THE OPPORTUNITY
In this role, you will support scale-up, manufacturing, and characterization of lipid nanoparticle-based nucleic acid formulations to support our emerging research pipeline. Our ideal candidate will bring a willingness to learn and contribute to our formulation production and purification processes.
WHAT YOU WILL CONTRIBUTE
- Develop and nucleic based formulations including complex nanoparticle formulations.
- 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.
- Perform formulation stability studies, contact material compatibility, and stability in the study, in-use compatibility study, and accelerated stability studies.
- 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 in a time sensitive manner
- Maintain accurate and timely records
- Perform other activities as needed
WHAT WE SEEK- 1-2 years of related experience in life science, pharmaceutical company or academic lab setting.
- Experience with nucleic acid-based formulations, complex/nanoparticle formulations, and knowledge of tangential flow filtration.
- Hands-on expertise working with liquid, frozen, and/or lyophilized dosage forms.
- Hands-on experience or working knowledge of one or more analytical instrumentation, such as HPLC, LC-MS, Akta, Dynamic Light Scattering, Plate reader, etc.
- 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 is required.
- Ability to work overtime, as required, including weekends.
- Willingness and motivation to learn new techniques and protocols
EDUCATION - Bachelor's degree in chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, Bioengineering or other related science field;
