Scientist II, LNP, Process Development & Manufacturing

ElevateBio; Waltham (MA); On-site; USD 125,000 - 165,000; Full time

Job summary

ElevateBio is seeking a highly skilled LNP Scientist to join our process development team. The role focuses on LNP formulation and targeted LNP engineering to enable scalable manufacturing of LNP-based therapeutics.

You will design and execute formulation studies and collaborate with cross-functional teams and external clients to support development through large-scale manufacturing. The ideal candidate has hands-on LNP experience, GMP familiarity, and a track record in technology transfer and

Qualifications

• Ph.D. in Pharmaceutical Sciences or related field with 3+ years of industry LNP experience; or M.S. with 10+ years in LNP/drug delivery.
• Experience with GMP regulations, CMC, tech transfer and regulatory filings for LNP products.
• Strong LNP formulation, process development, scale-up to GMP manufacturing, and emphasis on tLNP development.

Responsibilities

• Execute LNP production to support process characterization, technology transfer, and manufacturing readiness for LNP-based drug products.
• Collaborate with cross-functional teams (MSAT, AD, Quality, Manufacturing) and external clients for process development, scale-up and tech transfers.
• Characterize LNP and tLNP formulations using analytical techniques to evaluate size, PDI, encapsulation efficiency, lipid quantification, ligand density, conjugation efficiency, and stability.
• Analyze and interpret experimental data, identify process improvements, and communicate findings and recommendations to internal and external stakeholders.

Skills

LNP formulation

tLNP engineering

analytical techniques

data analysis

process development

tech transfer

Education

Ph.D. in Pharmaceutical Sciences

M.S. in related field

Tools

PNI/Cytiva

Knauer

Tangential Flow Filtration (TFF) platforms

Job description

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.

The Role:

We are seeking a highly skilled LNP 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.

Here’s What You’ll Do:

• - Execute LNP production 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, 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.

Requirements:

Education Requirements

• - Ph.D. in Pharmaceutical Sciences, Bioengineering, Biochemistry, Chemical Engineering, Biotechnology, Biomedical Engineering or a related discipline with 3+ years of industry experience in lipid nanoparticle (LNP) development or drug delivery, or M.S degree in a related field with 10+ years of relevant industry experience . Minimum of 3 years working with LNP-based products in a process development or manufacturing setting.

Experience Requirements

• - 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.

Preferred 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.

The budgeted range for this position is $125,000 - $165,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.