Role Summary
Principal Research Scientist I, Lipid Design and Formulations Development will lead projects focused on lipid design, formulation development, and characterization of targeted LNP drug products to support internal platform and pipeline programs. The ideal candidate will have a deep understanding of LNP formulation and lipid chemistry, analytical characterization and functional screening in vitro and in vivo. The role includes leadership of formulation projects, mentorship of team members, and contributing to regulatory filings.
Responsibilities
- Independently lead research efforts through deep technical understanding and work collaboratively within a cross-functional product development team to drive design, functional screening, development and production of novel tLNP formulations for targeted, extra hepatic delivery of nucleic acid payloads.
- Discover and optimize novel lipid designs and applications from diverse structural families for LNP platform technology development
- Collaborate with various groups across the organization including mRNA, analytical, conjugation, antibody and CMC process development groups to advance pipeline programs
- Routinely act as a group leader on formulation projects and provide mentorship to a small group of research associates.
- Contribute to formulations/process development sections of regulatory filings (IND, NDA etc.)
- Review scientific literature, patents, scientific abstracts to stay up to date on latest in the field. Provide scientific expertise in the organization with special emphasis on lipid nanoparticle-based drug targeting delivery systems for nucleic acids
Qualifications
- Required: BS or equivalent education and extensive, typically 14+ years of industry experience; MS or equivalent education with typically 12+ years of industry experience; PhD with typically 6+ years of industry experience in scientific area of discipline.
- Preferred: PhD in Chemistry, Biochemistry, Bioengineering, or Pharmaceutical Sciences with experience in the design and development of nanoparticle-based drug delivery systems or complex biologics.
- Deep technical prowess is required with respect to lipid chemistry and LNP formulation. Demonstrated ability to establish new capabilities and innovate strategies in pursuit of scientific excellence.
- Must possess in depth understanding of all aspects of formulation development as well as downstream characterization including physicochemical, stability and biological evaluation.
- Experience with process: lipid nanoparticle formulation and purification processes, and/or experience with process development, scale-up/out, engineering and GMP manufacturing of biologic drug product processes are highly desired.
- Experience with supervision, mentorship, or training of other team members.
- Good track record of scientific publications and patents in the field of lipid nanoparticle-based drug delivery systems is desired
- Must be an independent thinker with a passion for developing novel formulation technologies.
- Experience in contributing to formulation and pharmaceutical development sections of regulatory filings is highly desirable.
- Details oriented with good organization skills, great troubleshooting skills, team player, excellent oral and written communication skills are necessary for this position.