Manufacturing Engineer

Genentech - Hillsboro, OR

Full-time

Hillsboro, OR

Chemical Manufacturing

About the position

The Manufacturing Engineer position at Genentech's Hillsboro Individualized Therapies (HIT) team involves supporting the technology transfers and production of innovative cell and gene therapies. This role is crucial for ensuring the highest standards of quality and safety in the manufacturing process, collaborating with various departments, and contributing to advancements in healthcare. The position offers a dynamic range of responsibilities, including the development of manufacturing processes and documentation, and driving process improvements using LEAN methodologies.

Responsibilities

• Support technology transfers and production of cell and gene therapies.
• Lead the development of batch-related documentation, including manufacturing batch records, SOPs, and training materials.
• 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, including solutions/buffer preparation, cell culture, gene editing, and aseptic operations.
• Drive process improvements and efficiencies using LEAN methodologies and implement standard work to maximize productivity.
• Utilize single-use technology, new analytical techniques, and digital manufacturing systems to optimize bioprocess facility capacity.

Requirements

• Bachelor's degree and 2 years of relevant cell and/or gene therapy industry experience.
• Experience authoring GMP documents such as SOPs and Batch Records.
• Experience working in a commercial or clinical GMP environment.
• Experience supporting root cause analysis and developing corrective actions.
• Proficient in reading, writing, and communication in the English language.

Nice-to-haves

• Bachelor's degree in cellular or molecular biology or engineering.
• Experience driving continuous improvement using LEAN methodologies.
• Experience with data analysis software, ERP systems, Manufacturing Execution Systems, and quality management systems.
• Experience as a trainer or team lead.
• Benchwork/lab work experience in biosafety cabinets, pipetting, PCR, purification, and aseptic technique.
• Experience managing deviations in a GMP environment or supporting impact assessments.
• Knowledge of Health Authority requirements.

Benefits

• Discretionary annual bonus based on individual and Company performance.