Position Overview

We are recruiting a Scientist/Sr. Scientist with experience in phase-appropriate analytical method development, optimization, and qualification of physicochemical assays for lot release, stability, and characterization of cell and gene therapy products to support our in vivo programs using lipid nanoparticle (LNP) delivery. The Individual will work in the LNP platform analytical team and lead analytical efforts in developing early to late-phase control strategies and methods for LNP products. The ideal candidate will have experience in designing and developing analytical methods for mRNA, gRNA, lipids, and LNP, experience working collaboratively with cross-functional CMC teams and external testing labs, and working knowledge of analytical ICH/USP guidelines.

Primary Responsibilities:

• Early through late phase method development, optimization, and transfer for lot release, stability, and characterization of cell and gene therapy products and critical materials, such as gRNA, mRNA, lipids, and LNP.
• Establish technical leadership as SME in multiple analytical techniques during method development and transfer and provide technical troubleshooting support when needed.
• 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.
• 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 the 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 years (title based on experience) industry experience including biotech, biopharma, CRO, CDMO.
• Must have hand on experience on analytical method development, optimization, qualification, and testing at GMP or non-GMP environments, supporting clinical phase programs.
• A good understanding of ICH Q2 and Q14, with working knowledge on analytical Quality by Design concept.
• 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, western blotting, UV spectrophotometry, DLS, MALS, mass spectrometry, and compendial testing will be a plus.
• Experience on analytical CMC development, method transfer, stability programs, and CRO management is highly desirable.
• 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.