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QC Scientist, Pharmaron Biologics

Pharmaron-China
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Responsible for QC sample testing and release as well as problem solving, as an expert in QC analysis methods, lead the transfer, validation and optimization of analysis methods.
Responsibilities
  1. As an expert in QC methods, you are responsible for researching and understanding the principles of basic QC testing methods, instrument principles and being able to promptly identify and solve QC method problems.
  2. Implement and follow QC laboratory GMP standard operating procedures to complete the testing tasks of raw materials and products, write and upgrade QC testing methods, record testing data on time, complete corresponding reports, and ensure the truth and integrity of data.
  3. To participate in the establishment of quality specifications for raw materials and products, and provide scientific justification for the establishment of quality specifications.
  4. Participate in OOS/OOT and deviation investigation in the laboratory
  5. Support internal/external and regulatory agency audits.
  6. Lead method transfer and validation activities.
  7. Support QC project management.
  8. Interaction and collaboration with analytical development department or third party services.
Qualifications
  1. PhD in basic science or engineering, with a certain level of knowledge in the field of biopharmaceuticals is preferred
  2. Have a certain depth of hands-on ability and problem solving experience in physicochemical or biochemical analysis methods and in vitro cell detection.
  3. Proficient in common protein analysis methods, biological activity detection methods, as well as their methodology and applications.
  4. Having experience in various (or partial) analytical techniques such as HPLC, CE, cIEF, ELISA, LC-MS, ELISA, biossay, osmolarity, endotoxin, moisture content (Karl Fischer), TOC, particle analysis of injected drugs, and process impurity analysis (rDNA, rHCP, rProA).
  5. Understand the production process of biopharmaceuticals, especially monoclonal antibodies.
  6. Having good teamwork, communication, and organizational skills.
  7. Proficient in both Chinese and English.