QC Scientist

3 weeks ago

San Diego CA, United States Cedent Consulting Inc. Full time

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.

To be considered for an interview, please make sure your application is full in line with the job specs as found below.

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 method qualification/ validation and transfer to QC team.

Serve as subject matter expert in cutting-edge technologies and platforms used for bioanalysis and nanoparticle characterization.

Proactively identify assay issues and assay needs to support the company pipeline projects.

Author and review corresponding CMC sections in regulatory filings and responses.

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.) ELISA, Western Blot, PCR-based methods and other bioassay experiences highly desirable.

Experience in biologics regulatory submissions (IND, BLA) desirable.

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