Principal Scientist

Job DescriptionJob Description

Overview

The Advanced Regenerative Manufacturing Institute (ARMI) is a Member-based, non-profit organization whose mission is to advance the bioeconomy of the United States. As part of its technical efforts, ARMI is applying advanced automation and analytical techniques to develop scalable, consistent, and cost-effective manufacturing processes for cells, tissues, and organs.

The Impact That You Will Make

ARMI is seeking a Principal Scientist to lead the development and execution of scientific research-focused studies to facilitate the future successful tech transfer, optimization, scale up, and automation of manufacturing processes for various cell-based products. The Principal Scientist will be responsible for several key areas of ARMI's scientific efforts and the management of a team of scientists. This is an on-site role to enable scientific discourse in real-time. The position requires excellent responsiveness to the needs of individuals and teams within ARMI and throughout its ecosystem, including ARMI's engineering partners and ARMI's Deep Tissue Characterization Center. To be successful in this role, candidates need extensive research experience, expertise in stem cell differentiation, a willingness to think outside-the-box, and exceptional personnel management skills.

Your Role

• Lead a team of scientists in the development of stem cell differentiation protocols for optimization of results and increased efficiency in the processes.
• Guide teams to develop and execute experimental study designs that support the development of flexible, scalable manufacturing processes
• Serve as technical lead on research and development activities leading to early-stage process discovery activities that will enable future technology transfer and scaled-up process engineering runs.
• Manage the development of written technical reports, summaries, presentations, and SOPs
• Lead collaboration internally and externally to achieve ARMI's technical, and strategic objectives

Your Skills and Experiences

Required

• Ph.D. with 5+ years of experience leading research and development teams and driving projects in tissue engineering, cell and gene therapy, or related field.
• Experience with Pluripotent Stem Cell expansion and differentiation.
• Red blood cell and/or pancreatic islet differentiation experience.
• Skilled in mammalian cell culture technique (adherent or suspension cell culture) and aseptic processing
• Strong verbal and written technical communication skills with both scientific and non-scientific audiences
• Demonstrated ability to lead teams to achieve strategic outcomes
• Demonstrated experience in detailed study design and reporting
• Experience with technical SOPs and master batch records

• Experience with one or more of a variety of untargeted and targeted characterization methods, including proteomics, metabolomics, lipidomics, gene expression profiling, analytical assays such as real-time PCR, ELISA, flow cytometry, and mechanical testing
• Experience with a variety of closed, scalable manufacturing systems
• Experience leading cell culture-based experiments using bioreactors, stir-tank reactors, and microcarriers Experience with GMP and/or GLP
• Experience with risk management approaches such as risk assessments, corrective and preventative actions, and risk mitigation plans
• Process development or design of experiments related to cell processing scale-up
• Competency with cross-functional teamwork and professional interactions with external clients and collaborators in the cell therapy, tissue engineering, and regenerative medicine industry
• Experience in technology transfer
• Experience with Laboratory Information Management Systems, Manufacturing Execution Systems, and other enabling technology ()
• Ability to travel up to 10% to support tech transfer activities