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

Position Overview

We are seeking a Scientist II/ Senior Scientist I with hands‑on experience in phase‑appropriate analytical method development, optimization, qualification, and transfer to support the release, stability, and characterization of cell and gene therapy products. This role will mainly support Beam’s in vivo lipid nanoparticle (LNP) based programs and will be based in a laboratory environment.

The ideal candidate will have experience in design and development of analytical methods for mRNA, gRNA, protein, protein conjugate, lipid, and LNP, experience working collaboratively with cross-functional research and CMC teams, and have a working knowledge of analytical ICH/USP guidelines.

Primary Responsibilities:

• 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 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:

• 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 (title based on experience) industry experience including biotech, biopharma, CRO, and CDMO.
• Must have hand 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 and will be key to success in this role.
• 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.
• CMC project management and people management experience will be a plus.
• Familiarity with data analysis software such as Openlab, Chromeleon, and statistical software such as JMP.
• Team player