Chemical Engineer II Thousand Oaks, California
Yoh has a long-term contract opportunity for a Chemical Engineer II to join our client, a world leader in the pharmaceutical industry, located in Thousand Oaks, CA.
Job Responsibilities:
- Perform pilot-scale process development studies, trouble-shoot issues, interpret results and apply findings to develop the anticipated commercial process for a liquid commercial drug product prior to manufacturing of Phase 3 clinical supplies.
- Perform visual inspection of protein drug products to identify onset of sub-visible particle formation as well as units with foreign particles.
- Evaluate capabilities of existing and new automated visual inspection equipment to inspect high viscosity drug product formulations in support of commercial manufacturing.
- Design and execute studies to characterize the commercial process and develop a detailed understanding of operating and performance parameters in support of successful validation runs.
- Execute studies to address non-conformances and investigations during routine clinical and commercial manufacturing.
- Author development and characterization technical study reports as well as technology transfer documentation in support of regulatory filings.
- Author and witness experiments in Electronic Lab Notebook.
- Responsible for training and maintenance of laboratory equipment.
Job Qualifications:
- BS/MS in Chemical Engineering, Biochemical Engineering, Biomedical Engineering or Pharmaceutical Sciences with 3+ years experience in biotechnology/pharmaceutical industry.
- Experienced with the following:
- Process development for Phase I - III biologic drug products,
- Manufacturing support including addressing non-conformance and investigations
- Analytical methods including micro-flow imaging
- Protein concentration
- Rheometers
- Statistical analysis
- Design of experiments
- Writing/reviewing of technical and manufacturing documents
- Visual inspection of protein drug products
- Documentation in Electronic lab notebooks.
Discover all that's possible with Yoh. Apply now.
Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading staffing solutions.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
Job Responsibilities:
- Perform pilot-scale process development studies, trouble-shoot issues, interpret results and apply findings to develop the anticipated commercial process for a liquid commercial drug product prior to manufacturing of Phase 3 clinical supplies.
- Perform visual inspection of protein drug products to identify onset of sub-visible particle formation as well as units with foreign particles.
- Evaluate capabilities of existing and new automated visual inspection equipment to inspect high viscosity drug product formulations in support of commercial manufacturing.
- Design and execute studies to characterize the commercial process and develop a detailed understanding of operating and performance parameters in support of successful validation runs.
- Execute studies to address non-conformances and investigations during routine clinical and commercial manufacturing.
- Author development and characterization technical study reports as well as technology transfer documentation in support of regulatory filings.
- Author and witness experiments in Electronic Lab Notebook.
- Responsible for training and maintenance of laboratory equipment.
Job Qualifications:
- BS/MS in Chemical Engineering, Biochemical Engineering, Biomedical Engineering or Pharmaceutical Sciences with 3+ years experience in biotechnology/pharmaceutical industry.
- Experienced with the following:
- Process development for Phase I - III biologic drug products,
- Manufacturing support including addressing non-conformance and investigations
- Analytical methods including micro-flow imaging
- Protein concentration
- Rheometers
- Statistical analysis
- Design of experiments
- Writing/reviewing of technical and manufacturing documents
- Visual inspection of protein drug products
- Documentation in Electronic lab notebooks.
Discover all that's possible with Yoh. Apply now.
Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading staffing solutions.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
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