Senior Manager, Operations Lead (Compounding, Filling, and Inspection)

Welcome to Holly Springs, North Carolina— home to Genentech's largest-ever investment with an ambitious goal to be a fully connected Plant of the Future. This is where next-generation technology, capability, digital connectivity and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. This will include Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products.

The facility's core is defined by innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant will not only meet today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines but is a strategic commitment to be scalable with this portfolio, which serves one of the largest patient populations in the world. This is a fast-paced, highly entrepreneurial environment with a high-level of accountability from the site team to launch operations in 2028. 

Are you a problem-solver and change agent who thrives in a High-Performing Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to not only launch a state-of-the-art facility from the ground-up but to shape the culture of our organization for the next generation. 

Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine.

The Opportunity:

We're seeking a highly experienced and strategic Operations Lead to play a pivotal role in ensuring safe, cost-effective, and efficient fill finish operations, while maintaining compliance with cGMPs, regulatory guidelines from Health Authorities, and Genentech quality policies.During the project phase, you will be an integral member of the User Team and will provide scientific and technical leadership for the new large volume manufacturing facility in Holly Springs.  In partnership with the Engineering and the start-up project (user) team, you will  partner and collaborate with our partner organizations (Engineering, MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy) to provide expertise in project management and technical design, testing, qualification, validation, as well as all other activities related to design and start-up a new Drug Product Fill and Finish facility. This role specifically is about ensuring validation and operational readiness of the facility’s compounding, inspection and visual inspection lines. Following the go-live of the facility, you will transition into a routine position with responsibilities of daily manufacturing operation.  

This role requires you to be onsite fill time, initially at the Genentech project office before transitioning on-site once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase.During this time:

• You will support the project leadership and co-lead project teams thereby driving optimal greenfield facility and operations design towards high manufacturing efficiency and quality in line to meet product and cGMP/regulatory requirements. You will champion self-initiated or assigned parts of the project within the context of project and company objectives, and justify goals towards management. This also includes provision and realization of creative ideas to drive business and project efficiency and may contain connecting manufacturing technology advances and digital transformation aspects.

• Together with the suppliers and contractors, you will build all required processes, documents, tests to transition the design plans into a functioning, approved manufacturing process. 

• You will foster a positive safety culture in which no one gets hurt and ensure the integration of environmental health, safety, and security into the business and manufacturing processes, systems, and programs while reporting safety and environmental incidents within one’s functional area.

• You understand the bigger picture of the project and large volume low cost manufacturing as part of the CVRM disease area and how Pharma Technical (PT) contributes to it. You will work closely with the overall project team, the wider organisation and interdepartmental staff to meet department and company goals. You will effectively partner with and influence stakeholders across the broader organization without formal authority, and drive technical decisions balancing project, product, quality/regulatory and operations views. 

• You will provide knowledge and training on complex process and equipment techno