Senior Scientist, LNP, Process Development & Manufacturing

ElevateBio • Waltham, MA

7d

About The Position

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. We are seeking a highly skilled LNP Senior Scientist to join our process development team at ElevateBio. The ideal candidate will have hands-on experience in LNP formulation, targeted LNP (tLNP) engineering through bioconjugation, and a complete understanding of LNP-based processes. As an LNP Scientist, you will be responsible for designing and executing LNP formulation studies while also working closely with cross-functional teams and external clients for the manufacturing of LNP-based therapeutics. Your work will be critical in advancing the translation of LNP therapeutics from development through large-scale manufacturing at ElevateBio.

Requirements

• Ph.D. in Pharmaceutical Sciences, Bioengineering, Biochemistry, Chemical Engineering, Biotechnology, Biomedical Engineering or a related discipline with 5+ years of industry experience in lipid nanoparticle (LNP) development or drug delivery, or a BS/MS degree in a related field with 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).
• Ability to analyze complex experimental data, troubleshoot process challenges, and collaborate cross-functionally with MSAT, analytical development, manufacturing, and external partners.

Nice To Haves

• 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.

Responsibilities

• Lead the execution for LNP formulation studies to support process characterization, technology transfer, and manufacturing readiness for LNP-based drug products.
• Work closely with cross-functional teams, including MSAT, AD, Quality, Manufacturing, and external clients, to support process development, scale-up and technology transfers.
• Characterize LNP and tLNP formulations using analytical techniques to evaluate size, PDI, zeta potential, encapsulation efficiency, lipid quantification, ligand density, conjugation efficiency, and formulation stability.
• Analyze and interpret experimental data, identify process improvement opportunities, and communicate technical findings, project updates, and recommendations to internal stakeholders and external clients.
• Provide strong support to the commercial team by evaluating work packages and proposals to attract potential clients looking to manufacture LNP-based drug products.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree