Senior Scientist, LNP, Process Development & Manufacturing
$150,000–$200,000 year
On-siteWaltham, Massachusetts, United States
Job Summary
Lead LNP formulation studies to support process characterization, technology transfer, and manufacturing readiness for LNP-based drug products. Characterize formulations using analytical techniques to evaluate size, PDI, zeta potential, encapsulation efficiency, and stability while analyzing data to identify process improvements. Collaborate with cross-functional teams, including MSAT, Quality, and external clients, to execute scale-up and technology transfers for targeted LNPs. Evaluate work packages and proposals to support the commercial team in attracting clients for manufacturing services. Requires a Ph.D. or equivalent experience, GMP knowledge, and proficiency with automated manufacturing systems.
Required Qualifications
- Ph.D. in Pharmaceutical Sciences, Bioengineering, Biochemistry, Chemical Engineering, Biotechnology, Biomedical Engineering or a related discipline
- 5+ years of industry experience in lipid nanoparticle (LNP) development or drug delivery
- BS/MS degree in a related field
- 12+ years of relevant industry experience
- Minimum of 6 years working with LNP-based products in a process development or manufacturing setting
- Familiarity with GMP regulations, regulatory expectations, and preparation of technical documentation supporting CMC activities, technology transfer, and regulatory filings for LNP-based formulated products
- Proven record of manufacturing LNP-based products through either process development work or tech transfer activities
- Strong understanding and practical experience with LNP formulation, process development, including scale-up into GMP manufacturing with demonstrated expertise in LNP formulation development & optimization, tLNP development, and LNP purification
- Ability to analyze and interpret data linking receptor engagement, ligand density, nanoparticle properties, cellular uptake, and delivery performance to guide tLNP optimization
- Experience with LNP analytical and biophysical characterization techniques such as dynamic light scattering (DLS), zeta potential, encapsulation efficiency assays (e.g., RiboGreen), lipid quantification, and stability assessments
- Experience operating automated LNP manufacturing and process development systems (e.g., PNI/Cytiva, Knauer) and filtration systems, including tangential flow filtration (TFF) platforms (e.g., Repligen)
Desired Qualifications
- Experience with targeted LNP development, including ligand conjugation strategies, functionalization approaches, and characterization of targeted delivery systems
- Experience developing analytical methods for LNP characterization and release testing, including UPLC/HPLC-CAD for lipid analysis, payload quantification, and related analytical techniques
- Working knowledge of mRNA process development unit operations including in-vitro transcription (IVT), chromatography (Affinity, RP, IEX), and integration with LNP formulation processes
- Proficiency with statistical analysis software(e.g., JMP) and experience applying Design of Experiments (DoE) approaches and data-driven approaches to LNP formulation and process development
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