Sr. Manager Lab Operations - Bioburden

Nelson Labs; Taylorsville (UT); On-site; USD 110,000 - 150,000; Full time

Job summary

Nelson Labs, part of Sotera Health, is seeking a strategic Senior Lab Operations Manager to lead the Bioburden team within QA. You will oversee day-to-day operations, drive KPIs, and ensure high-quality microbiological testing services for medical devices and pharmaceuticals.

You will manage ~40 staff, collaborate with Quality, Sales, Consulting and Operations, develop processes, plan budgets, and champion continuous improvement, data integrity, and regulatory compliance in a regulated

Qualifications

• Minimum 5 years of experience in Laboratory operations.
• Experience in regulated environments (GMP, GLP, ISO).
• Strong microbiology knowledge and hands-on lab experience.
• Validation experience with equipment and facility.
• Experience leading teams in regulated medical device or pharma environment.

Responsibilities

• Lead day-to-day Bioburden lab operations and KPI delivery.
• Drive quality, turnaround times, utilization, and efficiency.
• Develop and execute process improvements for scalability.
• Staffing, workflow optimization, and resource planning.
• Budget planning, forecasting, and cross-functional collaboration.

Skills

Laboratory operations

Manufacturing operations

Leadership in regulated environments

Microbiology knowledge

Hands-on laboratory experience

Operational leadership

Education

Bachelor’s degree in Biology

Bachelor’s degree in Microbiology

Tools

Equipment validation

Facility validation

Job description

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 SummaryNelson 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 ResponsibilitiesOperational LeadershipLead day-to-day laboratory operations for the Bioburden departmentDrive departmental KPIs including quality, turnaround times, utilization, and operational efficiencyDevelop and execute process improvement initiatives to enhance performance and scalabilityEnsure adequate staffing, workflow optimization, and resource planning to meet customer expectationsPartner with leadership on budget planning, capital expenditures, forecasting, and long-term operational strategyStrategic Business SupportSupport profitable growth initiatives and expansion of laboratory capabilitiesCollaborate with Sales and Consulting teams to strengthen customer partnerships and service offeringsLead efforts to improve customer experience and operational competitivenessPeople Leadership & Talent ManagementLead, coach, and develop managers and laboratory staffConduct regular one-on-ones and performance discussionsDrive employee engagement, succession planning, and talent retention initiativesFoster a culture of accountability, collaboration, safety, and continuous improvementQuality & Regulatory ComplianceEnsure compliance with GMP, GLP, ISO, and applicable regulatory standardsPartner with Quality Assurance to investigate trends and implement corrective actionsMaintain strong focus on data integrity, procedural compliance, and laboratory quality systemsCross-Functional CollaborationWork across departments to improve operational alignment and customer deliverySupport integration activities related to operational changes, acquisitions, or business initiativesAct as a change leader within the organizationQualificationsRequired ExperienceMinimum 5 years of experience in:Laboratory operationsManufacturing operationsLeadership within regulated environmentsStrong microbiology knowledge and operational leadership experienceHands-on laboratory experience requiredValidation experience required, specifically:Equipment validationFacility validationExperience leading teams in a regulated medical device, pharmaceutical, or related environmentPreferred BackgroundTissue manufacturingLaboratory operations managementMedical device or pharmaceutical manufacturingRadiation sterilization or microbiological testing environmentsEducationBachelor’s degree required, preferably in:BiologyMicrobiologyRelated scientific disciplineSotera 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.