Senior Scientist – Therapeutic Antibody Bioassay Development

职位描述：

• Innovation skills and leadership in development of novel cell-based assays and immunoassays in support of therapeutic antibody or other biotech product portfolio.
• To ensure compliance to regulatory requirement, including instrument maintenance, personnel training, document drafting, review and archiving.
• Gradually manage a team of junior scientists to conduct bioassay development, qualification / validation and sample testing for lot release, in-process, Stability and R&D samples under a GMP environment until established as part of a clinical control system.
• Transfer, training and trouble-shooting of Cell-based Assays to collaborating QC labs
• To represented the department in CMC team for selected projects.

职位要求：

• PhD in Biochemistry / Biotechnology, Cell Biology, Immunology or related field.
• 0-3 years of industrial experience in functional biochemical, cell-based assay, and potency assay.
• Strong working knowledge of regulatory requirement. Experience with the use of electronic lab notebooks.
• Strong technical innovation and trouble-shooting skills in bioassay or immunoassay development, validation, and performance.
• In-depth knowledge with ELISA, flow cytometry, cell signal transduction, immune regulation and mammalian cell culture.
• Excellent spoken and written communication skills in English is a must.
• Experience with regulatory filings preferred.

WuXi AppTec

公司介绍

Established in December 2000, WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with operations in China and the United States. As an innovation-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of services throughout the drug R&D process. Our services are designed to help our worldwide customers shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions.
WuXi AppTec has successfully established a fully integrated services and technology platform during the past decade. The company built its initial capabilities around discovery chemistry and has further enhanced the integrated services with analytical services, bio-analytical services, process research, process development services, API manufacturing services, DMPK/ADME, discovery biology, pharmacology, formulation, toxicology, genomic services, biologics manufacturing services, antibody and biological research reagent manufacturing and sales, and most recently clinical research and regulatory services.
WuXi AppTec has developed from four founders and a single laboratory in December 2000 to 10,000 employees and 5 million square feet of laboratory and manufacturing space, including facilities under construction. The company is actively improving its capabilities and capacity through new expansions in its global business. Capitalizing on the great advantage of conducting R&D services both in China and in the U.S., WuXi AppTec is building an alternative R&D engine to serve the global life-science industry.

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