Scientist/Sr. Scientist, Analytical
- Independently design, develop and troubleshoot analytical assays, including but not limited to nanoparticle analysis, lipid analysis, potency assays, ELISA, Western Blot, PCR-based assays, flow cytometry.
- Lead analytical method development and optimization for biological substances and nanoparticles.
- Lead method qualification/ validation and transfer to QC team.
- Proactively drive collaboration with internal and external partners to design and execute analytical studies in support of process development, stability, pre-clinical, and clinical programs.
- Serve as subject matter expert in cutting-edge technologies and platforms used for bioanalysis and nanoparticle characterization.
- Perform analytical testing to support DS/DP characterization and process development.
- Proactively identify assay issues and assay needs to support the company pipeline projects.
- Author and review corresponding CMC sections in regulatory filings and responses.
- Author and review assay SOPs, analytical study/qualification protocols and reports.
- Ph.D. in Biochemistry, Chemistry, Chemical Engineering or related discipline with 2+ years of experience, or M.S. with 5+ years of experience in Biotechnology or Pharmaceutical Industry.
- Experience in chromatography and other biophysical methods (HPLC/UPLC/CE, DLS, Nanosight, Flow Cytometry, etc.) highly desirable.
- Hands-on experience in cell-based analytical methods and biologic product characterizations highly desirable.
- ELISA, Western Blot, PCR-based methods and other bioassay experiences highly desirable.
- Experience with TFF or microfluidizer is desirable.
- In-depth knowledge in lipid nanoparticle (LNP) for drug delivery highly desirable.
- Experience in biologics regulatory submissions (IND, BLA) desirable.
- Excellent problem-solving skills and verbal and written communication skills.
- Self-motivated and able to thrive in a dynamic environment.
- Open-mindedness to learn and share professional knowledge and experience.
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