We are recruiting a Principal Research Associate/Scientist with deep technical background in the development, optimization, and qualification of physicochemical assays for lot release, stability, and characterization of cell and gene therapy products to support Beam’s in vivo programs using lipid nanoparticle (LNP) delivery. This Individual will work in Beam’s LNP team within Analytical Development and serve as a technical leader to enable the rapid advancement of candidates from lead selection, pre-clinical development through commercialization. The ideal candidate will have experience in development and execution of analytical methods for LNP products under quality-by-design concepts, experience working collaboratively with cross-functional internal research and CMC teams (lipid optimization, LNP process analytical, characterization) and external testing labs (non-GMP batch release and stability) and have a working knowledge of analytical ICH/USP guidelines.
- Serve as lab lead and lipid/LNP analytical representative to support Beam’s internal and external development on LNP selection, optimization, production, and final DS/DP release and characterization.
- Develop, optimize, and execute analytical methods for cell and gene therapy products and critical materials, such as gRNA, mRNA, lipids, and LNP.
- Lead and execute co-qualifications at our internal testing laboratory.
- Design analytical testing plan including DOE, forced degradation, formal and informal stability studies.
- Establish technical leadership as SME in one or multiple analytical techniques during method development, qualification and transfer and provide technical troubleshooting support when needed.
- Work with cross-functional groups including LNP discovery, LNP process development, and LNP CMC team in various aspects of method development, transfer, characterization, comparability, and investigation.
- Communicate with external testing labs as analytical SME.
- Generate materials to support assay feasibility test and GMP qualification at CDMOs, CROs, and internal GMP and non-GMP labs. Contribute to technical transfer of analytical methods both internally and to external vendors.
- Coordinate routine sample testing including requests from Process Development, Research and Development groups, and external vendors.
- 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, with the potential to manage a small team of analytical scientists.
- Living Beam Therapeutics core values of being part of a community of fearless innovators, being rigorous and honest in our research, listening with open minds, and committed to each other.
- Degree in a relevant discipline (biochemistry, biotechnology, biological sciences, bioengineering, or related fields).
- Minimum 8-10 years (BS/MS) or 0-4 years (PhD) industry experience (including biotech, biopharma, CRO, CDMO) including hands on experience in cell and gene therapy.
- Hands on experience on analytical method development, qualification and analytical testing at GMP or non-GMP environments.
- Experience with analysis of RNAs, lipids, and lipid nanoparticles (LNPs) is highly desirable and will be key to the success in this role.
- Extensive experience with at least one or several of the analytical techniques is required: HPLC (IPRP, SEC, IEX), capillary gel electrophoresis, fluorescence-based RNA quantitation. Experience with qPCR, DNA and RNA extraction, ELISA, UV spectrophotometry, DLS, MALS, mass spectrometry, and compendial testing will be a plus.
- Knowledge of ICH/USP guidelines.
- People management and CMC project management experience will be a plus.
- Familiarity with data analysis software such as Empower, Openlab, Chromeleon, and statistical software such as JMP. Experience with LIMS system.
- 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.