Sr. Manager Lab Operations - Bioburden

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company's unwavering commitment to its mission, Safeguarding Global Health.

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Position Summary

Nelson Labs is seeking a strategic and operationally focused Senior Lab Operations Manager (Sr. LOM) to lead our Bioburden team within the Quality Assurance organization. This role is responsible for overseeing laboratory operations, driving operational excellence, leading people and process improvements, and ensuring delivery of high-quality microbiological testing services.

The Bioburden team supports radiation sterilization validations and performs testing to measure sterilization effectiveness for medical device and pharmaceutical products. This is the largest team within the organization and requires a strong operational leader capable of managing a high-performing, technically complex environment.

The Sr. LOM will oversee approximately 40 employees, including 3 direct reports, and partner cross-functionally with Quality, Sales, Consulting, and Operations leadership to support business growth and customer success.

Key Responsibilities

Operational Leadership

• Lead day-to-day laboratory operations for the Bioburden department
• Drive departmental KPIs including quality, turnaround times, utilization, and operational efficiency
• Develop and execute process improvement initiatives to enhance performance and scalability
• Ensure adequate staffing, workflow optimization, and resource planning to meet customer expectations
• Partner with leadership on budget planning, capital expenditures, forecasting, and long-term operational strategy

Strategic Business Support

• Support profitable growth initiatives and expansion of laboratory capabilities
• Collaborate with Sales and Consulting teams to strengthen customer partnerships and service offerings
• Lead efforts to improve customer experience and operational competitiveness

People Leadership & Talent Management

• Lead, coach, and develop managers and laboratory staff
• Conduct regular one-on-ones and performance discussions
• Drive employee engagement, succession planning, and talent retention initiatives
• Foster a culture of accountability, collaboration, safety, and continuous improvement

Quality & Regulatory Compliance

• Ensure compliance with GMP, GLP, ISO, and applicable regulatory standards
• Partner with Quality Assurance to investigate trends and implement corrective actions
• Maintain strong focus on data integrity, procedural compliance, and laboratory quality systems

Cross-Functional Collaboration

• Work across departments to improve operational alignment and customer delivery
• Support integration activities related to operational changes, acquisitions, or business initiatives
• Act as a change leader within the organization

Qualifications

Required Experience

• Minimum 5 years of experience in:

• Laboratory operations

• Manufacturing operations

• Leadership within regulated environments

• Strong microbiology knowledge and operational leadership experience

• Hands-on laboratory experience required

• Validation experience required, specifically:

• Equipment validation

• Facility validation

• Experience leading teams in a regulated medical device, pharmaceutical, or related environment

Preferred Background

• Tissue manufacturing
• Laboratory operations management
• Medical device or pharmaceutical manufacturing
• Radiation sterilization or microbiological testing environments

Education

• Bachelor's degree required, preferably in:
• Biology
• Microbiology
• Related scientific discipline

Sotera Health goes to market through its three best-in-class businesses - Sterigenics, Nordion and Nelson Labs. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.