Associate Scientist/Scientist (LNP Process Development)
Science
Job Description
Associate Scientist/Scientist (LNP Process Development)
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Boston, MA
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Responsibilities:
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- Independently plan, conduct, analyze, and troubleshoot laboratory studies, using sound scientific judgment to drive projects forward.
- Develop and optimize LNP and targeted LNP formulation and synthesis methods for preclinical research, including both small-scale batches and process scale-up.
- Evaluate LNP quality attributes including mRNA encapsulation and integrity, particle size and PDI, zeta potential, ligand attachment, free ligand, lipid content, pH, osmolality, and related parameters.
- Prepare, characterize, and monitor LNP and targeted LNP materials to support internal research programs and cross-functional studies.
- Contribute to the development and qualification of analytical methods used to establish critical quality attributes for drug substances and drug products.
- Partner with internal scientists and external collaborators to support in vitro and in vivo LNP studies, ensuring materials are delivered on schedule and accompanied by appropriate characterization data.
- Communicate experimental results and scientific conclusions through technical presentations to cross-functional teams and senior leadership.
- Support technology, process, and analytical method transfers to external CDMOs and CROs.
- Prepare, review, and maintain ROPs, technical documentation, and reports supporting regulatory submissions.
- Identify experimental or process challenges and work collaboratively to develop practical solutions.
- Provide technical support, guidance, and mentorship to less experienced scientists.
- Maintain accurate experimental records, results, and supporting documentation in an electronic laboratory notebook.
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Requirements:
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- BS, MS, or PhD in Bioengineering, Chemical Engineering, Chemistry, Materials Science, Biochemistry, Biology, or a related scientific discipline, with 3+ years of relevant industry laboratory experience.
- Demonstrated hands-on experience in LNP, liposome, polymeric nanoparticle, or related formulation and/or process development.
- Practical experience with nanoparticle characterization and analytical techniques such as RiboGreen, DLS, PALS, SEC, IP-RP LC, LC-CAD, Flow NanoAnalyzer, BCA/microBCA, pH, osmolality/freezing point depression, LAL, sterility, and related methods.
- Experience manufacturing lipid nanoparticles and supporting process scale-up is highly preferred, including familiarity with microfluidic mixing, tangential flow filtration (TFF), or comparable technologies.
- Strong experimental design, data analysis, troubleshooting, organization, and project-planning skills.
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