Senior Scientist, LNP Process Development (Gene Editing Delivery)
Biotechnology company developing one-time gene editing therapies, Cambridge, MA
| Employer | Biotechnology company developing one-time gene editing therapies, Cambridge, MA (not named) |
|---|---|
| Location | Cambridge, MA (Boston) · On-site |
| Type & level | Full-time · Senior |
| Pay | USD 145k–161k base Source: pay range stated in the source posting |
| Visa path | O-1A fit (senior candidates) |
| Role family | Gene Therapy / CRISPR Scientist |
About the role
This role leads the development and scale-up of lipid nanoparticle formulation and drug product manufacturing for gene editing therapy programs. The scientist takes processes from bench to GLP/GMP scale and supports transfer to external manufacturers. The role exists to make delivery of novel editing modalities robust, manufacturable and ready for clinical use.
What you'll do
- Design, run and optimize lipid nanoparticle mixing and tangential flow filtration processes from bench through GLP/GMP scale.
- Act as the process development expert across several programs, working with research and platform teams to turn new modalities into developable drug products.
- Evaluate new materials, delivery approaches and process innovations that improve delivery efficiency, product quality and cost of goods.
- Support technology transfer to contract manufacturers, including transfer packages, on-site support and troubleshooting.
- Write the CMC sections of regulatory filings, briefing books and regulatory responses for the lipid nanoparticle drug product.
- Keep thorough electronic notebook records and write protocols, SOPs, development reports and technical reports.
Requirements
- Ph.D. in chemical engineering, biomedical engineering, chemistry, pharmaceutical sciences, materials science or a related field with 8+ years of industry experience in lipid nanoparticle process and formulation development, or an M.S. with 12+ years.
- Proven expertise in lipid nanoparticle formulation processes, tangential flow filtration and related characterization methods.
- Hands-on experience scaling processes from bench to GLP/GMP scale and transferring them to GMP facilities or contract manufacturers.
- Strong skills in analytical methods such as HPLC/UPLC, DLS/SLS, TEM, DSC, SAXS, UV-Vis and fluorescence spectrophotometry.
- Experience with statistical design of experiments and Quality by Design, plus knowledge of CMC requirements for IND/CTA submissions.
- Clear communicator who can set priorities across competing demands.
Nice to have
Pay & benefits
USD 145k–161k base. The posting lists medical, dental, vision, life insurance, a 401(k) match, equity programs, generous paid time off, wellness days and company-wide recharge breaks. The role is also eligible for an annual bonus and long-term equity award.
Pay source: pay range stated in the source posting. Market data, not an offer from O1DMatch.
Visa path
People in senior gene-editing delivery roles typically support an O-1A case with a publication and patent record, peer review or invited talks, and evidence of a critical role on clinical-stage programs. They may also show high pay relative to peers. The posting states no citizenship restriction. An employer like this, or a U.S. agent, can file the petition, though approval depends on the individual's evidence.
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