The Position

Essential Functions:

• Understand and communicate manufacturing best practices at the site and communicate minimum requirements to the core project team to ensure manufacturability and scalability
• Be the Global Operations project focal and ensure that all Operations stakeholders (Manufacturing, Process Engineering, Validations Engineering, Functional Leads, Quality, Validation, Planning, Procurement, Purchasing and Label Control) needs are understood and communicated through the transfer process
• Actively establish and refine Technology Transfer standard work to continuously improve the transfer process
• Actively use project management techniques to plan, track and ensure timely completion of transfer projects
• Utilizes expertise in site manufacturing processes to promote, train and improve GMP within the site to ensure transfer activity is successful from cost, quality and delivery perspective
• Effectively incorporate manufacturing requirements into development projects to ensure robust technical transfer into operations by providing input at the design stage for design for manufacturing
• Define, lead and execute Validation protocols utilizing Good Manufacturing Processes (GMP) and standards for transferred products
• Participates in and/or leads cross-functional teams to ensure the needs of the technology transfer project are met. Establishes partnerships across other organizational groups (Lifecycle, Regulatory and other business partners) as required
• Troubleshoots problems. Participates in transfer planning and process updates. Prepares and delivers presentations of project results to others; presents data to larger and more diverse audiences

• Demonstrates the ability lead projects and is able to navigate moderate complexity technical, regulatory and business. May be given Project Lead special assignments with oversight from other team members
• Demonstrates the ability to deliver results with a moderate guidance and input from others
• Other duties as assigned by management.

MINIMUM QUALIFICATIONS:

Formal Training/Education:

• Bachelor's degree in an Engineering/Engineering Technology or Life Science discipline degree required
• MS in an Engineering/Engineering Technology or Life Science discipline preferred

Experience:

• Minimum of 3-5 years of mechanical/manufacturing systems development/technology transfer
• MS in Engineering: 2-3 years of experience in mechanical/manufacturing systems

Equivalent combination of education and/or experience may be accepted upon management and HR review

Knowledge, Skills, and Abilities:

• Demonstrates potential for technical proficiency, scientific creativity, collaboration with others, and independent thought
• Strong understanding of assay, bulk and reagent manufacturing processes and design and the ability to apply scientific method as it relates to production
• Advanced technical writing skills to produce reports and documents
• Ability to apply 6 Sigma and Lean Manufacturing Methods during the development phase
• Ability to utilize systems such as SAP and ETQ

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.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.