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QC Assay Development Specialist - Sunnyvale, CA - United States  

Company managed [?] Still accepting applications

Posted on : 16 April 2017

Project Description

Are you a quality control expert who would thrive in a GMP environment? Do you desire a quality role where you can utilize your keen assay development expertise? If yes, then come and join us as…

Your tasks

As a member of the Miltenyi Biotec Quality team, you will have the opportunity to lead and execute the daily Quality Control activities associated with biological and molecular assay development processes, transfers, and qualifications as well as the QC release testing and environmental monitoring to support the GMP manufacturing of T – Cells and CAR – T Cells. The unique duties of this position will consist of leading the QC assay development processes including the design, execution, and analysis of development studies and reports, the execution of QC release, in-process and stability testing of raw materials, intermediates and cell based final products. Furthermore, you will be responsible for writing, reviewing, and revising test methods, assay qualification protocols, SOPs, and other controlled documents. Overall, your keen ability to lead and execute all QC assay development processes will champion the continued development of Miltenyi Biotec products and growing success.

Your profile

  • You hold a M.S. degree in biological science or related discipline, with 2 to 5 years of hands- on research and/or QC assay development experience preferably in a cellular manufacturing environment
  • You have GMP compliance and Quality Control knowledge; intimate familiarity with industry guidelines, such as ICH, cGMP, and GLP as it applies to cell therapy products; thorough understanding of analytical method lifecycle, including assay development, qualification, transfer, and maintenance
  • You possess a broad familiarity with techniques in molecular biology, cell biology, and protein chemistry
  • You are also an effective and timely cross-functional communicator
Miltenyi Biotec is a company that is transforming and progressing. Our culture is one of bold scientific innovation. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

At Miltenyi Biotec Inc., we have developed state of the art manufacturing processes for innovative cellular therapies. We are scientists, engineers, physicians, support specialists, and more – all dedicated to improving scientific understanding and impacting human lives. At our Sunnyvale facility we strive to find solutions to both the technical and conceptual barriers to enable development of cell and gene therapy approaches for the treatment of human disease.

Miltenyi Biotec, Inc. is an EO Employer – M/F/Veteran/Disability