Analytical Scientist/Senior Scientist Client is seeking an Analytical Scientist/Senior Scientist 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. 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.
