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RESEARCH ASSOCIATE - BAS
Job Field: Government Jobs
Location: United States, CA
Salary: $Not stated
Location: United States, CA
Salary: $Not stated
JOB SUMMARY:
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<tr><td valign="top" width="450"><b>Job ID:00408392Job104of371Research Associate - BASSouth San Francisco, CaliforniaJob factsJob functionDevelopmentLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelExperiencedServiceDirect linkApply OnlinePrintWho We AreAt 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 PositionBioAnalytical Sciences (BAS) develops, implements andprovides strategic direction for state of the art bioanalytical methods andautomation systems. BAS data andexpertise enable the characterization of the pharmacokinetic, immunogenic andin vitro biological activities of Genentech biotherapeutics during drugdevelopment and throughout the product life cycle.The Research Associate (RA) will support Genentechdevelopment projects by coordinating PK/PD/Immunogenicity assay maintenance andstudy coordination activities for multiple projects. The RA will maintainGLP/GCP compliance in supporting clinical and nonclinical studies, and willapply thorough and accurate documentation skills. The RA will also collaborate and interact cross-functionallywith assay developers, sample testing group, core reagent facility, compliancegroups and customers, to deliver the highest quality data possible. * Assist with assay implementation (SOP, WATSON LIMS master assay)* Prepare and execute the assay maintenance plan* Prepare ISR plan, coordinate ISR testing, and summarize results in a report* Revise assay SOP/worksheets/validation reports* Use LIMS to track sample chain of custody, track and montior assay performance and review study results.* Closely monitor assay performance to ensure optimal assay quality and the validated state of the assays* Inform the reagent group and assay developers of assay performance on an on-going basis* Qualify and incorporate new reagents (experimental design, data analysis, report and worksheets)* Participate in the assay team for each development project* Plan and monitor reagent inventory* Coordinate study result timelines* For GLP studies, prepare documentation for audit and archive GLP documents* Present scientific and technical data at cross-functional team meetingsWho You AreBachelor
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<tr><td valign="top" width="450"><b>Job ID:00408392Job104of371Research Associate - BASSouth San Francisco, CaliforniaJob factsJob functionDevelopmentLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelExperiencedServiceDirect linkApply OnlinePrintWho We AreAt 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 PositionBioAnalytical Sciences (BAS) develops, implements andprovides strategic direction for state of the art bioanalytical methods andautomation systems. BAS data andexpertise enable the characterization of the pharmacokinetic, immunogenic andin vitro biological activities of Genentech biotherapeutics during drugdevelopment and throughout the product life cycle.The Research Associate (RA) will support Genentechdevelopment projects by coordinating PK/PD/Immunogenicity assay maintenance andstudy coordination activities for multiple projects. The RA will maintainGLP/GCP compliance in supporting clinical and nonclinical studies, and willapply thorough and accurate documentation skills. The RA will also collaborate and interact cross-functionallywith assay developers, sample testing group, core reagent facility, compliancegroups and customers, to deliver the highest quality data possible. * Assist with assay implementation (SOP, WATSON LIMS master assay)* Prepare and execute the assay maintenance plan* Prepare ISR plan, coordinate ISR testing, and summarize results in a report* Revise assay SOP/worksheets/validation reports* Use LIMS to track sample chain of custody, track and montior assay performance and review study results.* Closely monitor assay performance to ensure optimal assay quality and the validated state of the assays* Inform the reagent group and assay developers of assay performance on an on-going basis* Qualify and incorporate new reagents (experimental design, data analysis, report and worksheets)* Participate in the assay team for each development project* Plan and monitor reagent inventory* Coordinate study result timelines* For GLP studies, prepare documentation for audit and archive GLP documents* Present scientific and technical data at cross-functional team meetingsWho You AreBachelor
KEY REQUIREMENTS:
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