Associate II, Biomanufacturing
Core
Perform routine cGMP manufacturing of cell and gene therapy products including aseptic processing, cell isolation, culturing, and fill-finish at a state-of-the-art facility.
Role type
Associate II, Biomanufacturing IC
Builds
Cell and gene therapy products (CAR-T, iPSCs, AAV, Lentivirus)
Domain
Biopharmaceuticals / Advanced Therapies
Required skills
cGMP manufacturing, aseptic technique, cell culture, upstream/downstream processing, SOP authoring, batch record management, risk assessment, equipment operation (bioreactors, chromatography, TFF)
Preferred skills
CAR-T/TCR/NK therapy experience, AAV/LV/RV manufacturing, primary cell culture, CliniMACS/LOVO/WAVE bioreactor operation
Technologies
CliniMACS Plus, CliniMACS Prodigy, LOVO, Xuri, G-Rex, single-use/fixed-bed bioreactors, chromatography skids, TFF
Responsibilities
Execute aseptic fill-finish and final product visual inspection; Author SOPs, batch records, and risk assessments; Train team on equipment and process flows; Maintain clean room organization; Collaborate with QA/Process Sciences to resolve deviations and CAPAs; Generate batch data and run reports for scale-up activities.
Seniority
Associate II, hands-on IC