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Genentech Process Engineer/Manufacturing in South San Francisco, California,
Process Engineer/Manufacturing
South San Francisco, California
Job ID: 202011-129176
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The Position
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 as an Engineer or Manufacturing Technical Specialist (MTS). The job family and level of the position will depend 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); candidates with more extensive experience may be considered for a senior level.
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
Who We Are
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
The next step is yours. To apply today, click on the "Apply for this job" button.
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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