Sr. Lab Operations Manager - Sterilization

Sotera Health

$90K — $120K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years in laboratory operations and manufacturing/validation-focused roles
  • Strong leadership experience in regulated industries
  • In-depth knowledge of microbiology
  • Hands-on laboratory experience essential
  • Validation expertise in both equipment and facility validation preferred
  • Experience in sterilization validation environments is highly desirable

Responsibilities

  • Lead daily operations of the Sterilization department
  • Oversee EO and steam sterilization validation activities
  • Drive improvements in operational efficiency and production performance
  • Provide technical guidance in sterilization processes and regulatory compliance
  • Optimize laboratory resources, staffing, and workflows
  • Support growth initiatives in the Sterilization department
  • Collaborate with cross-functional teams to enhance customer service offerings

Benefits

  • Employee development and performance management support
  • Opportunities for succession planning and mentorship
  • Collaborative and accountable workplace culture
  • Focus on training programs for technical competency
  • Commitment to regulatory compliance and quality assurance initiatives
Full Job Description
Position Summary

Nelson Labs is seeking a highly strategic and technically strong Senior Lab Operations Manager (Sr. LOM) to lead our Sterilization team within the Quality Assurance organization.

This team focuses on sterilization validation services, specifically Ethylene Oxide (EO) and steam sterilization validations for medical device and pharmaceutical products. The Sr. LOM will oversee approximately 16 employees, including 3-4 direct reports, and will play a key role in driving operational growth, technical excellence, customer satisfaction, and continuous improvement initiatives.

This role requires a leader with strong validation and operational experience who can strategically grow the business, improve efficiencies, and strengthen technical capabilities within the department.

Key Responsibilities

Operational & Technical Leadership
  • Lead daily operations for the Sterilization department
  • Oversee sterilization validation activities including EO and steam sterilization programs
  • Drive operational efficiency, turnaround time improvements, and production performance
  • Provide technical leadership in sterilization validation processes and regulatory compliance
  • Ensure laboratory resources, staffing, and workflows are optimized to support business needs

Strategic Growth & Business Partnership
  • Support departmental growth initiatives and expansion opportunities
  • Partner with Sales, Consulting, and Operations teams to enhance customer service offerings
  • Contribute to operational strategy and long-term planning initiatives
  • Drive operational excellence and process improvement efforts

Team Leadership & Development
  • Lead and mentor direct reports and laboratory personnel
  • Support employee development, succession planning, and performance management
  • Foster a collaborative, accountable, and customer-focused culture
  • Guide training program development to support technical competency and business continuity

Quality & Compliance
  • Ensure compliance with GMP, GLP, ISO, and company quality standards
  • Maintain focus on regulatory readiness, procedural adherence, and data integrity
  • Partner with Quality Assurance to address quality trends and corrective actions

Cross-Functional Collaboration
  • Work collaboratively across departments to support customer delivery and operational alignment
  • Serve as a change advocate during organizational and operational initiatives


Qualifications

Required Experience
  • Minimum 5 years of experience in:
    • Laboratory operations
    • Manufacturing or validation-focused operations
    • Leadership within regulated industries
  • Strong microbiology knowledge required
  • Hands-on laboratory experience required
  • Validation experience required, including:
    • Equipment validation
    • Facility validation
  • Experience in sterilization validation environments strongly preferred


Preferred Background

Strong candidates may come from:
  • Sterilization facilities
  • Medical device manufacturing
  • Validation-focused operations
  • Manufacturing leadership environments

Experience with the following is highly preferred:
  • Ethylene Oxide (EO) sterilization
  • Steam sterilization
  • Sterility assurance programs

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

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