Company Overview:
Beam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Position Overview:
We are recruiting a Senior Research Associate with a good technical background in analytical method development and sample testing for non-GMP 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 analytical platform team within Analytical Research & Development and serve as a reliable technical resource to enable the rapid advancement of candidates from IND enabling studies, clinical development through commercialization. The ideal candidate will have experience in development and execution of analytical methods for LNP products, experience working collaboratively with cross-functional internal research and CMC teams (lipid optimization, LNP process analytical, characterization) and external testing labs (non-GMP and GMP batch release and stability) and have a working knowledge of analytical ICH/USP guidelines.
Responsibilities:
- Develop and optimize analytical methods for RNA and LNP products to support Beam’s early and late phase method development requirements as well as establish platform analytical approaches.
- Execute analytical sample testing to support Beam’s internal and external development on LNP selection, optimization, production, and final DS/DP release and characterization.
- 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.
- Support 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.
- Maintain detailed documentation of experiments in ELN system.
- Live 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.
Qualifications:
- S. degree in a relevant discipline (analytical chemistry, biochemistry, biotechnology, or related fields).
- 6+ years (depending on title) industry experience (including biotech, biopharma, CRO, CDMO) with hands on experience in cell and gene therapy analytical development or QC.
- Hands on experience on analytical method development and sample 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.
- Working 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.
- 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.
