Dept: Biological Assays, Method Management and Technology, PTQBP

Job Category: Quality
Location: SSF

Department: MMTech (Method Management and Technology)
Description: Senior Scientist Bioassay

Summary

The Biological Assay Function within Genentech’s Global Quality Organization is responsible for life-cycle management and innovation of post-BLA biological potency methods and specifications. We serve as the scientific and technical Center of Excellence for biological assays and analytical ELISAs within Commercial Quality for the Roche/Genentech Global Quality Network. We are looking for an experienced Senior Scientist to take on a leadership role and to play an integral part in the function.

 
Requirements

Candidates must have in-depth experience in the development of cell-based potency assays and immunoassays in an industrial setting. Understanding of mechanism-of-action of antibody-based protein therapeutics is essential. Broad experience with a variety of biological in-vitro systems is required. Familiarity with antibody effector function determination and enzymatic assays would be an asset. Prior experience in assay validation/ qualification and technology transfer are highly desirable, as is GMP experience and a strong sense for compliance. Familiarity with common applications analyzing the dose-response relationship will be very helpful (SoftMaxPro, XLFit, PLA etc). Working knowledge of statistical approaches will be helpful. Must be highly motivated and comfortable working independently in a fast-paced environment. Experience with regulatory submissions (IND/BLA) and Health Authority interactions will be advantageous. Management experience of direct reports is expected.

The successful candidate must have a Ph.D. in Biological Sciences (Immunology, Cell Biology or related field) and significant knowledge of the biological assay field for CMC and Quality applications. Prior experience in performing quantitative cell-based and biochemical/immunological assays in the context of relative potency determination is required. Successful candidates will be expected to be flexible, strategic as well as hands-on, able to design well-defined experiments as well as development and validation strategies,  analyze and present data, write protocols and reports, justify changes to existing methodology, and to support global regulatory filings and responses with scientific and technical expertise. Excellent skills in teamwork and collaboration with international partner organizations are required.

 

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