Job Abstract

This role is an integral part of our Manufacturing Sciences and Technology (MSAT) team, dedicated to ensuring the successful production of high-quality drug substances for commercial use.  As a member of this team, you will have the opportunity to work closely with multi-functional groups such as Process Development, Analytical Development, Manufacturing, and Quality to provide technical leadership in purification processes. Your responsibilities will include specifying manufacturing process requirements, conducting process validation, analyzing data, solving process issues, and contributing to the design and implementation of purification manufacturing formulae and associated documents. Your expertise and leadership will play an important role in ensuring the successful technology transfer, process validation, and health authority inspections for commercial license and product launch.

The Opportunity:

As a Senior Engineer within the MSAT Purification group, you will play a vital role in providing technical leadership for the successful production of commercial drug substances, including process specification, monitoring and analysis of manufacturing process data, execution of full-scale process validation and technical guidance of scale-down (laboratory) experiments, and analyzing process and facility capabilities to identify improvement opportunities.  Additionally, you will:

• 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.

• Author 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:

• You possess a Bachelor’s degree in Engineering or related discipline and 10 years of related MSAT experience OR Master’s degree and 5 years of related MSAT experience OR PhD and 2 years of related MSAT experience

• Demonstrated proficiency in cGMP biopharmaceutical production setting

• Demonstrated experience 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 analysis

• Demonstrated proficiency in statistical and multivariate data analysis techniques

Relocation benefits are not available for this posting.  

This is an onsite position. 

The expected salary range for this position based on the primary location of Vacaville, California is $105,600 - $196,200.  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.

Benefits

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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.