Biomanufacturing Associate II (Contract, Mon-Fri Shift)

The Role

ElevateBio is seeking a dynamic Biomanufacturing Associate II to contribute to the manufacturing operations team at our BaseCamp facility. The ideal candidate will perform routine cGMP manufacture of cell and gene therapy products, provide training, and work effectively in a cross-functional team.

Here’s What You’ll Do

• Perform and lead routine right-first-time cGMP manufacturing of cell and gene therapy products including 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 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 cleanrooms are maintained in an organized and ready state.
• 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 to ensure right-first-time technology transfer.
• Work closely with Quality Assurance and Process Sciences to proactively resolve issues such as deviations, CAPAs, Change Controls.
• 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.

Requirements

• Bachelor’s degree in biological science(s) field or related engineering with:
• 2-3+ years of experience in cGMP biotech manufacturing, preferably cell and gene therapies
• 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.

Work Schedule

• 8-hour day shifts, Monday through Friday
• Must be available to overtime on weekdays, weekends and holidays as needed.

Physical Requirements

• Routine repetitive use of arms/wrist/hands.
• Employee will frequently stand, walk, bend, and stretch for extended periods.
• Routinely carry up to 25 pounds and up to 50 pounds.
• Routinely push, pull, bend, kneel, twist, and climb step ladders while wearing PPE.

Pay

The budgeted range for this position is $38/hour - $52/hour.