Supervisor, Cell Therapy Manufacturing

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

 

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 such as autologous/allogenic cell therapies and other advance therapies including mRNA and/or Lentiviral Vector (LLV).  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, upstream processing, downstream processing, aseptic fill finish 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, cellular therapies, AAV, LV, RV, or other biologics.
• 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, 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, stret