Senior Manager, Manufacturing; GMP

Novel Biotechnology USA, Inc., located in scenic Vancouver, Washington, just across the Columbia River from Portland, Oregon, is a CDMO on a mission to make cutting-edge genetic medicines more accessible by providing cost-effective and efficient plasmid DNA manufacturing services. We're a team of about 25 people, and we're expanding into GMP manufacturing in 2027. We move quickly, and everyone here contributes directly to getting product out the door and supporting the programs our clients are advancing toward patients.

Vancouver, WA puts you in one of the most livable corners of the country. Washington has no state income tax, so your paycheck goes further, while Portland's food, coffee, arts, and music scene is just across the river. Weekends are hard to beat: hike the Columbia River Gorge, ski or climb Mt. Hood, explore Mt. St. Helens, or head to the Oregon coast or wine country, all within an easy drive.

With Portland International Airport about 15 minutes away, traveling is simple. If you've been looking for a place where you can do meaningful work during the week and get outside on the weekend, this is it.

This is a build role. We're bringing GMP plasmid manufacturing online for the first time, and we need a hands-on manufacturing leader to make it happen. Over the next 12-18 months, you'll help build out our new facility and its GMP cleanroom suites and get our processes, people, and documentation GMP-ready. Along the way, you'll own day-to-day manufacturing of our clinical-grade material so our technical leadership can focus on strategy, process development, and growth.

You won't be doing it alone. You'll work closely with experienced GMP and plasmid manufacturing leaders who have done this before, and our current processes already operate close to GMP standards. You'll have real guidance and backup, plus genuine ownership of the work.

This is a player-coach role. You'll lead the manufacturing team, and you'll also be on the floor.

You'll step into a suite when the schedule demands it, troubleshoot a run alongside your team, and review a batch record line by line. We want someone who has built good operational habits through real experience and still likes doing the work, not someone who needs a large administrative structure around them to be effective. For the right person, this is a step into a role with significant room to grow as the company scales.

• Partner with leadership on the build-out of our new Vancouver facility, including GMP cleanroom suites, from design input through equipment specification, installation, and qualification
• Define GMP-compatible materials, receiving processes, and equipment needs, and drive procurement and qualification
• Guide the transition of processes and documentation from high-quality grade to GMP, including gowning and cleanroom practices
• Establish the operational systems (scheduling, shift structure, training matrices, performance metrics) that will support the business as it grows
• Own suite and equipment scheduling, production planning, and shift coverage to meet customer timelines.
• Oversee execution of plasmid manufacturing processes, including fermentation, harvest, lysis, purification (chromatography, TFF), and fill/finish
• Monitor on-time delivery, right-first-time execution, and throughput, and drive improvements where performance falls short
• Collaborate with process development, QC, supply chain, and project management so that materials, testing, and handoffs don't hold up production
• Act as the first escalation point for operational issues on the floor

• Supervise manufacturing staff directly: set expectations, give feedback, and hold…