Scientist II, LNP, Process Development & Manufacturing (LNP)

Location: Waltham, Massachusetts, United States

Salary: $125,000–$165,000 per year

Company

hirify.global is a technology-driven biotechnology company providing integrated technologies, development services, and manufacturing expertise for advanced therapies.

What you will do

• Execute LNP production for process characterization, technology transfer, and manufacturing readiness of LNP-based drug products.
• Design and perform LNP formulation studies, including targeted LNP development and optimization.
• Characterize LNP and tLNP formulations for size, PDI, encapsulation efficiency, lipid content, ligand density, conjugation efficiency, and stability.
• Support process development, scale-up, technology transfer, and GMP manufacturing in collaboration with MSAT, analytical development, quality, manufacturing, and external clients.
• Analyze experimental data, troubleshoot process challenges, identify improvements, and communicate technical recommendations.

Requirements

• Ph.D. in pharmaceutical sciences, bioengineering, biochemistry, chemical engineering, biotechnology, biomedical engineering, or a related field with 3+ years of relevant industry experience; alternatively, an M.S. with 10+ years of relevant industry experience.
• At least 3 years of experience with LNP-based products in process development or manufacturing.
• Practical expertise in LNP formulation, process development, GMP scale-up, targeted LNP development, purification, and technology transfer.
• Knowledge of GMP regulations, regulatory expectations, CMC documentation, and regulatory filings for LNP products.
• Experience with DLS, zeta potential, encapsulation efficiency assays, lipid quantification, stability assessments, automated LNP manufacturing systems, and tangential flow filtration.
• Ability to analyze complex data and collaborate with cross-functional teams and external partners.

Nice to have

• Experience with ligand conjugation, functionalization, and targeted delivery systems.
• Experience developing LNP analytical methods and release testing using UPLC/HPLC-CAD and payload quantification.
• Knowledge of mRNA process development operations, including IVT and chromatography.
• Experience with JMP, Design of Experiments, and data-driven formulation development.

Culture & Benefits

• Regular employment within the Process Development department.
• Cross-functional work with process development, analytical development, quality, manufacturing, MSAT, and external clients.
• Opportunity to support translation of LNP therapeutics from development through large-scale manufacturing.