Lead Downstream Scientist, Lipid Nanoparticle Purification

Pivotal Life Sciences; San Diego (CA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Competitive salary

Equity

Professional growth opportunities

Job summary

Pivotal Life Sciences in San Diego is seeking a Principal Scientist/Associate Director to lead downstream process development for our targeted lipid nanoparticle platform. You will purify, concentrate, and buffer-exchange LNPs using SEC and TFF, while preserving particle integrity and cargo activity.

The role involves formulation development, stability assessment, technology transfer to CDMOs, and active collaboration with cross‑functional teams. Title/salary commensurate with experience.

Qualifications

• Hands-on experience with TFF process development for nanoparticle applications.
• Experience with SEC or chromatographic purification of lipid nanoparticles.
• Strong understanding of LNP formulation and characterization techniques.
• Ability to define CPPs and CQAs for downstream processes.

Responsibilities

• Design, optimize, and execute downstream purification for LNPs using SEC and TFF.
• Develop and optimize TFF operating parameters to maximize recovery and minimize stress.
• Establish SEC methods to separate assembled tLNP from impurities.
• Characterize intermediates and final product using DLS, zeta potential, NTA, cryo‑TEM.
• Lead formulation and buffer exchange optimization for tLNP stability.
• Support tech transfer to CDMOs with documentation and on-site support.
• Collaborate with formulation, analytical, and biology teams to preserve integrity.
• Plan DOE studies to optimize purification and formulation parameters.
• Contribute to regulatory filings (IND/CTA) for downstream CMC sections.

Skills

Downstream process development

LNP purification

DOE design

Process characterization

Regulatory readiness/IND-CTA

Tech transfer to CDMOs

Collaboration across teams

Mentoring juniors

Education

PhD in Chemical/Biomedical Engineering or related

MS in related field

BS in related field

Tools

CIMmultus monolithic columns

SEC purification

TFF hollow fiber/flat sheet

Cryo-TEM

DLS

NTA

Job description

Pivotal Life Sciences in San Diego is seeking a Principal Scientist/Associate Director to lead downstream process development for our targeted lipid nanoparticle platform. You will purify, concentrate, and buffer-exchange LNPs using SEC and TFF, while preserving particle integrity and cargo activity.

The role involves formulation development, stability assessment, technology transfer to CDMOs, and active collaboration with cross‑functional teams. Title/salary commensurate with experience.