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Working under the direction of the Sr. Administrative Director of the Therapeutic Products Program (TPP), the Director of Manufacturing for the Biologics Processing Facility (BPF) will define the overall strategy of the department, lead a diverse set of manufacturing associates and be responsible for the manufacture of cGMP clinical products for both internal and external partners. The Director will manage and oversee staff that utilize technologies ranging from small-scale fermentation to mid-scale (130L) mammalian cell culture, protein purification and fill finish operations. The manufactured products include, but are not limited to, monoclonal antibodies, fusion proteins, viral vectors, and plasmid vaccines.
The Biologics Processing Facility Director will provide direct technical and managerial leadership to the BPF group. The responsibilities of primary importance are to ensure the successful and time-sensitive GMP manufacture and release of clinical products, promote a culture of quality and compliance, and achieve continuous improvement. The position will involve managing manufacturing operations and the supervision of approximately 6 manufacturing staff. The successful applicant will interact on a daily basis with clinical trial sponsors, QA/QC, Process Development, research scientists, project management, and senior members of Fred Hutch faculty and administration.
Specific responsibilities include:
May be required to travel on rare occasions for offsite training, customer meetings and technical transfer discussions.