Manufacturing Engineer
3 weeks ago
Genentech is seeking a highly skilled Manufacturing Engineer to support the development and production of innovative cell and gene therapies. As a key member of our Manufacturing team, you will play a crucial role in establishing manufacturing processes, controls, and procedures for new technologies.
Key Responsibilities:
- Support technology transfers and production of cell and gene therapies
- Collaborate with various teams to establish manufacturing processes and controls
- Lead the development of batch-related documentation, including manufacturing batch records and SOPs
- Collaborate with compliance and quality members to assess process risks and establish controls for product safety and efficacy
- Lead end-to-end manufacturing operations for clinical and/or commercial products
Requirements:
- Bachelor's degree in a relevant field, such as cellular or molecular biology or engineering
- 2+ years of relevant experience in the cell and/or gene therapy industry
- Experience authoring GMP documents, such as SOPs and batch records
- Experience working in a commercial or clinical GMP environment
- Ability to work off-shift hours to support business needs
Preferred Qualifications:
- Experience driving continuous improvement using LEAN methodologies
- Experience with data analysis software, ERP systems, and quality management systems
- Experience as a trainer or team lead
- Benchwork/lab work experience
About Genentech:
Genentech is an equal opportunity employer and 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.
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