The Role:

ElevateBio is looking for a dynamic individual to join and, contribute to leading the manufacturing operations team at our BaseCamp facility.  The incumbent will supervise routine cGMP manufacture of multiple cell and gene therapy types/products at our state-of-the-art BaseCamp facility. 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:

• Lead right-first-time cGMP manufacturing of cell and gene therapy products including but not limited to aseptic processing, cell isolation, selection, culturing, cryopreservation, and final product visual inspection.
• Lead manufacturing/operations tech transfer activities including but not limited to authoring SOPs, batch records, reports, risk assessments, material ordering/management.
• 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, MSAT, quality control, quality assurance, to ensure right-first-time technology transfer.
• Work 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.
• Be integral in providing hands-on technical, organizational, and leadership expertise to the manufacturing department including but not limited to equipment selection, SOPs, batch records, reports, risk assessments, material ordering/management.
• Ensure the safety of assigned areas and work practices in accordance with EHS program. Ensure JHA (Job Hazard Analysis) are reviewed regularly, and pre-job briefs are in place prior to execution.
• Provide daily management oversight for the team and ensure process are executed with cGMP.
• Recruit and develop staff, maintain, and report department metrics to drive operational improvement.
• Balance and priorities daily production demands to ensure right first-time execution.

Requirements:

• Bachelor’s degree in biological science(s) field or related engineering with 4-6 years of experience in cGMP biotech manufacturing, preferably cell and gene therapies.
• 2+ years of experience in people leading and/or project leadership.
• Experience with some or all of the following: cGMP manufacture and/or process development for CAR T, TCR, NK, and cellular therapies.
• Advanced understanding of primary cell culture and experience with equipment such as CliniMACS Plus, CliniMACS Prodigy, LOVO, Sepax, Rotea, G-Rex system, a plus.
• 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 support overtime on weekdays, weekends and holidays as driven by production schedule and requirements.
• Shift requirements may be subject to change based on processing needs.
• Physical Requirements:
• Employee will frequently stand, walk, bend, 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.
• Ability to don job-specific PPE.