, manage and maintain cross-functional dependencies within the CMC project team to ensure the efficient and timely transfer of information and materials between functional groups, and to ensure that the project plan is fully integrated with other key deliverables.
Establish and maintain seamless and unambiguous communication channels to provide effective information transfer with Line Management, PMBO project managers, Development Management, and all interfacing functions and relevant governance bodies. Keep all such interfaces fully updated at an appropriate level regarding project progress, to ensure that CMC activities remain adequately focussed and on schedule, and to support any project prioritisation as required within functional areas.
PhD or equivalent in a relevant technical discipline such as Biochemistry, Microbiology or Chemical Engineering. Bachelor’s or Master’s degree with extensive experience in the CMC aspects of product development for biologicals (preferably monoclonal antibodies) and/or CMC Team leadership also acceptable. Qualifications are tradable with relevant experience.
Successful candidate must have experience in, and familiarity with, the cross functional CMC aspects (Development, Quality and Regulatory) of biopharmaceutical product development. Strongly preferred is experience in biopharmaceutical process, formulation or analytical development and demonstrated ability to lead / influence in cross functional drug development teams.
Special Skills / Abilities:
This position requires a high level of commitment and flexibility with strong skills for leadership, strategic vision, teamwork, communication and interpersonal relations. A demonstrated ability to balance and integrate business objectives and science.
This is a highly complex, visible and interactive job requiring excellent communication skills at all levels, combined with deep technical understanding, strategic vision, leadership and organization savvy.
It is expected that the successful candidate will require only a brief initial phase of orientation to specific practices, but will then quickly advance to operate with a high level of independence.
MedImmune works to boost the immune systems of babies and grown-ups. Its flagship biotech product, Synagis, prevents respiratory syncytial...