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.
Responsibilities
- Support technology transfers and production of innovative cell and gene therapies.
- Establish manufacturing processes, controls, and procedures while transferring new technologies to the site.
- 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.
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.
- Availability to work off-shift hours to support business needs.
- 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 (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.
Benefits
- Discretionary annual bonus based on individual and Company performance.
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