Scientist/Sr. Scientist, Analytical (San Diego, CA)

Client is seeking an Analytical Scientist/Senior Scientist (level dependent on experience) to join the Analytical Development Team. The Scientist/Senior Scientist will be responsible for developing, performing, and qualifying analytical methods in support of cellular nanoparticle platform based new product development for DS/DP and in-process samples. This is a multi-functional role in an agile and fast-paced environment, working on a novel and differentiated cellular nanoparticle technology.

Essential Duties and Responsibilities

• 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.

Qualifications

• 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.