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pivotal Verified 10h ago

Associate Director/Director, Formulation & Downstream Process Development

San Diego, California, 92119, United States On-site

$120,000–$220,000 a year
Pay$120,000–$220,000
TypeFull-time
Work settingOn-site
Verified listing

JobFig found this opening at its original source and checks that it remains available.

About the role

Job Summary:  We are seeking an Associate Director/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.

What you'll bring

  • PhD. in Chemical Engineering, Biomedical Engineering, Pharmaceutics, Chemistry, Biochemistry, or a related field with 5+ years of industry experience
  • or M.S. with 8+ years of relevant industry experience, or B.S. with 10+ years of relevant experience.
  • 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.
  • Ability to work independently in the lab, manage multiple projects, and mentor junior scientists.
  • Demonstrated experience leading scientific programs and influencing cross-functional teams.
  • Experience mentoring and developing scientists.
  • Ability to establish technical strategy while remaining an active scientific contributor.