Senior Manager, Manufacturing (GMP)

Novel Bio; Vancouver (WA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Equity participation

Relocation support

Medical, dental, and vision benefits

Flexible PTO policy

Opportunity to build GMP operation

Job summary

Novel Bio is building GMP plasmid manufacturing in Vancouver, WA. We seek a hands-on manufacturing leader to own day-to-day GMP operations, steward new facility build-out, and drive process readiness while managing a growing team.

You will work directly with senior GMP leaders to ensure timely delivery, quality, and compliance as we scale from startup toward commercial production. This role requires on-site presence and a practical, go-below-the-line mindset.

Qualifications

• Requires hands-on biologics GMP manufacturing experience.
• Strong leadership of manufacturing staff and training programs.
• Experience with deviations, CAPA, change control, and batch records.

Responsibilities

• Oversee day-to-day GMP plasmid manufacturing operations on the floor.
• Lead and develop the manufacturing team, including hiring and training.
• Collaborate with QA to manage deviations, investigations, and CAPAs.
• Own scheduling, production planning, and shift coverage to meet timelines.
• Review batch records line by line and ensure GMP readiness.
• Work on-site in Vancouver, WA, with hands-on leadership and problem-solving.

Skills

Leadership

GMP experience

cGMP knowledge

CAPA deviations

Batch record execution

Production scheduling

Education

Bachelor's degree in biology/biochemistry/chemical engineering

Job description

About Us

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.

Life in the Pacific Northwest

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.

The Role

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.

What You'll Do

Build our GMP operation

• 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

Lead and develop the team

• Supervise manufacturing staff directly: set expectations, give feedback, and hold people accountable to procedures and standards
• Own the manufacturing training program, including curricula, on-the-job training, qualification of operators, and training records
• Hire and onboard new team members as we scale into GMP
• Build a culture where people take pride in doing it right, speak up about problems, and want to stay and grow

Partner with Quality

• Work with QA on deviations, investigations, root cause analysis, and CAPAs, and make sure corrective actions actually get implemented on the floor
• Own manufacturing's side of change control
• Author, revise, and review SOPs, batch records, and other controlled documents
• Maintain inspection readiness and support client audits

What You Bring

Required

• Bachelor's degree in biology, biochemistry, chemical engineering, or a related field, or equivalent experience
• 6-10 years of hands-on experience in biologics manufacturing
• At least 2-3 years directly supervising manufacturing staff
• Working knowledge of cGMP requirements (21 CFR 210/211, ICH Q7/Q10 or equivalent) and experience operating in a GMP environment
• Direct experience with deviations, CAPA, change control, and batch record execution and review
• Experience with plasmid DNA manufacturing; adjacent GMP experience (e.g., mRNA, viral vectors, antibodies/proteins, enzymes, cytokines/growth factors) is also welcome with demonstrated understanding of how GMP expectations differ by product class and stage
• Proven ability to schedule and balance multiple production priorities

Preferred

• Experience starting up a new GMP facility, cleanroom suite, or bringing a process into GMP
• Experience in a CDMO or other client-facing manufacturing setting
• Experience in a small company or startup where you wore multiple hats

How You Work

• Builder. You want to build something from the ground up, take ownership without being asked, and are motivated by the chance to grow with the company.
• Disciplined. You believe good manufacturing comes from good habits, and you hold yourself and your team to high standards every day.
• Hands-on. You're comfortable gowning up, running a process, writing the SOP, and solving problems at the bench, and you lead by example.
• Sound judgment. You know how to right-size compliance: rigorous where it matters, practical where it doesn't.
• Firm and fair. You set clear expectations and address problems directly, and people want to work for you because you're respectful, consistent, and invested in their success.
• Clear communicator. You keep leadership informed, tell people what they need to hear early, and write clearly.
• On-site role with regular work in cleanroom and lab environments, including gowning
• This role may require extended travel
• Occasional off-hours, weekend, or on-call coverage to support production
• Ability to stand for extended periods

What We Offer

• Equity participation
• Relocation support
• Medical, dental, and vision benefits
• Flexible PTO policy
• The opportunity to build a GMP operation from the ground up and grow with it

Novel Bio is an equal opportunity employer. We are committed to building a diverse and inclusive team, and we welcome applicants from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, marital status, pregnancy, disability, genetic information, veteran or military status, or any other characteristic protected by federal, state, or local law. If you need a reasonable accommodation at any point during the application or interview process, please let us know. Candidates must be legally authorized to work in the United States; Novel Bio is unable to sponsor or take over sponsorship of employment visas for this role, now or in the future. All offers are contingent on completion of Form I-9, including providing acceptable documents to verify identity and employment authorization, and our hiring process includes verification of employment history and education.