Senior Scientist, LNP, Process Development & Manufacturing

ElevateBio; Waltham (MA); On-site; USD 150,000 - 200,000; Full time

Job summary

ElevateBio in Massachusetts seeks a Senior Scientist specializing in lipid nanoparticle (LNP) formulation to join the process development team. You will design and execute LNP formulation studies, support technology transfer, and contribute to manufacturing readiness for LNP-based therapeutics.

You will collaborate with MSAT, QA, Manufacturing, and external clients, analyze results, optimize formulations, and help translate development gains into scalable manufacturing processes.

Qualifications

• PhD with 5+ years LNP development or BS/MS with 12+ years in industry
• Experience with GMP regs and CMC tech transfer
• Proven LNP formulation development and optimization experience
• Ability to link receptor engagement to delivery performance

Responsibilities

• Lead LNP formulation studies for process characterization and manufacturing readiness
• Collaborate with MSAT, AD, Quality, Manufacturing, and clients for tech transfer
• Characterize LNP/tLNP formulations using DLS, zeta, encapsulation assays
• Analyze data, identify improvements, and communicate findings to stakeholders
• Support commercial proposals by evaluating work packages for LNP manufacturing

Skills

LNP formulation

Process development

Tech transfer

GMP knowledge

Analytical methods

Statistical analysis (DoE)

Data interpretation

Cross-functional collaboration

LNP characterization (DLS, zeta)

TFF systems

Education

Ph.D. in Pharmaceutical Sciences or related

BS/MS with 12+ years experience

Tools

PNI/Cytiva

Knauer

Repligen TFF

RiboGreen assay

UPLC/HPLC-CAD

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 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.

Here’s What You’ll Do:

• 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

Requirements:

Education 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.

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 $150,000 - $200,000. This range is a good faith estimate of the expected salaryrange 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.