ElevateBio

Biotech

Supervisor,Manufacturing

$0–0k Waltham, Massachusetts, United States
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“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.

Biotech
Problems you'll solve

Root cause analysis

Eligibility Requirements

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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