Scientist II/Sr. Scientist I, Analytical Research and Development

• Lead early through late phase method development, optimization, and transfer for lot release, stability, and characterization of drug substances, critical materials, and drug products
• Establish technical leadership as subject matter expert in multiple analytical techniques during method development and transfer and provide technical troubleshooting support when needed
• Work with cross-functional groups including Research & Development, Quality Control, and Process Development teams to participate in various aspects of method development, transfer, characterization, comparability, and investigation
• Coordinate routine sample testing including requests from Research and Development groups and Process Development teams
• Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions
• Analyze, track, and trend data to monitor analytical assays and ensure consistency in assay performance
• Maintaining detailed documentation of experiments in ELN system
• Adapting to a fast-paced, dynamic research environment
• Mentor and train junior scientists
• Living Beam Therapeutics core values

• Degree in a relevant discipline (biochemistry, biotechnology, biological sciences, bioengineering, or related fields)
• Minimum PhD with 2+ years or BS/MS with 10-15 years industry experience
• Must have hands-on experience on analytical method development, optimization, qualification, and testing at GMP or non-GMP environments, supporting clinical phase programs
• Experience with analysis of RNAs, proteins, protein conjugates, lipids, and lipid nanoparticles (LNPs) is highly desirable
• Extensive experience with at least one or several of the analytical techniques is required: HPLC (RP, IPRP, SEC, IEX), capillary gel electrophoresis, ELISA
• Experience with qPCR, DNA and RNA extraction, western blotting, UV spectrophotometry, DLS, MALS, mass spectrometry, and compendial testing will be a plus
• Experience with analytical CMC development, method transfer, and QC technical support is highly desirable
• A good understanding of ICH Q2 and Q14, with working knowledge on analytical Quality by Design concept
• Familiarity with data analysis software such as Openlab, Chromeleon, and statistical software such as JMP
• 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
• Must be able to work onsite daily

CMC project management and people management experience will be a plus