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 shift depends on business needs. You must be able to work all shifts (1st, 2nd, or 3rd, weekends, 12 or 10 hours). Require overtime as needed.

This position is located on-site in Hillsboro.

The Opportunity:

As a Manufacturing Engineer, 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:

• Own 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 4 years of relevant cell and/or gene therapy industry experience

• You have experience authoring and reviewing GMP documents such as SOPs, Batch Records, Learning Curriculum, Development Protocols and Qualification Documents

• You have experience working in a commercial or clinical GMP environment

• You have experience with technology transfers

• You have experience as a trainer or leading a small team

• You are available to work off-shift hours to support business needs

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

• 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

• Experience with New Product Introductions

• Change Control

• Knowledge of Health Authority requirements

Work Environment/Physical Demands/ Safety Considerations:

• Stand for extended periods.

• Ability to lift 25 pounds
• Ability to gown in grade B cleanroom
• Ability to work in clean room for four hours at a time
• Must be able to pass the vision test for product inspection (this is the jaeger, but also has other modules including color and visual acuity)
• Must be able to pass the medical exam for cleanroom entry (our local nurse checks for skin conditions that aren't allowed in the cleanroom)

Genentech 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.