Principal Research Associate/Scientist I, Analytical Research & Development

We are seeking a motivated Research Associate / Scientist to join our Analytical Research and Development team. The main responsibility of this role is to lead the development and qualification of cell and molecular assays for lot release and characterization of cell and gene therapy products and critical materials. The ideal candidate should have experience in designing and developing novel functional cell-based and molecular assays, as well as a working knowledge of analytical guidelines and methods. Additionally, the candidate will collaborate with cross-functional teams and contribute to technical transfer of analytical methods.

• Lead development, optimization, and qualification of cell and molecular assays used for lot release and characterization of cell and gene therapy products and critical materials
• Independently design and perform cell-based and molecular assays including potency assays
• Identify assay improvement opportunities, and design and execute comparability studies to support assay improvements and process improvements over the lifecycle of the product
• Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions
• Contribute to technical transfer of analytical methods both internally and to external vendors
• Work with cross-functional groups including Research & Development, QC, and Process Development teams to participate in various aspects of method development, transfer, characterization, comparability, and investigation
• Analyze, track, and trend data to monitor analytical assays, ensure consistency in assay performance, and identify areas for improvement.

• Experience in design and development of novel functional cell-based and molecular assays
• Knowledge of analytical guidelines and methods
• Ability to lead development, optimization, and qualification of cell and molecular assays
• Proficiency in independently designing and performing cell-based and molecular assays, including potency assays
• Skill in identifying assay improvement opportunities and executing comparability studies
• Experience in authoring and reviewing SOPs, technical reports, and assisting in the preparation of CMC regulatory submissions
• Ability to contribute to technical transfer of analytical methods both internally and to external vendors
• Collaboration with cross-functional groups including Research & Development, QC, and Process Development teams
• Proficiency in analyzing, tracking, and trending data to monitor analytical assays and ensure consistency in assay performance

• Lead development, optimization, and qualification of cell and molecular assays
• Independently design and perform cell-based and molecular assays
• Identify assay improvement opportunities and execute comparability studies
• Author and review SOPs, technical reports, and assist in CMC regulatory submissions
• Contribute to technical transfer of analytical methods
• Work with cross-functional groups to participate in various aspects of method development, transfer, characterization, comparability, and investigation
• Analyze, track, and trend data to monitor analytical assays and identify improvements
• Excellent organizational skills and ability to multi-task
• Team player with excellent oral and written communication skills
• Ability to critically think through experimental challenges and troubleshoot
• Knowledge of ICH/USP guidelines and experience with assay qualification/validation
• Broad experience with molecular biology, cellular, and immunoassay techniques