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Principal Scientist/Associate Director, Downstream Process Development Formulation

Pivotal Life Sciences · San Diego, California · On-site

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About Pivotal Life Sciences

Pivotal Life Sciences specializes in providing capital to innovative companies developing therapeutic products to address major unmet medical needs.

About the role

Job Title: Principal Scientist/Associate Director, Downstream Process Development Formulation About Us: A new stealth-mode biotech focused on in vivo gene editing.

What they're looking for

  • Demonstrated hands-on expertise in TFF process development for nanoparticle or biopharmaceutical applications, including membrane selection, process optimization, and scale-up
  • Direct experience with SEC or chromatographic purification of lipid nanoparticles, liposomes, or related colloidal drug delivery systems
  • Strong understanding of LNP formulation and characterization, including DLS, zeta potential, cryo-TEM, encapsulation efficiency, and particle stability assessment
  • Experience defining CPPs and CQAs for downstream processes and contributing to process characterization and validation
  • Proficiency with DOE-based experimental design and statistical analysis of process development data
  • Excellent scientific communication skills, including technical report writing, SOPs, and presentation of data to cross-functional teams
More about this role

Job Title: Principal Scientist/Associate Director, Downstream Process Development Formulation

Job Type: Full-Time

About Us: A new stealth-mode biotech focused on in vivo gene editing.

Job Summary: We are seeking an experienced Principal Scientist/Associate Director to lead downstream process development for our targeted lipid nanoparticle (tLNP) platform. This is a hands-on, lab-based role focused on the purification, concentration, and buffer exchange of tLNP drug product using size exclusion chromatography (SEC), tangential flow filtration (TFF), and complementary downstream unit operations. The successful candidate will be a technical expert in nanoparticle purification, responsible for developing robust, scalable downstream processes that deliver high-purity tLNP product while preserving particle integrity, targeting functionality, and cargo activity. This individual will also contribute to formulation development, stability assessment, and technology transfer to CDMOs. Title and salary commensurate with experience.

  • Design, optimize, and execute downstream purification processes for targeted LNPs, with emphasis on SEC (gravity flow and column chromatography, including...

Read the full posting on Pivotal Life Sciences's site ↗

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