ElevateBio
Biotechnology
BiomanufacturingAssociate(Contract)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Biomanufacturing Associate (Contract) at ElevateBio. Skills: cGMP manufacturing, Cell therapy products. Perform routine cGMP manufacturing of cell and gene. Perform aseptic processing”
What You'll Achieve.
Right-first-time cGMP manufacturing; Proactively resolve issues; Improve safety; Improve quality; Improve delivery; Improve cost
Industry & Context.
Root cause analysis
Rotating 12-hour day shifts, Overtime on weekdays, Overtime on weekends, Overtime on holidays, 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, Wear PPE, Repetitive use of arms/wrist/hands, Work nights, Work weekends, Work holidays
What They're Looking For.
Must Have
Bachelor's degree in biological science or related engineering, 0-2 years of experience in cGMP biotech manufacturing, Demonstrate proficiency in aseptic technique and/or processing, Ability to function in dynamic environment, Balance multiple priorities simultaneously
Nice to Have
cGMP manufacture and/or process development for CAR T, TCR, TIL, cell and gene therapies, and mRNA, Understanding of primary cell culture, Experience with BSC, Microscope, LOVO, CliniMACS, Incubators, Centrifuges, CRF, and G-Rex systems
What You'll Do.
Perform routine cGMP manufacturing of cell and gene
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
Provide input for equipment selection
Provide input for process selection
Provide input for material flow selection
Execute training materials
Maintain training materials
Resolve Change Controls
Work with cross functional teams
Ensure right-first-time manufacturing
Commit to safety standards
Commit to quality standards
Execute batch records
Identify opportunities for improvements
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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