QC Assay Development Associate - Sunnyvale, CA | Biospace
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QC Assay Development Associate

Miltenyi Biotec, Inc.

Sunnyvale, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Masters Degree
Areas of Expertise Desired:
Assay Development, Cell Biology, Molecular Biology, QC, Quality Control,

Job Description

Do you desire a quality role where you can utilize your assay development expertise? If yes, then come and join us as…

QC Assay Development Associate
Sunnyvale, CA
Your Tasks:
As a member of the Miltenyi Biotec Quality team, you will have the opportunity to participate in the daily Quality Control activities associated with biological and molecular assay development processes, transfers, and qualifications. Additionally you will be involved with 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 supporting the QC assay development process 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 technical nature 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 1-3 years of hands on research and/or QC assay development experience, preferably in a cellular manufacturing environment.
•   You have GMP compliance and Quality Control experience including intimate familiarity with industry guidelines such as ICH, cGMP, and GLP as it applies to cellular therapy products.
•   You display a 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; experience with real-time and/or digital PCR is highly desirable.
•   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

To apply, go to: https://recruiting.ultipro.com/MIL1021/JobBoard/32d3b48e-d591-654f-e0c4-d4072bba11d0/OpportunityDetail?opportunityId=f576fff1-1740-4981-a9ae-fc57dd244b4f