ElevateBio
Biotechnology
Supervisor
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Supervisor at ElevateBio. Skills: cGMP manufacturing, People leadership. Lead cGMP manufacturing of cell and gene therapy. Lead manufacturing activities”
What You'll Achieve.
Drive operational improvement
Industry & Context.
Root cause analysis
Rotating 12-hour shifts, Overtime availability, Weekend availability, Holiday availability, 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, Don job-specific PPE
What They're Looking For.
Must Have
Bachelor's degree in biological science or engineering, 4-6 years experience in cGMP biotech manufacturing, 2+ years experience in people or project leadership, Proficiency in aseptic technique and/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
Lead manufacturing activities
Author risk assessments
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
Generate batch records
Identify opportunities for improvements
Provide technical expertise
Provide organizational expertise
Provide leadership expertise
Ensure safety of assigned areas
Ensure work practices in accordance with EHS program
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 daily production demands
Prioritize daily production demands
Ensure right first-time execution
How You'll Work.
Team & Collaboration
Cross functional teams; Quality Assurance; MSAT; Process development; Facilities & engineering; Quality control
Communication Scope
Verbal communication; Written communication
Process & Methodology
Project leadership
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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