ElevateBio

Biotechnology

BiomanufacturingAssociateII(Contract)

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

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

The Brief

“Biomanufacturing Associate II (Contract) at ElevateBio. Skills: cGMP manufacturing. Perform cGMP manufacture of cell and gene therapy. Perform aseptic processing”

Industry & Context.

Biotechnology
Problems you'll solve

Root cause analysis

Eligibility Requirements

Rotating 7 Day 12-hour shifts, Work overtime, 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, Work nights, weekends, holidays

What They're Looking For.

Must Have

Bachelor's degree in biological science, 2 years of experience in cGMP biotech manufacturing, Demonstrate proficiency in aseptic technique

Nice to Have

Experience in cell and gene therapies, Experience with CliniMACS Plus, Experience with CliniMACS Prodigy, Experience with LOVO, Experience with bioreactors, Experience with chromatography skids, Experience with TFF, Experience with WAVE bioreactors, Experience with G-Rex system

What You'll Do.

Perform cGMP manufacture of cell and gene therapy

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

Author risk assessments

Manage material ordering

Provide training to team

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

Resolve Change Controls

Generate batch records

Identify opportunities for improvements

How You'll Work.

Team & Collaboration

Cross functional teams

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, Adeno-Associated Virus (AVV) and Lentivirus (LV). The individual should be a motivated self-starter eager to contribute to building a manufacturing operation 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 and lead 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/operations start-up activities including but not limited to authoring SOPs, batch records, reports, risk assessments, material ordering/management. Provide training to team on set-up and use of equipment, process and material flows, as assigned. Ensure clean rooms are maintained in an organized and ready state. 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

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