
Ultimately responsible for all TD Operations in the Developing Markets. Supply senior TD leadership and support as appropriate to the design, construction and start-up of both Commercial Manufacturing and R&D facilities in the Developing MarketsBuild TD infrastructure to support Commercial Manufacturing and R&D activities at all Developing Markets sites. Infrastructure responsibilities include hiring and developing the appropriate staff of engineers and scientist; building the appropriate facilities in terms of process development labs, pilot plants and cGMP facilities for manufacture of Ph1/Ph2 materials (at R&D sites); and out fitting the facilities with upstream, downstream, and formulation equipment.Lead Tech Transfer Receiving Team responsible for the tech transfer of commercial products into the Developing Markets Commercial Manufacturing facilities. Developing appropriate training programs for Manufacturing Operators and QC Technicians. Working with local universities and technical institutes to develop a vaccine TD/Tech Ops talent pool.
Requirements:A Ph.D. in an Engineering or Scientific discipline or comparable experience. Must speak Mandarin and English. 10 – 15 yrs of experience in the development of Biological/Vaccine Mfg processes. Broad experience in Fermentation/Cell Culture and Downstream Purification processes. Broad experience in process scale-up and technical transfer (both internally and to 3rd parties). Proven experience in the validation of mfg processesExperienced in manufacturing Ph1/2 clinical materials.
