Scientist

Proclinical is seeking a Scientist with a leading biopharmaceutical company located in Irvine, CA.

Job Responsibility:

• Independently plan experimental work and executes protocols in support of biologics process development, formulation development, and stability studies.
• Independently generates, compiles, and evaluates data for technical reports to support regulatory filings for new and currently marketed biological products.
• Responsible for writing sections or subsections of technical reports, method or operational SOPs.
• Independently carries out multiple analytical methods to support biologics projects depending on departmental needs.
• Maintains a productive and collaborative laboratory environment consistent with regulatory and company expectations.
• Responsible for the analysis and characterization of neurotoxin and biologics entities to support the development, qualification, transfer and validation of analytical methods with experience required in the following:
  • Cell based bioassay, immunoassay, potency assay

Skills and Requirements:

• BS in Chemistry or Biology with two to several years of experience or a MS with 0-2 years of experience
• Extensive experience is required with the application of cell culture, molecular biology, immunoassay, and bioassay techniques for the characterization of proteins and their degradation and modification products.
• Experience with separation, mass spectrometric, and biophysical techniques is a plus.
• Understanding in CMC development strategy of biologics drugs is expected.
• Separation techniques including HPLC (RP, SEC, HIC, IEX), gel and capillary electrophoresis (SDS-PAGE, native-PAGE, CE, cIEF)
• Characterization techniques such as mass spectrometry and biophysical-based characterization methods (UV, fluorescence, light scattering, subvisible particle analysis, CD, AUC, DSC, ITC)
• Knowledge in cGMP regulations and hands-on cGMP experience are also desired.

If you are having difficulty in applying or if you have any questions, please contact Kate Heffernan at (+1) 610-624-3327 or K.Heffernan@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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