Genentech discovers, develops, manufactures and commercializes treatments for patients with serious and life-threatening medical conditions. Backed by North Carolina Biotechnology Center.
About the role
The Holly Springs Quality Control Team is seeking an experienced and dynamic leader to establish and head our Analytical Sciences and Technology team.
What they're looking for
- You have experience in stability program ownership for a commercial manufacturing site
- You have in-depth working knowledge of cGMP operations, ICH guidelines, and global Health Authority regulatory requirements (FDA, EMA, etc.)
- You have proven technical leadership capabilities and demonstrated project management skills, with a track record of effectively managing workload distribution, timelines, and competing priorities
- You have extensive experience in deviation investigation
More about this role
Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing.
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 meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028.
Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation.
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