ElevateBio
Biotechnology
BiomanufacturingAssociateII(Contract)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Biomanufacturing Associate II (Contract) at ElevateBio. Skills: cGMP manufacturing. Perform cGMP manufacture of cell and gene therapy. Perform aseptic processing”
Industry & Context.
Root cause analysis
Rotating 7 Day 12-hour shifts, Work overtime, Stand, walk, bend, stretch, Carry up to 25 pounds, Carry up to 50 pounds, Push, pull, bend, kneel, twist, Climb step ladders, Wear PPE, Repetitive use of arms/wrist/hands, Work nights, weekends, holidays
What They're Looking For.
Must Have
Bachelor's degree in biological science, 2 years of experience in cGMP biotech manufacturing, Demonstrate proficiency in aseptic technique
Nice to Have
Experience in cell and gene therapies, Experience with CliniMACS Plus, Experience with CliniMACS Prodigy, Experience with LOVO, Experience with bioreactors, Experience with chromatography skids, Experience with TFF, Experience with WAVE bioreactors, Experience with G-Rex system
What You'll Do.
Perform cGMP manufacture of cell and gene therapy
Perform aseptic processing
Perform cell isolation
Perform cell selection
Perform cell culturing
Perform cryopreservation
Perform upstream processing
Perform downstream processing
Perform aseptic fill finish
Perform final product visual inspection
Author risk assessments
Manage material ordering
Provide training to team
Provide input on equipment selection
Provide input on process flows
Provide input on material flows
Create training materials
Maintain training curricula
Work with cross functional teams
Resolve Change Controls
Generate batch records
Identify opportunities for improvements
How You'll Work.
Team & Collaboration
Cross functional teams
Full Job Description
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. The Role: ElevateBio is looking for a dynamic individual to join and, contribute to building the manufacturing operations team at our BaseCamp facility. The incumbent will ultimately perform routine cGMP manufacture of multiple cell and gene therapy types/products at our state-of-the-art BaseCamp facility such as CAR-Ts, iPSCs, Adeno-Associated Virus (AVV) and Lentivirus (LV). The individual should be a motivated self-starter eager to contribute to building a manufacturing operation unparalleled in its capabilities and expertise, have a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functional team, and commitment to the highest safety and quality standards. Here’s What You’ll Do: Perform and lead routine right-first-time cGMP manufacturing of cell and gene therapy products including but not limited to aseptic processing, cell isolation, selection, culturing, cryopreservation, upstream processing, downstream processing, aseptic fill finish and final product visual inspection. Perform manufacturing/operations start-up activities including but not limited to authoring SOPs, batch records, reports, risk assessments, material ordering/management. Provide training to team on set-up and use of equipment, process and material flows, as assigned. Ensure clean rooms are maintained in an organized and ready state. Provide constructive input on teams for the selection and set-up of equipment, process and material flows, etc. Create and maintain training materials and curricula that support continuous improvement in the cGMP manufacture of cell therapy products
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