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Senior Research Associate, LNP Process Development

Cambridge, MA

Position Summary:

We are looking for an exceptional, enthusiastic, and highly motivated Senior Research Associate to join the Non-Viral Delivery team at Orbital. The successful candidate will work closely with the Senior Engineer of LNP Process Development to support formulation, process development, and scale-up activities for delivery matrices of nucleic acids. This role is critical for advancing Orbital's early LNP pipeline into later stages of development and manufacturing.

Responsibilities:

  • Establish, execute, and document protocols for preparation and characterization of complex formulations loaded with nucleic acid cargos for in vitro and in vivo studies.
  • Support the development and scale-up of formulations across components, mixing geometries, and payloads.
  • Design and conduct experiments to enable a robust and reproducible formulation process for clinical trial materials.
  • Design and conduct experiments to evaluate and optimize formulation stability.
  • Support technology transfer activities with CDMO and industry partners.
  • Support generation of high-quality documentation for regulatory filings and technology transfer.
  • Coordinate sample preparation and transfer with internal and external collaborators.
  • Maintain an accurate and detailed laboratory notebook and record of experiments.
  • Aid in interpretation and communication of results and actively participate in scientific discussions and group meetings.

Qualifications:

  • B.S or M.S. degree in Chemical or Biomedical Engineering or related field.
  • Must have 3-5+ years of experience. Title and scope of role will be commensurate with experience.
  • Demonstrated hands-on experience with scale-up and process development of nanoparticle formulations in an industry environment is required.
  • In-depth understanding of current methods for non-viral delivery of nucleic acids using lipid nanoparticles (LNP) is required; experience with liposomes and/or polymeric nanoparticles is a plus.
  • Familiarity with the theory and practice of controlled mixing, buffer preparation, exchange (including tangential flow filtration), and sterile filtration is required.
  • Proficiency in formulation analytics including (DLS, zeta potential, UV-Vis and fluorescence spectrophotometry, HPLC, etc.) required.
  • Prior experience with DoE and statistical software such as JMP is preferred.
  • Ability to adapt to increasing scope and complexity of work brought on by growth/change.

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