Responsibilities
- 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.
- 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.
Requirements
- Experience with LNP process development.
Nice to Have
- Additional experience in tech transfer and GMP manufacturing is a plus but not required.
Team
Structure: Late-Stage LNP Process Development team
Additional Information
- Batch ranges vary from 10 mg to 1 gram.
