Position Overview

We are seeking a motivated Research Associate / Scientist to join our Analytical Research and Development team and lead method development and qualification for lot release and characterization of cell and gene therapy products and critical materials. S/he will work with a Beam’s Analytical Development team to enable the rapid advancement of cell and gene therapy candidates from pre-clinical development through commercialization. The ideal candidate will be independent and detail oriented, have experience in design and development of novel functional cell-based and molecular assays, work collaboratively with cross-functional teams, and have a working knowledge of analytical guidelines and methods.

Primary Responsibilities:

• 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 assay improvements throughout the assay life cycle

Qualifications:

• PhD in Immunology, Biological Science, Biochemical Engineering, or related discipline with 0-2 years of R&D / analytical development experience or Bachelor’s or Master’s degree with 5-10 years of relevant experience
• Experience with MoA, functional, or potency assay development is preferred
• Excellent organizational skills and ability to multi-task in a fast-paced environment
• Team player with excellent oral and written communication skills
• Ability to critically think though experimental challenges and troubleshoot
• Knowledge of ICH/USP guidelines and experience with assay qualification/validation preferred.
• Broad experience with molecular biology, cellular, and immunoassay techniques including transfections/transductions, ddPCR/qPCR, ELISA, and IF/ICC is preferred