ElevateBio

Biotech

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, Cell therapy, Gene therapy. Perform cGMP manufacture. Review SOPs”

What You'll Achieve.

Right-first-time cGMP manufacture; Improve safety; Improve quality; Improve delivery; Improve cost

Industry & Context.

Biotech
Problems you'll solve

Root cause analysis

Eligibility Requirements

Rotating 12-hour shifts, 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, Bend, Kneel, Twist, Climb step ladders, Repetitive use of arms, Repetitive use of wrists, Repetitive use of hands, Work nights, Work weekends, Work holidays

What They're Looking For.

Must Have

2-4 years experience, CGMP biotech manufacturing, Biological science degree, Related engineering degree, Aseptic technique proficiency, Aseptic processing proficiency, Balance multiple priorities

Nice to Have

CGMP manufacture CAR T, Process development CAR T, CGMP manufacture TCR, Process development TCR, CGMP manufacture TIL, Process development TIL, CGMP manufacture cell therapies, Process development cell therapies, CGMP manufacture mRNA, Process development mRNA, Primary cell culture understanding, Experience with BSC, Experience with Microscope, Experience with LOVO, Experience with CliniMACS, Experience with Incubators, Experience with Centrifuges, Experience with CRF, Experience with G-Rex systems

What You'll Do.

Perform cGMP manufacture

Provide input for equipment

Provide input for process

Provide input for material flows

Execute training materials

Maintain training materials

Resolve Change Controls

Execute batch records

Identify improvement opportunities

How You'll Work.

Team & Collaboration

Cross-functional teams; Quality Assurance; MSAT; Process development; Facilities & engineering; Quality control

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: Perform 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 activities including but not limited to reviewing / authoring SOPs and batch records, as well as material ordering / management. Provide constructive input for the selection and set-up of equipment, process, and material flows, etc. Execute and maintain training materials and curricula that support continuous improvement in the cGMP manufacture of cell therapy products. Work with Quality Assurance and MSAT to proactively resolve issues such as deviations, CAPAs, Change Controls. Work effectively with cross functional teams comprised of process development, facilities & engineering, MSAT, quali

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