What are the responsibilities and job description for the Senior Scientist position at Advanced Regenerative Manufacturing Institute Inc?
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