Flagshippioneeringinc

Associate Director, LNP Manufacturing

Cambridge, MA USA. Posted 23 days ago

The role

This person will lead a team of scientists and engineers to ideate and build the next generation of Programmable Medicines. They will lead LNP scale-up from small R&D formulations to NHP scale and drive process development.

What you will do

  • Lead LNP scale-up from small R&D formulations to NHP scale in support of a development candidate.
  • Drive upstream and downstream process development, including mixing platforms, TFF, and freeze/storage buffer optimization.
  • Scale targeted LNPs, including conjugation, purification, and associated analytics.
  • Run micro- to mid-scale formulation on microfluidics platforms to support platform advancement.
  • Integrate QC profiling and method development into process development.
  • Lead and mentor a team of scientists and engineers.
  • Partner across departments to deliver for in vivo studies.

Required qualifications

  • Ph.D. in chemistry, chemical engineering, biochemistry, or biomedical engineering
  • Relevant industry experience
  • Hands-on experience scaling nucleic acid LNP formulations across upstream, downstream, and analytics
  • Working knowledge of mixing platforms (T-mix, impingement, microfluidics) and TFF
  • Familiarity with LNP analytical methods (DLS, HPLC/CAD, LC-MS, encapsulation assays)
  • Solid understanding of lipid and LNP design principles, stability, and their impact on critical product attributes
  • General understanding of molecular biology and nucleic acid therapeutics
  • Experience managing and mentoring research associates and junior scientists

Nice to have

  • Experience scaling in a GMP environment and managing CDMOs
  • Experience taking LNPs to the clinic, including agency interactions
  • Experience with tLNP conjugation at scale
  • Lipid synthesis, purification, and compositional analysis

Benefits

  • Healthcare coverage
  • Annual incentive program
  • Retirement benefits
  • A broad range of other benefits

About the company

Serif Biomedicines is a privately held, early-stage biotechnology company developing a novel approach to gene therapy. It was founded by Flagship Pioneering, an innovation enterprise that creates and grows life sciences companies.

Associate Director, LNP Manufacturing at Flagshippioneeringinc | JobZoey