ElevateBio Supervisor, Cell Therapy Manufacturing in Waltham, Massachusetts
Title: Supervisor, Cell Therapy Manufacturing
Location: Waltham, MA
Reports to: Manager, Manufacturing, Cell Therapy
ElevateBio is looking for a dynamic engaging supervisor 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
Bachelor’s degree in biological science(s) field or related engineering, advanced degree preferred
4-6 years of experience in cGMP biotech manufacturing
3-4 years of cell therapy manufacturing experience
2-4 years of project owner/management experience
2-4 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, CliniMACS Prodigy, LOVO, WAVE bioreactors such as Xuri, G-Rex system
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
Why join ElevateBio?
ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities.
At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.
Our Vision: Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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