Sr. Manager Lab Operations - Bioburden

Sr. Manager Lab Operations - Bioburden

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.