ElevateBio

Biotechnology

Supervisor

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

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

The Brief

“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.

Biotechnology
Problems you'll solve

Root cause analysis

Eligibility Requirements

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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