Director, Nanotechnology
San Diego, CA Preclinical
Description

Your Impact

Our Gene Therapy Program aspires to develop single treatment disease cures utilizing Poseida’s best-in-class gene editing tools including piggyBac® and cas-CLOVER™. As an integral participant in this effort, you will utilize your skills as a leader and formulation chemist in collaboration with a multidisciplinary team of innovative, enthusiastic, and highly self-motivated scientists to develop non-viral nanotechnologies like lipid nanoparticles to safely and efficiently deliver nucleic acids to target cells in afflicted patients. Your participation will have a direct impact on Poseida’s efforts to cure challenging diseases, including Hemophilia, by expanding the reach of our platform technologies.


Job Summary

Poseida Therapeutics, is searching for an outstanding Associate Director/Director to join our In Vivo Gene Therapy group in San Diego, CA. This position offers an exciting opportunity to lead an effort to develop non-viral delivery tools for genome editing and gene therapy applications. This person will manage the day-to-day formulation development activities and provide strategic guidance towards discovering novel nucleic acid delivery technologies while collaborating with internal molecular biology, pharmacology, synthetic chemistry, and process development teams.


Responsibilities 

These include but are not limited to:

  • Lead lipid nanoparticle (LNP) formulation early process development and analytical characterization efforts to provide reproducibly efficacious in vivo delivery of Poseida Therapeutic’s proprietary gene insertion/editing systems in support of non-GLP, preclinical studies
  • Serve as Poseida’s Subject Matter Expert (SME) for the manufacture, scale-up, and analytical characterization of LNPs and other non-viral formulations
  • Design, implement, and execute early process development/CMC activities for lipid nanoparticles (LNPs)
  • Lead DoE-based screening campaigns directed towards optimizing LNP manufacture and scale-up
  • Set raw material specifications and determine LNP CQA
  • Identify and manage suitable CROs and CDMOs for LNP manufacture and analysis
  • Actively collaborate with Process Development team to identify in-house opportunities to manufacture LNPs for preclinical GLP studies
  • Take responsibility for the ensure timely technology transfer of LNP manufacture and analysis protocols to CROs, CDMOs, and corporate partners
  • Work collaboratively with Synthetic Chemistry, Formulation Discovery, and Process Development Teams to maintain formulation development workflow and provide study materials in a timely manner
  • Provide strategic input and contribute intellectually to Poseida’s formulation discovery effort
  • Critically review and analyze data, and communicate results and conclusions; present and defend ideas in cross-functional meetings
  • Author study design protocols, technical reports, technology transfer documentation, and contribute to regulatory filings
  • Build-Poseida’s formulation development capabilities and team
  • Supervise and mentor 4-6 Scientists and/or Research Technicians/Assistants
Requirements

Requirements, Knowledge, Skills and Abilities:

  • Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, Process Engineering or related discipline with 8-plus years (12-plus years for Director) of relevant, post-graduate, nucleic acid formulation experience
  • A minimum of 7-years’ experience in generating LNPs or related non-viral nucleic acid delivery technologies in a preclinical industry setting using state-of-the-art manufacturing methods like advanced microfluidics, T-mixing, and tangential flow filtration (TFF) is a must
  • 2-plus years (4-plus years for Director) of direct management experience and a track record for developing young talent
  • SME in preparing, characterizing, and scaling-up LNPs for in vivo applications as demonstrated through publication record, patent filings, and/or work in a relevant drug development setting is required
  • Experience using design of experiment (DoE) and relevant statistical software packages (JMP) for formulation discovery
  • Hands-on expertise in basic analytical and biophysical methods used for the characterization of nanoparticle formulations, particularly size, morphology, zeta potential, and nucleic acid encapsulation/release (i.e., DLS, fluorescent assays, HPLC/UPLC, etc)
  • Experience working with and managing CROs and CDMOs
  • Previous experience with IND submissions involving LNPs is desirable
  • Familiarity with in vivo pharmacology and ADMET concepts as they relate to nucleic acid nanoparticle drugs
  • Experience using predictive data analysis, computational methods/software, and machine learning for formulation and/or drug discovery is a plus but not required
  • Established track record of supervising/mentoring junior researchers
  • Must be self-motivated and experienced in optimizing and advancing LNP formulations within a multidisciplinary team environment with scientists and external collaborators