Director of US Operations

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

The Director of US Operations is a senior leadership role responsible for the end-to-end operational performance of Nextern’s US medical device contract development and manufacturing organization (CDMO) site. This individual owns site P&L accountability, leads a cross-functional operations team, and serves as the primary architect of organizational structure, operating cadence, and commercial delivery. The Director of US Operations plays a critical role in translating business growth into disciplined execution — building the systems, teams, and culture required to scale from development-phase production to high-volume commercial manufacturing while sustaining the quality, delivery, and cost performance expected by world-class medical device clients.

Organizational Design & Leadership

• Design and build a scalable site organizational structure aligned to growth stage, client commitments, and regulatory requirements.
• Recruit, develop, and retain high-performing operations leaders across manufacturing, supply chain, quality operations, engineering, and facilities.
• Establish clear roles, accountabilities, and decision rights across all operational functions.
• Foster a culture of transparency, urgency, and continuous improvement consistent with a fast-paced CDMO environment.
• Drive alignment between site operations and corporate strategy through structured communication and cascaded goal-setting.

Operational Excellence & Metrics

• Define, implement, and own the site-level KPI framework spanning safety, quality, delivery, efficiency, and people.
• Establish a rigorous operational review cadence — daily tier meetings, weekly ops reviews, monthly leadership scorecards — to drive data-driven decisions.
• Lead root cause analysis and corrective action processes for recurring performance gaps; hold the team accountable to closure timelines.
• Champion lean manufacturing and operational excellence methodologies (e.g., Kaizen, VSM, 5S) to eliminate waste and reduce variability.
• Benchmark site performance against industry standards and drive continuous improvement to close gaps.

Commercial Scale & Capacity Planning

• Support NPI in transition roadmap from development and pilot-scale manufacturing to full commercial production, including capacity modeling and resource planning.
• Partner with Business Development and Program Management to translate client pipeline into operational readiness plans in partnership with NPI.
• Lead capital expenditure planning, equipment acquisition, and facility expansion initiatives required to support commercial commitments.
• Develop and maintain a 12- to 36-month capacity plan that balances client demand, regulatory timelines, and financial constraints.
• Serve as a senior operational point of contact for key client relationships, providing transparency into site capabilities, risks, and performance.

Quality & Regulatory Compliance

• Ensure the site operates in full compliance with 21 CFR Part 820, ISO 13485, and applicable international regulatory frameworks.
• Partner with Quality leadership to maintain a state of continuous inspection readiness; lead site responses to FDA, notified body, and client audits.
• Embed quality ownership at the operations level — reinforcing the principle that quality is built in, not inspected in.

Financial & Business Performance

• Own the site operating budget, headcount plan, and capital budget; deliver financial commitments with discipline and accountability.
• Identify and execute cost reduction and productivity improvement initiatives that improve site margin without compromising quality or delivery.
• Provide accurate operational forecasts and variance analysis to senior leadership on a regular cadence.

Strategy Execution & Cross-Functional Alignment

• Translate multi-year business strategy into annual operational plans with clear milestones, owners, and success metrics.
• Align site operations with commercial, quality, regulatory, and finance functions to ensure seamless execution of business commitments.
• Lead change management initiatives — communicating context, building buy-in, and sustaining momentum through ambiguity.
• Perform other related duties as assigned by management.

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability
• Taco Thursdays!!!

Nexternis an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.