Backed by 500 Global.
About the role
As a candidate you bring in deep expertise across mammalian manufacturing (upstream and downstream), large-scale cell culture, and MSAT operating systems—paired with executive-level leadership, client-facing presence, and a track record of ramping greenfield facilities to commercial performance. Make an impact and lead a large-scale mammalian drug substance operation from greenfield to sustained commercial excellence.
What they're looking for
- Strategy and operating system
- Define and govern the process control strategy linking CQAs to CPPs, establish ranges, control plans, and alignment with Manufacturing, Quality, and Engineering
- Institutionalize a tiered governance model, leader standard work, pre-/in-/post-flight controls, process monitoring boards, and escalation pathways to ensure proactive risk management and stable operations
- Mammalian tech transfer, validation, and stewardship
- Lead PPQ readiness and delivery, drive digital/PAT adoption and continuous improvement for scale, repeatability, and cost efficiency
- Investigation excellence and compliance
More about this role
As a candidate you bring in deep expertise across mammalian manufacturing (upstream and downstream), large-scale cell culture, and MSAT operating systems—paired with executive-level leadership, client-facing presence, and a track record of ramping greenfield facilities to commercial performance. Make an impact and lead a large-scale mammalian drug substance operation from greenfield to sustained commercial excellence. Partner with the Site Leadership Team to shape the strategy, people and platforms that define best-in-class MSAT and manufacturing performance. Partner with Operations, Quality, Engineering, Automation and Supply Chain to deliver life-changing biologics to our patients across the globe.
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to...
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