Manufacturing Engineer (Cell & Gene Therapy)
About The Position
Our Hillsboro Individualized Therapies (HIT) team at Genentech is at the forefront of bringing new medical advancements from development stages to commercial manufacturing. As a member of our Manufacturing team, you will have the unique opportunity to work with cutting-edge technologies such as individualized DNA/RNA therapies, cell therapies, and stem cell therapies. You will play a crucial role in supporting multi-phase technology transfers and production, collaborating with experts in Manufacturing Sciences and Technology (MSAT), and ensuring the highest standards of quality and safety for our innovative therapies. This role offers a dynamic and diverse range of responsibilities, where you will have the chance to work collaboratively with various departments and contribute to the advancement of healthcare for patients in need. The Opportunity: As a Manufacturing Engineer (Cell Therapy), your main responsibility will be to support technology transfers and production of innovative cell and gene therapies. You will work collaboratively with various teams to establish manufacturing processes, controls, and procedures, while transferring new technologies to the site. You will play a key role in onboarding new equipment and processes in collaboration with our MSAT and compliance teams. Additionally, you will:
Requirements
- You possess a Bachelor’s degree and 2 or more years of relevant manufacturing cell and/or gene therapy industry experience.
- You have experience authoring GMP documents such as SOPs and Batch Records.
- You have experience working in a commercial or clinical GMP environment.
- You have experience supporting root cause analysis and developing corrective actions.
- You are available to work off-shift hours to support business needs. Shifts are typically 8 hours on Mon-Fri, but overtime and altered schedules will sometimes be required to support operations. These can include weekends, evenings, and nights.
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 (working in biosafety cabinets, pipetting, PCR, purification, open and closed cell culture, aseptic technique, etc.).
- Experience managing deviations in a GMP environment or supporting impact assessments.
- Knowledge of Health Authority requirements.
Responsibilities
- Lead the development of batch-related documentation, including manufacturing batch records, SOPs, training materials, and associated forms
- 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, encompassing solutions/buffer preparation, cell culture, gene editing, cellular isolations, guided stem cell differentiation, filtration, chromatography, formulation, fill-finish, and aseptic operations
- Drive process improvements and efficiencies using LEAN methodologies, implementing standard work, and maximizing productivity
- Utilize single-use technology, new analytical techniques, and digital manufacturing systems to optimize bioprocess facility capacity
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
