The Role:

ElevateBio is looking for a dynamic engaging leader for their cell therapy cGMP manufacturing operations. The individual will be responsible for helping to drive the on-time-delivery of manufacturing start-up activities for all aspects of cell therapy manufacturing and, contribute to on-time-delivery of manufacturing operations for ElevateBio’s multiproduct cGMP cell and gene therapy site. The incumbent will be responsible for a manufacturing team performing routine cGMP manufacture of a diverse portfolio of autologous and allogenic cell therapies at our state-of-the-art BaseCamp facility and provide leadership across both cell therapy and viral vector manufacturing. 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:

• Be a cell therapy technical expert for cGMP manufacturing and aseptic processing
• Be integral in providing hands-on technical, organizational, and leadership expertise to the start-up activity for ElevateBio’s state-of-the-art cGMP cell and gene therapy manufacturing facility including but not limited to equipment selection, SOPs, batch records, reports, risk assessments, material ordering/management
• Provide daily management oversight of product’s production flow / value stream ensuring end to end the internal supply chain delivers product timely and right-first-time, stalwart adherence to driving culture that improves operational and quality metrics
• Work with a cross-functional team of process development, engineering, quality, etc. for the development of cGMP-appropriate, scalable cell therapy manufacturing processes
• Engage in proactive relationships with partners including acting as key client interface representing ElevateBio operational interests in both tactical and strategic meetings
• Lead operational staff, develop staff capabilities, create a culture of safety, continuous improvement and training objectives, and compliance
• Establish key performance indicators in alignment with individual, department, and company goals, maintain and report organizational metrics
• Proactively identify and escalate key risks and issues to manufacturing line and site leadership team. Organize and lead ad hoc cross functional teams to develop risk mitigation plans and/or manage complex operational issues
• 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
• Identify risks and propel continuous improvements in development and manufacturing processes through technological innovation and alignment with regulatory requirements for clinical and commercial vector manufacturing
• Ensure high levels of communication with team, support resources, and management regarding issue identification and resolution; develop formal communication protocols and tools including progress tracking systems, dashboards, and management reports, and any other product specific information as needed.
• Works closely with the production staff to troubleshoot process and equipment problems
• Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet contract objectives
• Support the team in defining and executing technical strategies
• Work closing with Quality Assurance and Process Sciences to proactively resolve issues such as deviations, CAPAs, Change Controls
• Review completed batch records. Develop training material, update curricula, close training gaps, and support the initial and ongoing training of staff
• Proactively identify opportunities for improvements in process, safety, quality, and cost

Requirements:

• Bachelor’s degree in biological science(s) field or related engineering, advanced degree preferred
• A minimum of 6 years of experience in cGMP biotech manufacturing
• A minimum of 6 years of cell therapy manufacturing experience
• A minimum of 4 years of project owner/management experience
• A minimum of 4 years of proven leadership experience
• Experience with MES and integrated automation in manufacturing preferred
• Outstanding communication skills (verbal and written)
• Excellent computer and word processing skills including Microsoft Excel, Powerpoint, and Word
• Experience with some or all of the following; cGMP manufacture and/or process development for CAR T, TCR, NK, cellular therapies
• 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.

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, 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