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Description

Summary
Corporate Technology and Methods Management represents a recently established function within the Commercial Quality Support Group. Technology and Method Management is responsible for innovation and life-cycle management of commercial methods in Genentech's Corporate Quality Product organization. In line with the mission of the department, the Bioassay Function serves as a scientific and technical Center of Excellence for biological assays within commercial quality. We are looking for an experienced biological scientist 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 would be an asset. Prior experience in assay validation/ qualification and transfer are highly desirable. Exceptional assay trouble-shooting skills are essential. GMP experience is a plus. Familiarity with common applications analyzing the dose-response relationship will be very helpful (SoftMaxPro, XLFit, PLA etc). Must be highly motivated and comfortable working independently in a fast-paced environment. Candidates must be hands-on and able to design and carry out well-designed experiments with excellent quality.

Education and Experience
The successful candidate must have a Ph.D. in Biological Sciences (Immunology, Cell Biology or related field) and significant knowledge of the bioassay field. Prior experience in performing cell-based and biochemical/immunological assays in the context of potency determination is required. Successful candidates will be expected to be hands-on and to generate, analyze, and present data, write protocols and reports, justify changes to existing documents, support regulatory filings and responses. Effective supervision of technical associates is expected. Excellent skills in teamwork and collaboration are a must.

Strong science, creativity, flexibility, and a mindset of continuous learning are a must for the candidate to be successful in this environment. Work will cover a broad range of therapeutic proteins using a variety of assay formats to measure biological activity. The candidate has to work independently as well as with teams, handle multiple projects, demonstrated initiative, strong attention to detail and effective verbal and written communication skills.
 

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Description

Summary
Corporate Technology and Methods Management represents a recently established function within the Commercial Quality Support Group. Technology and Method Management is responsible for innovation and life-cycle management of commercial methods in Genentech's Corporate Quality Product organization. In line with the mission of the department, the Bioassay Function serves as a scientific and technical Center of Excellence for biological assays within commercial quality. We are looking for an experienced biological scientist 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 would be an asset. Prior experience in assay validation/ qualification and transfer are highly desirable. Exceptional assay trouble-shooting skills are essential. GMP experience is a plus. Familiarity with common applications analyzing the dose-response relationship will be very helpful (SoftMaxPro, XLFit, PLA etc). Must be highly motivated and comfortable working independently in a fast-paced environment. Candidates must be hands-on and able to design and carry out well-designed experiments with excellent quality.

Education and Experience
The successful candidate must have a Ph.D. in Biological Sciences (Immunology, Cell Biology or related field) and significant knowledge of the bioassay field. Prior experience in performing cell-based and biochemical/immunological assays in the context of potency determination is required. Successful candidates will be expected to be hands-on and to generate, analyze, and present data, write protocols and reports, justify changes to existing documents, support regulatory filings and responses. Effective supervision of technical associates is expected. Excellent skills in teamwork and collaboration are a must.

Strong science, creativity, flexibility, and a mindset of continuous learning are a must for the candidate to be successful in this environment. Work will cover a broad range of therapeutic proteins using a variety of assay formats to measure biological activity. The candidate has to work independently as well as with teams, handle multiple projects, demonstrated initiative, strong attention to detail and effective verbal and written communication skills.