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 monitoring, troubleshooting, and improving upstream and downstream unit operations from seed train through bulk formulation, 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.
Responsibilities of this position include:
Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
Provide manufacturing floor technical support
Monitor and analyze manufacturing data as necessary to provide support for process discrepancies, investigations, validation protocols, 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 product impact and root cause assessments for process discrepancies and Quality investigations
Support of regulatory inspections and filings
Create / revise standard operating procedures and manufacturing tickets
Provide training and technical mentorship for manufacturing operators
Lead cross-functional technical teams on large scale improvement and compliance related initiatives
We are seeking applicants who possess the following minimum qualifications. The position can be filled at a more senior level depending on the qualifications of the selected candidate.
Bachelor’s degree in Engineering, Science, or related discipline
2+ 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
Knowledge of large scale biopharmaceutical manufacturing processes and equipment
Relevant work experience in a lab, pilot plant, manufacturing, or manufacturing support setting
Highly motivated and proactive with a track record of taking initiative to achieve business results
Demonstrated strong problem solving capabilities
Able to work independently and as part of a team
Strong oral and written communication skills
Excellent organization skills
As with any position in a manufacturing environment, the job requires an ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule. Requires the ability to routinely access and work for extended periods of time in a cGMP facility, including adherence to all gowning (no makeup or jewelry can be worn) and safety procedures.
This position is not eligible for relocation. Only local candidates will be considered.
Who We Are
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 .