ElevateBio
Biotech
BiomanufacturingAssociateII(Contract)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Biomanufacturing Associate II (Contract) at ElevateBio. Skills: CGMP manufacturing, Cell therapy, Gene therapy. Perform cGMP manufacture. Review SOPs”
What You'll Achieve.
Right-first-time cGMP manufacture; Improve safety; Improve quality; Improve delivery; Improve cost
Industry & Context.
Root cause analysis
Rotating 12-hour shifts, Stand for extended periods, Walk for extended periods, Bend for extended periods, Stretch for extended periods, Carry up to 25 pounds, Carry up to 50 pounds, Push, Pull, Bend, Kneel, Twist, Climb step ladders, Repetitive use of arms, Repetitive use of wrists, Repetitive use of hands, Work nights, Work weekends, Work holidays
What They're Looking For.
Must Have
2-4 years experience, CGMP biotech manufacturing, Biological science degree, Related engineering degree, Aseptic technique proficiency, Aseptic processing proficiency, Balance multiple priorities
Nice to Have
CGMP manufacture CAR T, Process development CAR T, CGMP manufacture TCR, Process development TCR, CGMP manufacture TIL, Process development TIL, CGMP manufacture cell therapies, Process development cell therapies, CGMP manufacture mRNA, Process development mRNA, Primary cell culture understanding, Experience with BSC, Experience with Microscope, Experience with LOVO, Experience with CliniMACS, Experience with Incubators, Experience with Centrifuges, Experience with CRF, Experience with G-Rex systems
What You'll Do.
Perform cGMP manufacture
Provide input for equipment
Provide input for process
Provide input for material flows
Execute training materials
Maintain training materials
Resolve Change Controls
Execute batch records
Identify improvement opportunities
How You'll Work.
Team & Collaboration
Cross-functional teams; Quality Assurance; MSAT; Process development; Facilities & engineering; Quality control
Communication Scope
Verbal communication; Written communication
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, TILs, and mRNA. The individual should be a motivated self-starter eager to contribute to supporting a manufacturing organization 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 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 activities including but not limited to reviewing / authoring SOPs and batch records, as well as material ordering / management. Provide constructive input for the selection and set-up of equipment, process, and material flows, etc. Execute and maintain training materials and curricula that support continuous improvement in the cGMP manufacture of cell therapy products. Work with Quality Assurance and MSAT to proactively resolve issues such as deviations, CAPAs, Change Controls. Work effectively with cross functional teams comprised of process development, facilities & engineering, MSAT, quali
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