ElevateBio is powering the industry with an integrated approach to technologies and manufacturing. Backed by SoftBank VF.
About the role
ElevateBio is looking for an outstanding candidate to represent Quality Control in our Pittsburgh facility. Initially, this role will be focused on execution of the Quality Control site startup plan and associated projects needed to prepare our new facility for clinical and commercial manufacturing for US and EU markets.
What they're looking for
- Bachelor’s degree and at least 8 years of experience, OR Master’s degree with 6 years of experience, OR PhD with at least 4 years of experience
- Experience supervising teams of people
- Experience with clean room qualification per ISO 14644
- Experience with compendial safety testing as well as rapid methodologies (BacT)
- Experience with gene and cell therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays)
- Experience working with electronic systems (LIMS, CMMS, QMS, ERP)
More about this role
ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.
ElevateBio is looking for an outstanding candidate to represent Quality Control in our Pittsburgh facility. Initially, this role will be focused on execution of the Quality Control site startup plan and associated projects needed to prepare our new facility for clinical and commercial manufacturing for US and EU markets. You’ll work collaboratively with the core team, internal subject matter experts, and external project team members to develop and implement procedural changes, digital systems, and business processes at the site according to a defined project plan. This role will also assist with establishing the microbiology function in Pittsburgh to support laboratory/clean room start-up and qualification. In operation, the position will transition to oversight of quality control functions including but not limited to documents,...
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