As a member of the Late-Stage LNP Process Development team, the candidate will be joining a team conducting laboratory studies to support the process development, process scale-up, and process characterization of LNP clinical stage drug products. The successful candidate will have experience with LNP process development (having additional experience in tech transfer and GMP manufacturing is a plus but not required), and a desire to contribute to a team focused on establishing science-based manufacturing solutions for complex nucleic acid-based drug products. In this highly collaborative and cross-functional role, the candidate will support the refinement of process control and improve process understanding for multiple programs at various stages of clinical development.
- Support routine process development and process characterization activities centered around the LNP drug product manufacturing process. Batch ranges vary from 10 mg to 1 gram.
- Execute routine analytics including dynamic light scattering (DLS), UV-quantification via Ribogreen®, pH, and osmolality for in-process monitoring.
- Perform experiments under limited to no supervision under subject matter expert guidance.
- Organize and analyze data, interpret results, and present findings within the process development team and cross-functionally.
- Author technical documentation (SOPs, reports, protocols) as required.
- Document experiments and protocols using electronic lab notebooks (e.g., Benchling).
- Maintain laboratory equipment, order critical reagents, and support operational excellence activities.