Date : Aug 14, 2013
Job Function : Quality & Compliance
Company/Division : Pharmaceuticals
Schedule : Full-time
Job type : Regular Employee
Job Level : Experienced
Who We Are
At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. The Position
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 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
Genentech is an Equal Opportunity Employer.
Genentech, Inc. (Genentech) is a biotechnology company that discovers, develops, manufactures and commercializes pharmaceutical products to...