Biomanufacturing Associate II (Contract)

About the role

ElevateBio is seeking a dynamic individual to join the manufacturing operations team at our BaseCamp facility. The successful candidate will be responsible for performing and leading routine cGMP manufacture of various cell and gene therapy products.

Responsibilities

• 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 comprised of process sciences, development, facilities & engineering, tech ops, quality control, quality assurance, 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

• 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.
• Routine repetitive use of arms/wrist/hands.
• Ability to work nights, weekends, holidays as needed to support business needs.

Pay

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

Schedule

8-hour day shifts, Monday through Friday

Must be available to overtime on weekdays, weekends and holidays as needed.