US Operations Director — Scale Medical Device CDMO

Nextern, Inc.; Maple Grove (MN); On-site; USD 180,000 - 300,000; Full time

Benefits offered by this job

Health care plan

Retirement plan with company match

Paid time off

Birthday holiday

Life insurance

Family leave

Disability

Taco Thursdays

Job summary

Nextern, Inc. in Minnesota seeks a Director of US Operations to lead the end-to-end performance of our US CDMO site. You own site P&L, build scalable structure, and guide the organization from development-phase to high-volume commercial manufacturing with quality and cost in focus.

You will lead a cross-functional team, establish KPI cadence, drive continuous improvement, and ensure regulatory readiness. The role partners with business development, program management, quality, and finance to

Responsibilities

• Design scalable site organizational structure aligned to growth and regulatory requirements.
• Recruit, develop, and retain operations leaders across manufacturing, supply chain, quality, engineering, and facilities.
• Establish clear roles, accountabilities, and decision rights across operations.
• Foster transparency, urgency, and continuous improvement in a fast-paced CDMO environment.
• Drive alignment between site operations and corporate strategy with cascaded goals.
• Define and own site KPI framework for safety, quality, delivery, and efficiency.
• Establish daily/weekly/monthly operational review cadence to drive data-driven decisions.
• Lead root cause analysis and corrective action processes with timely closures.
• Champion lean manufacturing and 5S, Kaizen, and VSM to reduce waste.
• Benchmark performance against industry standards and drive improvement.
• Support NPI transitions from development to full commercial production with capacity planning.
• Partner with BD and PM to translate client pipeline into operational readiness plans.
• Lead capital expenditure planning, equipment acquisition, and facility expansion.
• Develop and maintain 12–36 month capacity plans balancing demand and regulatory timelines.
• Serve as senior operational contact for key client relationships, with transparency on capabilities and risks.
• Ensure compliance with 21 CFR Part 820, ISO 13485, and applicable regulatory frameworks.
• Own site operating budget, headcount, and capital budgets; deliver financial commitments.”
• Identify and execute cost reduction and productivity initiatives without compromising quality or delivery.
• Provide accurate operational forecasts and variance analysis to senior leadership.
• Translate multi-year strategy into annual operational plans with clear milestones and owners.
• Lead change management and cross-functional alignment to sustain momentum.

Job description

Nextern, Inc. in Minnesota seeks a Director of US Operations to lead the end-to-end performance of our US CDMO site. You own site P&L, build scalable structure, and guide the organization from development-phase to high-volume commercial manufacturing with quality and cost in focus.

You will lead a cross-functional team, establish KPI cadence, drive continuous improvement, and ensure regulatory readiness. The role partners with business development, program management, quality, and finance to