Research Associate, Analytical Research & Development

We are seeking a motivated Research Associate with cell biology experience to join our Analytical Research and Development team. The ideal candidate will work with the team to enable the advancement of cell and gene therapy candidates from pre-clinical development through commercialization. They should have a strong desire to learn about analytical assay development, including the development of novel potency assays. The primary responsibilities of this role include assisting in the development, optimization, and qualification of cell-based assays, executing characterization testing, contributing to technical transfers of analytical methods, maintaining cell lines, and contributing to authoring and reviewing SOPs, test methods, and technical reports.

• Assist in the development, optimization, and qualification of cell-based assays used for lot release and characterization of cell and gene therapy products and critical materials
• Execute characterization testing including cell-based and ELISA based potency assays, and functional assays to support Process Development studies, as well as process and product comparability and characterization studies
• Contribute to technical transfers of analytical methods both internally and to external vendors and assist in analyst training
• Maintain immortalized cell lines in culture using sterile technique to support a diverse panel of analytical assays
• Contribute to authoring and reviewing SOPs, test methods, and technical reports
• Perform data analysis and record highly detailed documentation of experiments using electronic laboratory notebook system
• Write, prepare, and present technical data to enable cross-functional understanding of analytical results

• BS in Immunology, Biological Science, Biochemical Engineering, or related discipline with 1-2 years of R&D / analytical development experience
• Broad experience with cellular and immunoassay techniques including transfections/transductions
• Ability to develop, optimize, and qualify cell-based assays for lot release and characterization of cell and gene therapy products and critical materials
• Proficiency in executing characterization testing, including cell-based and ELISA based potency assays, and functional assays
• Experience in technical transfers of analytical methods both internally and to external vendors and assisting in analyst training
• Knowledge of maintaining immortalized cell lines in culture using sterile technique
• Ability to contribute to authoring and reviewing SOPs, test methods, and technical reports
• Strong data analysis skills and ability to record highly detailed documentation of experiments using electronic laboratory notebook system
• Excellent written and verbal communication skills to write, prepare, and present technical data for cross-functional understanding of analytical results.

• Development, optimization, and qualification of cell-based assays
• Execution of characterization testing including cell-based and ELISA based potency assays
• Technical transfers of analytical methods
• Analyst training
• Maintenance of immortalized cell lines
• Authoring and reviewing SOPs, test methods, and technical reports
• Data analysis and documentation using electronic laboratory notebook system
• Preparation and presentation of technical data
• Broad experience with cellular and immunoassay techniques
• Experience with molecular assays
• Analyzing and interpreting technical data
• Troubleshooting technical problems independently
• Authoring technical reports and SOPs
• Strong team-first environment
• Adaptability to increasing scope and complexity of work
• Knowledge of ICH/USP guidelines and experience with assay qualification/validation