A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.That’s what makes us Roche.The Opportunity:As the Purification Engineer within the MSAT Purification group, with responsibility for specifying manufacturing process requirements, monitoring and analysis of manufacturing process data, execution of full-scale process validation and technical oversight of scale-down (laboratory) experiments, and analyzing process and facility capabilities to identify improvement opportunities.Provide purification technical leadership to support commercial drug substance production at Vacaville, including specification of process requirements, monitoring, analysis, troubleshooting, and maintenance of the validated state of the manufacturing process.Provide a science-based approach for the resolution of deviations, investigations, and process issues through analysis of historical data and scale-down studies.Authoring and/or review technical documents related to technology transfer, process monitoring, at-scale or scale-down studies, annual product reviews, and non-conformance (deviations/investigations) to support process transfer and ongoing manufacturing.Contribute to the design, formulation, review, and implementation of purification manufacturing formulae, SOPs, and associated process documents.Lead or participate in process validation and technology transfer activities, as well as health authority prior approval inspection for commercial license and product launch.Who you are:BS or higher degree in Chemical or Biochemical Engineering.10 + years for B.S (or 5+ years for MS or 2+ years for PhD) work experience in cGMP biopharmaceutical production settingExperience in large-scale biopharmaceutical manufacturing process, as applied to purification processes (harvest, chromatography, filtration and ultrafiltration diafiltration operations) – including scale-up/scale-down, principles of biochemical engineering, and process data analysisFull understanding of cGMP requirementsProficiency in statistical and multivariate data analysis techniquesRelocation is NOT available.The expected salary range for this position based on the primary location of California is $110,000 min and $195,000 max of hiring range. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
