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.