Vice President, Operations
Each year, more than 150,000 breast reconstruction procedures are performed in the U.S., yet one in three patients still faces a serious complication. That is not good enough. At Elutia, we are working to change it.
Our mission is to humanize medicine so patients can thrive without compromise. We are pioneering drug-eluting technologies to improve the interface between medical devices and the patients who rely on them.
How we work matters just as much as what we make. Elutia is a certified Great Place to Work®, grounded in our CRU values: Contagiously Confident, Ridiculously Relentless, and Unanimously United. We set a high bar for ourselves, for each other, and for the outcomes we deliver.
Our team is All In on the mission. This is not the place for someone looking to coast. It is the place for someone who wants to solve hard problems, move with urgency, and make a real mark on medicine, alongside a team fully committed to improving patient outcomes.
Position Overview.
The Vice President of Operations serves as Site Head for Elutia’s manufacturing facility in Gaithersburg, Maryland. Reporting directly to the CEO, this “roll-up-your-sleeves” executive will lead the operational build, launch, and scale-up of a complex GMP manufacturing site producing drug-device combination products. This is a high-impact, on-site leadership role for someone who can execute in the real world of regulated manufacturing, where the stakes are high, the standards are unforgiving, and the work matters.
This is not a steady-state maintenance role. The mandate is to build something exceptional, scale it the right way, and do it with urgency, discipline, and grit.
- Strategic Leadership and Site Management
- Serve as the Site Head with full accountability for the Gaithersburg facility.
- Function as a core member of the Leadership Team, contributing to corporate strategy and ensuring operational alignment with company-wide milestones.
- Lead the transition from facility build-out to full-scale commercial launch and sustained high-volume production.
- Drive a culture of “CRU”—Contagiously Confident, Ridiculously Relentless, and Unanimously United—across all levels of the manufacturing organization.
- Build, develop, and lead a high-performing team that thrives in a high-standard environment—driving accountability, ownership, and a shared commitment to delivering exceptional outcomes.
Manufacturing and Technical Operations
- Oversee the successful tech transfer of drug-device combination products into the manufacturing suite.
- Drive the operationalization of complex manufacturing processes, ensuring adherence to rigorous GMP standards.
- Implement scalable production systems designed for efficiency, yield optimization, and consistent output of life-saving medical technologies.
- Identify and implement sourcing and manufacturing improvements to continually lower cost and reduce external dependencies, without impacting quality.
Quality Compliance
- Maintain direct oversight of the Quality function, ensuring that quality systems are integrated into the fabric of daily operations.
- Ensure the facility remains in a constant state of audit readiness and compliant with all FDA and international regulatory requirements for combination products.
- Foster a culture of technical excellence where quality is viewed as a competitive advantage rather than a checkbox.
- Evaluate the current quality systems and optimize approaches based on a robust risk assessment, while minimizing administrative burden.
Operational Excellence
- Build and mentor a high-performing operations and quality team capable of navigating the complexities of drug-eluting biomatrix technologies.
- Manage site-level P&L, resource allocation, and capital expenditure projects.
What You bring:
Education & Experience
- 15+ years of operations or engineering leadership in the medical device, pharma or biotechnology industry. GMP manufacturing experience preferred.
- Bachelor’s degree required. Advanced degree preferred.
- Site Head experience or a proven track record managing an entire manufacturing facility in a regulated environment.
Technical & Regulatory Expertise
- Deep expertise in drug-device combination products and the specific regulatory frameworks governing them (21 CFR 4.4).
- Direct experience in launching medical device manufacturing facilities and production processes from the ground up.
- Demonstrated success in complex tech transfers under tight deadlines.
- Experience with direct FDA inspections is highly preferred.
Leadership Profile
- Must be on-site full-time in Gaithersburg; remote or hybrid arrangements are not applicable for this role.
- Exceptional problem-solving skills with the ability to anticipate and proactively resolve bottlenecks.
Who Thrives Here
This place isn’t for everyone. At Elutia, we are All In on the mission. This place is built for people who want to compete at a high level, solve hard problems, and do work that matters deeply to patients. The people who thrive here are confident without being arrogant, relentless without being rigid, and team-first to the core. They do not seek comfort, politics, or a carefully managed environment. They want the challenge. They want the ownership. They want to be on a team with other exceptional people and win.
For a Vice President of Operations, this isn’t a job. It is a mission. Priorities shift. Problems hit fast. Constraints are real. We are looking for the leader who thrives here, rises to the moment, course-corrects unapologetically, and keeps the team locked on the goal line. If someone is looking for comfort, clean boundaries, or a lower-stakes ride, this is the wrong place. If they want to build something meaningful with a team of superstars and leave everything on the field, they will belong here.
- All in on the mission
- Confident, not arrogant
- Calm under pressure and decisive in critical moments
- Obsessed with outcomes, not status
- Fast to adapt and hard to rattle
- Patient-first
- Energized by hard problems and high standards
- More interested in winning championships than MVPs
Compensation & Benefits
Expected salary range: $240,000 – $300,000, depending on experience and qualifications.
This role is eligible for equity and performance-based bonus. Elutia also offers a comprehensive benefits package, including medical, dental, vision, life, 401(k) with employer match, and paid time off.