Scientist​/Senior Scientist, Analytical Development

About Gene Fab

Gene Fab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. Gene Fab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. Gene Fab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production.

Gene Fab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.

Gene Fab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. Gene Fab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. Gene Fab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production.

Gene Fab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies. We are committed to an inclusive and diverse Gene Fab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse Gene Fab team.

We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer. The Scientist/Senior Scientist in Analytical Development will assume a pivotal role within Gene Fab’s Technical Development department, executing against and supporting oversight of the analytical functions (method development, qualification, routine testing, and new technology evaluation) that are integral to the successful development and manufacturing of cell and gene therapy products for new or existing clients.

The scientist will also support activities required for GMP readiness (qualification protocol and report writing, qualification planning and strategy and method lifecycle management).

• Execute development, optimization and troubleshooting of analytical methods for cell and gene therapy products, ensuring technical excellence.
• Execute routine testing activities to support Process Development (PD), including in-process recoveries, stability studies, and cell line characterization.
• Evaluate new and innovative technologies for implementation into QC.
• Partner with MSAT on process characterization and control strategies.
• Lead assay transfer to quality control team, including writing SOPs and training QC analysts.
• Take a lead role in assay qualification activities, including partnering with QC, planning qualifications, data analysis and interpretation.
• Write qualification protocols and qualification reports in accordance to regulatory guidelines.
• Implement statistical tools and design of experiments (DOE) to ensure robustness and reliability of assays.
• Provide technical expertise and support for investigations and troubleshooting activities.
• Represent Gene Fab in analytical SME-to-SME meetings with current and prospective clients as well as in internal meetings.
• Collaborate with cross-functional teams, including scientists, engineers, and quality to support project success and timelines.
• Manage and prioritize responsibilities…