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Manager, Cell Therapy Manufacturing

ElevateBio

ElevateBio

Waltham, MA, USA
Posted on Thursday, June 13, 2024

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 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

Why Join ElevateBio?

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

We aim to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision:
We seek to be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.

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.