Roche - South San Francisco, CA

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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 a Scientist to take on an important role and to play an integral part in the function.
Who you are

In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because we know that employees are critical to our success in bringing novel medicines to patients, we are dedicated to remaining a great place to work and to providing employees with programs, services and benefits that allow them to bring the best to the business and to their personal lives. Requirements :

Candidates must have experience in the development of cell-based potency assays and immunoassays. Understanding of mechanism-of-action of antibody-based protein therapeutics is essential. Broad experience with a variety of biological in-vitro systems is required. Prior experience in assay validation/ qualification and technology transfer are 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). Must be highly motivated and comfortable working independently in a fast-paced environment.

Education and Experience :
  • The successful candidate must have a Ph.D. in Biological Sciences (Immunology, Cell Biology or related field) with at least 3 years of industry experience and knowledge of the biological assay field

  • Prior experience in performing quantitative cell-based and biochemical/immunological assays in the context of relative potency determination is highly desirable

  • 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

  • Strong knowledge of cGMP and regulatory requirements is highly desirable

  • Experience with full ICH validation of methods intended for commercial use is highly desired

  • Strong planning and project management skills are necessary

  • Excellent skills in teamwork and collaboration with international and external partner organizations are required

  • Strong communication (written and verbal) and presentation skills are a must

The next step is yours. To apply today, click on the "Apply online" button below.

Roche - 11 months ago - save job - block
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Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...