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.
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 next step is yours. To apply today, click on the "Apply online" button below.
- 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
experience in performing quantitative cell-based and
biochemical/immunological assays in the context of relative potency
determination is highly desirable
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
- 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
Roche - 11 months ago
Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...