Manufacturing Engineer

6 days ago

Hillsboro, United States Genentech, Inc. Full time

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:
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

Who You Are:
You possess a Bachelor's degree and 2 years of relevant 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.
You are proficient in reading, writing, and communication in the English language.

Preferred:
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

Relocation benefits are not available for this posting. This is an on-site position.The expected salary range for this position based in Oregon is $65,000 (min) - $92,600 (mid) - $120,800 (max). Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.BenefitsGenentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech 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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