Biomanufacturing Associate II (Contract, Multiple Openings)

ElevateBio•Waltham, MA

1d•Onsite

About The Position

ElevateBio is seeking a dynamic individual to join and contribute to building the manufacturing operations team at our BaseCamp facility. The incumbent will 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 ideal candidate is a motivated self-starter eager to contribute to building an unparalleled manufacturing operation, possesses a willingness and aptitude for adopting new technology, can build relationships and work effectively in a cross-functional team, and is committed to the highest safety and quality standards.

Requirements

Bachelor’s degree in biological science(s) field or related engineering
2+ years of experience in project leadership is preferred.
Experience with some or all of the following: cGMP manufacture and/or process development for CAR T, TCR, NK, cellular therapies, AAV, LV, RV.
Advanced understanding of primary cell culture and experience with equipment such as CliniMACS Plus, CliniMACS Prodigy, LOVO, bioreactors (single-use and fixed-bed), chromatography skids, TFF (hollow-fiber and flat-sheet) and WAVE bioreactors such as Xuri, G-Rex system.
Outstanding communication skills (verbal and written)
Excellent computer and word processing skills including Microsoft Excel, PowerPoint, and Word.
Demonstrate proficiency in aseptic technique and/or processing.
Ability to function in dynamic environment and balance multiple priorities simultaneously.

Responsibilities

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.
Work effectively with cross functional teams comprised of process sciences, development, facilities & engineering, tech ops, quality control, quality assurance, to ensure right-first-time technology transfer.
Work closing with Quality Assurance and Process Sciences to proactively resolve issues such as deviations, CAPAs, Change Controls.
Commitment to the highest safety and quality standards in service of our colleagues and patients.
Generate and manage batch records, run reports, batch data, etc. for manufacturing and scale-up activities.
Proactively identify opportunities for improvements in process, safety, quality, and cost.