Scientist/Sr. Scientist, Potency Analytical Development
3 weeks ago
Position Overview
We are seeking a motivated Scientist/Sr. Scientist to join our Analytical Research and Development team and perform 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 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:
- Perform development, optimization, robustness, and qualification of cellular and molecular assays used for lot release and characterization of cell and gene therapy products and critical materials
- Analyze, track, and trend data to monitor analytical assays, ensure consistency in assay performance, and identify assay improvements throughout the method life cycle
- Identify method improvement opportunities, and design and execute comparability studies to support method 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
- Mentor and train junior laboratory scientists
Qualifications:
- PhD in Immunology, Biological Science, Cell Biology, or related discipline with 2+ years or Bachelor's or Master's degree with 10+ years (title based on experience) of industry experience
- Must have hands on experience on analytical method development, optimization, qualification, and testing, supporting clinical phase and commercialization
- A good understanding of ICH Q2 and Q14, with working knowledge on analytical Quality by Design concept.
- Experience with MoA, functional, or potency assay development is preferred
- Team player with excellent oral and written communication skills
- Independently motivated, detail-oriented scientist with excellent critical thinking and problem-solving abilities.
- Excellent organizational skills towards multi-tasking in an extremely fast-paced environment with changing priorities.
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