Working under the direction of the Sr. Administrative Director of Therapeutic Products Program (TPP) Operations, the Director of TPP Ops Manufacturing will define the overall strategy of the core MFG group, with oversight of both the Biologics and Cell Processing Facilities (BPF and CPF). These diverse teams are responsible for the manufacture of cGMP clinical products for both internal and external clients. The TPP MFG Director will provide direct technical and managerial leadership to the MFG groups. The responsibilities of primary importance are to ensure the successful and time-sensitive GMP manufacture and release of clinical products, promoting a culture of quality and compliance, and achieving continuous improvement. The position will involve managing manufacturing operations and the supervision of approximately 25 manufacturing staff. The successful applicant will interact on a daily basis with clinical trial sponsors, QA/QC, Process Development, Process Engineering, research scientists, product management, and members of Fred Hutch faculty and administration.
The BPF performs development and cGMP manufacturing production utilizing 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 plasmids.
The CPF performs development and cGMP manufacturing production activities for cell therapy clinical trials involving the selection, genetic modification, and ex-vivo expansion of stem cells, T-cells, and B-cells.