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Quality Control Scientist IV
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- is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities.
- Quality Control Scientist IV , demonstrates full understanding of scientific and technical aspects of biological Drug Product/ Drug Substance (DP/DS), as well as technology transfer, assay qualifications and validations activities.
- Work with Analytical Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
- Candidate must possess knowledge and experience in analytical and QC operations of pharmaceutical industry, understand current regulations and industry trends of biologics product development, characterization and manufacturing testing requirement including cGMP, FDA, ICH, EMA and other global compendia regulations and guidance.
- Hands-on experience in modern analytical instruments, such as HPLC, UPLC, CE, iCE, ELISA, qPCR, Western Blotting, LC-MS/MS and Bioassays.
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