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Process Development Senior Scientist (Stem Cell Culture, Tissue Engineering)

Company: Advanced Regenerative Manufacturing Institute Inc
Location: Manchester
Posted on: November 21, 2022

Job Description:

OverviewThe Advanced Regenerative Manufacturing Institute (ARMI) is an industry-led public-private partnership that was created to address the technical and workforce development challenges associated with the scalable, consistent, cost-effective manufacture of cells, tissues, and organs. As part of its technical effort, ARMI is developing the Tissue Foundry, an automated, modular manufacturing platform with which it will test and validate new manufacturing technologies and support the development of scalable TEMP manufacturing processes according to Quality by Design principles.Position DescriptionARMI needs a Process Development Senior Scientist to develop study designs, lead the execution of studies and perform experiments, and transition existing manual processes to fully controlled, scalable, automated and closed manufacturing processes for cells, tissues, and organs on the ARMI Tissue Foundry. The Process Development Scientist will work cross-functionally both internally and externally.Responsibilities

  • Function as technical lead on process development activities, including technology transfer, process gaps analysis, engineering runs, and process qualifications and validations
  • Develop and execute experimental study designs that support the development of flexible manufacturing processes
  • Support the development of written technical reports, summaries, presentations, and batch records
  • Collaborate internally and externally to achieve ARMIs technical, strategic objectives
  • Leading a scientific team to execute experimental designsQualifications/RequirementsRequired
    • Ph.D. 2 + years of experience in process development, tissue engineering, cell, gene therapy, or related fields.
    • Skilled in mammalian cell culture technique (adherent or suspension cell culture) and aseptic processing
    • Experience with Pluripotent Stem Cell expansion and differentiation
    • Experience running 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 experience in detailed study design and reporting
    • Ability to travel up to 10% to support tech transfer activitiesPreferred
      • Process development or design of experiments related to cell processing scale-up
      • Working knowledge of multi-omics and other analytical assays such as real-time PCR, ELISA, flow cytometry, Process Analytical Technologies (PAT) e.g. Raman or NIR
      • 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
        Additional
        • Experience with technical SOPs and master batch records, conducting process and equipment qualifications and validations
        • Experience with Risk Management approaches such as risk assessments, corrective and preventative actions, and risk mitigation plans
        • Automation of Cell Processing: Controls or system engineering experience with familiarity of:Industrial communication protocolsFamiliarity with PLC hardware/software

Keywords: Advanced Regenerative Manufacturing Institute Inc, Manchester , Process Development Senior Scientist (Stem Cell Culture, Tissue Engineering), Other , Manchester, New Hampshire

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