South San Francisco
California, United States of America
Genentech’s South San Francisco manufacturing facility has an opportunity available in the Process Engineering group supporting cGMP manufacturing of both clinical and commercial products. The group is responsible for authoring and executing process validation studies, monitoring and improving Drug Substance and Drug Product operations from seed train through aseptic filling, and providing scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role.
Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
Provide manufacturing floor technical support for validation study execution
Monitor and analyze manufacturing data as necessary to provide support for process discrepancies, investigations, validation studies, process transfers, or equipment troubleshooting
Analyze data and execute experiments aimed at improving process robustness/productivity or meeting the changing needs of the manufacturing environment
Implement engineering projects of various magnitude in order to increase levels of safety and/or compliance, improve process and equipment robustness, or increase capacity/productivity/efficiency.
Support process validation impact and root cause assessments for process discrepancies and Quality investigations
Support of regulatory inspections and filings
Provide training and technical mentorship for manufacturing operators
Lead cross-functional technical teams on large scale improvement and compliance related initiatives
Bachelor’s degree in Engineering, Science, or related discipline
5+ years of relevant experience in industry or academia (including advanced studies) post Bachelor’s degree
Experience working in a cGMP environment
Experience with cell culture and/or purification process science/development strongly preferred Knowledge of safety principles, quality systems, and cGMP
Relevant work experience in a lab, pilot plant, manufacturing, or manufacturing support setting
Able to work independently and as part of a team
Strong oral and written communication skills
Excellent organization skills
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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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
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