Senior Director, Cell Therapy R&D & Process Development

Overview

The Advanced Regenerative Manufacturing Institute (ARMl)
IBioFabUSA is a Member-based non-profit, member-driven, public-private partnership with a mission to advance the bioeconomy and transform the future of human health. ARMI provides technical and wrap-around commercialization services to companies seeking to advance technologies that will contribute to this impact.

Overview

The Advanced Regenerative Manufacturing Institute (ARMl)
IBioFabUSA is a Member-based non-profit, member-driven, public-private partnership with a mission to advance the bioeconomy and transform the future of human health. ARMI provides technical and wrap-around commercialization services to companies seeking to advance technologies that will contribute to this impact.

The Impact That You Will Make

ARMI is seeking an independent, self-starter with experience overseeing diverse research teams including analytical and early-stage process development focused on advancing cell therapies. The successful candidate will be responsible for oversight of R&D activities, management of personnel to ensure milestones and timelines are met, and collaboration with leadership to develop study plans and hypotheses. This individual will lead a team of scientists and lab technicians to develop early phase manufacturing processes and analytical assays as part of grant programs, for internal transfer, or in collaboration with external parties.

This role requires particularly strong attention to detail, a deep understanding of analytical tests, extensive experience with stem cell biology, and the ability to think outside the box to solve problems creatively and proactively. The ideal candidate will have experience with hPSCs, cell and tissue engineering, flow cytometry, RNASeq, assay development, ELNs, SOP drafting, root-cause analysis, and other documentation.

Your Role

Leadership and Oversight

• Lead daily R&D operations/tasks.
• Ensure team compliance with GLP and safety standards.
• Coach team members on root-cause analysis, documentation, and CAPA.
• Collaborate with cross-functional teams including Quality, Facilities, and Project Management.
• Manage multiple projects simultaneously and confidentially while meeting critical timelines and deliverables.
• Work with management to develop robust, well controlled, hypothesis driven research.
• Support internal tech transfer and client interactions as needed.
• Manage external communications on projects as needed.

• Conduct technology transfers within ARMI's facility.
• Draft and review/approve accurate SOPs, technical documentation, ELN entries, and detailed reports as needed.
• Monitor research progress through experimental design and data analysis.
• Troubleshoot issues, perform root cause analysis, and implement corrective actions.

• Collaborate with Operations, service engineers, and vendors for process equipment, calibration, preventative maintenance, optimization, and upgrades.
• Ensure proper training of laboratory personnel on process and safety procedures.

• Biotechnology, Biology, Biochemistry, or related life science degree. PhD with 4-6 years of experience in human stem cell biology, tissue engineering, and/or analytical assay development.
• Familiarity with phase appropriate GMP and relevant FDA regulations and requirements.
• Demonstrated experience leading teams and cross-functional interactions.

• Extensive cell biology experience
• Experience with process equipment including a variety of cell culture technologies from flasks to stirred tank reactors, counter flow and continuous centrifugation, etc.
• Experience with ELN, data analysis software (e.g., Graph Pad, JMP), and statistical methods…