Senior Scientist / Senior Engineer, LNP Process Development (LNP)

Location: Cambridge, Massachusetts, United States

Base salary: $145,000–$161,000 USD per year, plus annual short-term and long-term incentive awards.

Company

hirify.global is a biotechnology company developing Prime Editing gene editing therapies for genetic diseases across hematology, immunology, oncology, liver, and lung programs.

What you will do

• Lead the design, execution, optimization, characterization, and scale-up of LNP formulation and drug product manufacturing processes.
• Develop LNP mixing and tangential flow filtration processes from bench scale through GLP/GMP scale.
• Serve as an LNP process development subject matter expert across research, platform, hematology, and other cross-functional programs.
• Evaluate emerging technologies, materials, delivery approaches, and process innovations to improve efficiency, quality, manufacturability, and cost of goods.
• Support technology transfers to external CDMOs, including technical packages, on-site execution, troubleshooting, and process documentation.
• Contribute to CMC sections of regulatory filings, briefing books, and regulatory responses.

Requirements

• Ph.D. in chemical engineering, biomedical engineering, chemistry, pharmaceutical sciences, materials science, or a related discipline with 8+ years of relevant industrial experience; or an M.S. with 12+ years.
• Expertise in LNP formulation processes, TFF operations, delivery development, process scale-up, and technology transfer to GMP facilities or CDMOs.
• Proficiency with HPLC/UPLC, DLS/SLS, TEM, DSC, SAXS, UV-Vis, and fluorescence spectrophotometry.
• Experience with statistical design of experiments and knowledge of Quality by Design methodologies.
• Hands-on experience defining and setting up equipment systems for LNP and TFF processes.
• Knowledge of CMC regulatory requirements and experience contributing to IND/CTA submissions, with strong cross-functional communication and organizational skills.

Culture & Benefits

• Medical, dental, vision, and life insurance benefits.
• 401(k) match and equity programs.
• Generous paid time off, wellness days, and company-wide recharge breaks.
• Annual short-term incentive and long-term incentive awards.