ElevateBio
Biotech
Supervisor,Manufacturing
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Supervisor, Manufacturing at ElevateBio. Skills: cGMP manufacturing, People leadership. Lead cGMP manufacturing of cell and gene therapy. Perform aseptic processing”
What You'll Achieve.
Drive operational improvement
Industry & Context.
Root cause analysis
Rotating 12-hour 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, Kneel, Twist, Climb step ladders, Wear PPE, Repetitive use of arms, Repetitive use of wrist, Repetitive use of hands, Work nights, Work weekends, Work holidays, Don job-specific PPE
What They're Looking For.
Must Have
Bachelor's degree in biological science or related engineering, 4-6 years of experience in cGMP biotech manufacturing, 2+ years of experience in people leading or project leadership, Demonstrate proficiency in aseptic technique or processing
Nice to Have
Cell and gene therapies experience preferred, Experience with CART, TCR, TIL, cellular therapies, and mRNA preferred
What You'll Do.
Lead cGMP manufacturing of cell and gene therapy
Perform aseptic processing
Perform cell isolation
Perform cell selection
Perform cell culturing
Perform cell expansion
Perform cryopreservation
Perform final product visual inspection
Author risk assessments
Manage material ordering
Manage material management
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
Ensure right-first-time technology transfer
Resolve Change Controls
Ensure safety standards
Ensure quality standards
Generate batch records
Identify opportunities for improvements
Provide technical expertise
Provide organizational expertise
Provide leadership expertise
Ensure safety of assigned areas
Ensure work practices compliance
Review Job Hazard Analysis
Ensure pre-job briefs are in place
Provide daily management oversight
Ensure processes are executed with cGMP
Maintain department metrics
Report department metrics
Balance production demands
Prioritize production demands
How You'll Work.
Team & Collaboration
Cross functional teams; Process development; Facilities & engineering; MSAT; Quality control; Quality assurance
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: Lead right-first-time cGMP manufacturing of cell and gene therapy products including but not limited to aseptic processing, cell isolation, selection, culturing, expansion, harvest, cryopreservation and final product visual inspection. Lead manufacturing activities including but not limited to authoring SOPs, batch records, reports, risk assessments, material ordering/management. 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. Work effectively with cross functional teams comprised of process development, facilities & engineering, MSAT, quality control and quality assurance to ensure right-first-time technology transfer. Work with Quality Assurance and MSAT to proactively resolve issues such as deviatio
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