The job responsibility within the Biological Technologies group in Analytical Development and Quality Control, is to develop, validate, and troubleshoot bioanalytical/biological methods to characterize clinical products.
- The successful candidate will be expected to perform the development of bioanalytical binding assay such as Surface Plasmon Resonance (SPR-Biacore) to assess the antibody-target interaction and Fc effector functions of therapeutic antibodies.
- Additional responsibilities may include using automation system, writing data analysis template for new assays, summarizing/presenting data, and supporting collaborations with other groups/sites.
- In addition, he/she will perform sample testing in support of process development, characterization, formulation screens, and stability according to established test procedures and in compliance with cGMP’s.
- Expectations may also include writing S.O.P.’s, test procedures, protocols, and reports, equipment qualification and maintenance, supporting IND/BLA filing and participating in inspection by regulatory agencies.
- PhD in the field of Biological Sciences with a strong critical thinking ability. Post graduate experience is not required but a plus.
- Background knowledge and a strong technical experience in molecular interaction work (e.g., binding affinity measurement using surface plasmon resonance (SPR-Biacore)) are essential.
- Proficiency in the development and performance of cell-based assays would be a plus.
- cGMP familiarity/knowledge is a plus but not required.
- Must have demonstrated ability to work independently as well as with a team, handle multiple projects, demonstrate initiative, strong attention to detail, with effective verbal and written communication skills are a must.
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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