Senior Research Associate, Formulation Development
Founded in 2013 and based in San Diego, Arcturus Therapeutics Ltd. is a publicly traded RNA medicines company. Arcturus’s commitment to the development of novel RNA therapeutics has led to partnerships with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, Synthetic Genomics Inc., and Cystic Fibrosis Foundation Therapeutics Inc..
Our corporate culture is diverse, open and creative. We value collaboration and teamwork. We are looking for team members to grow with us and with a strong dedication to the highest levels of scientific excellence.
The Senior Research Associate, Formulation/Process Development will focus on supporting design, development, scale-up, manufacturing, and characterization of lipid nanoparticle based nucleic acid formulations to support our emerging research pipeline. Our ideal candidate will bring experience with nanoparticle production and purification processes including tangential flow filtration (TFF – UF/DF).
- Design and develop nucleic based formulations including complex nanoparticle formulations;
- Process development, scale-up and technology transfer of multiple formulations, including supporting activities at CMO(s);
- Perform formulation stability studies including pilot stability studies with proposed drug product configuration, contact material compatibility and stability study, in-use compatibility study, and accelerated stability studies;
- Prepare and characterize dose formulations for various in vitro and in vivo studies;
- Perform process-related investigations, identify root causes of process/manufacturing discrepancies, evaluate systems for trends and adverse findings, and implement appropriate steps 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;
- Deliver high quality results in an accurate and a time sensitive manner;
- Perform other activities as needed.
- Bachelor or Master’s in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, bioengineering or other related science field;
- 5-8 years related experience in a life science or pharmaceutical company;
- Experience with nucleic acid based formulations, complex/nanoparticle formulations, nucleic acid based formulation and working knowledge of tangential flow filtration;
- Hands on expertise working with liquid, frozen, and/or lyophilized dosage forms;
- Familiarity with stages of drug product development and cGMP concept, knowledge of analytical methods for testing lipid nanoparticles and understanding of the in-vitro and in-vivo experiments used for screening of nanoparticle formulation highly preferred;
- Comfortable working in a highly innovative, changing, fast-paced environment required;
- Excellent verbal and written communication skills required.
Arcturus is committed to equal opportunity and complies with all applicable national, state and local laws governing nondiscrimination in employment.
For more information about our company, visit www.ArcturusRx.com.