Senior Scientist

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. ARMI is seeking a Senior Scientist to lead the development and execution of scientific studies to facilitate the successful tech transfer, optimization, scale up, and automation of manufacturing processes for various cell-based products. The Senior Scientist will be responsible for several key areas of ARMI's scientific efforts, and this is an on-site role. 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 experience and exceptional laboratory operations and personnel management skills.

Responsibilities

Lead teams to develop and execute experimental study designs that support the development of flexible, scalable manufacturing processes

Serve as technical lead on process development activities, including technology transfer, process gaps analysis, gap-filling process development studies, scaled-up process engineering runs, and process qualifications and validations

Lead the development of written technical reports, summaries, presentations, and batch records

Lead collaboration internally and externally to achieve ARMI's technical, and strategic objectives

Requirements

Ph.D. with 5+ years of experience leading research and development projects in tissue engineering, cell, and gene therapy, or related field.

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

Skilled in mammalian cell culture technique (adherent or suspension cell culture) and aseptic processing

Experience with processes involving a variety of cell types, including Pluripotent Stem Cell expansion and differentiation

Experience leading cell culture-based experiments using bioreactors, stir-tank reactors, and microcarriers

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 GMP and/or GLP

Experience with risk management approaches such as risk assessments, corrective and preventative actions, and risk mitigation plans (preferred)

Process development or design of experiments related to cell processing scale-up (preferred)

Competency with cross-functional teamwork and professional interactions with external clients and collaborators in the cell therapy, tissue engineering, and regenerative medicine industry (preferred)

Experience in technology transfer (preferred)

Experience with Laboratory Information Management Systems, Manufacturing Execution Systems, and other enabling technology (preferred)

Ability to travel up to 10% to support tech transfer activities

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