Associate Scientist II, Formulation and Process Development

Role Summary

The Associate Scientist II will join the tLNP drug product formulation and process development team to work on formulation and process development of lipid nanoparticle-based drug products to support emerging research pipelines.

This role is hands-on laboratory work reporting to the Principal Scientist, based in the San Diego office, and conducted in accordance with company SOPs.

Experience with lipid nanoparticle formulation and purification, or with biologics process development, is highly desired.

Responsibilities

• Prepare, formulate, and characterize nucleic-based complex lipid nanoparticle formulations.
• Design, execute, and analyze DOE-based formulation experiments to develop and optimize novel LNP formulations and novel process development.
• Develop novel formulation and conjugation process for lipid nanoparticles based nucleic acid formulations with targeting modalities, as well as scale-up process.
• Perform investigations of aberrant results, determination of root causes, and recommend action plan to ensure process robustness.
• Maintain proper documentation of all experimental procedures and results, including batch records, protocols, Standard Operating Procedures (SOPs) and other manufacturing related documentation.
• Prepare technical reports and presentations which summarize procedures, study results, and data interpretation as needed.
• Work with other formulations and/or colleagues in other departments as a team, delivering high quality results in an accurate and time-sensitive manner.

Qualifications

• Bachelor’s Degree, or equivalent education, with 3 or more years’ experience, or Master’s Degree or equivalent education (no additional experience).
• Understanding of lipid-based delivery systems and formulation science principles.
• Hands-on experience working with nucleic acid and/or lipid nanoparticle-based formulations, complex/nanoparticle formulations, other biological formulation, and working knowledge of tangential flow filtration or other purification processes.
• Ability to work in a well-lit heated and/or air-conditioned indoor office and occasional laboratory setting with adequate ventilation. Light physical activity performing non-strenuous daily activities of a productive/technical nature. May require long periods of standing/sitting.
• Comfortable working in a highly innovative, changing, fast-paced environment with multi-task skills is required.
• Ability to work under pressure and tight deadlines. Has the discipline to stay focused and complete specific tasks.
• Detail oriented with good organizational skills. A team player with excellent verbal and written communication skills.

Skills

• Understanding of lipid-based delivery systems and formulation science principles.
• Hands-on experience with nucleic acid and/or lipid nanoparticle-based formulations, complex/nanoparticle formulations, and purification processes (e.g., tangential flow filtration).
• DOE design and data analysis; technical reporting and presentation skills.
• Strong documentation, communication, and collaboration abilities.

Additional Requirements

• Physical and environmental: ability to work in a well-lit indoor office and occasional laboratory setting with adequate ventilation; light physical activity; long periods of standing or sitting may be required.