ESS Laboratory Operations Manager

Reporting Structure: This is a management position within Experimental Surgical Services (ESS) which is part of the Department of Surgery, within the University of Minnesota Medical
School. This position reports to the Assistant Professor and Director, ESS Laboratory.

Basic Function:
The ESS Laboratory Operations Manager (Manager) is responsible for personnel management, laboratory operations, and ensuring regulatory compliance in support GLP-regulated and non-
GLP translational research within the Experimental Surgical Services (ESS) Laboratory. Reporting to the ESS Director, the Manager exercises substantial judgment in the daily supervision of research staff and facilities, allocating resources across multiple concurrent studies, and ensuring laboratory operations remain inspection-ready in accordance with United States Food and Drug Administration (FDA), United States Department of Agriculture (USDA), International Organization for Standardization (ISO), University of Minnesota Institutional Animal Care and Use Committee (IACUC), and University of Minnesota requirements.

Duties and Responsibilities:

Advanced Personnel Management & Leadership - 25%

• Provide direct supervision and advanced operational leadership for ESS laboratory personnel supporting complex, concurrent research studies.
• Independently assign, prioritize, and adjust staff responsibilities based on study complexity, timelines, and regulatory requirements.
• Ensure personnel are trained, qualified, and documented for assigned GLP and non-GLP duties prior to study participation.
• Maintain oversight of training matrices, proficiency documentation, and role-specific qualifications.
• Conduct annual performance evaluations and contribute to hiring, onboarding, and corrective personnel actions as appropriate.
• Establish expectations and foster a high-performance research environment.

Laboratory Operations & Strategic Resource Allocation - 25%

• Direct daily laboratory operations with responsibility for integrating personnel, facilities, equipment, and methodologies across service lines.
• Exercise independent judgment in forecasting staffing needs, space utilization, and equipment availability to support program-level research demands.
• Ensure Study Directors and laboratory personnel have access to qualified personnel and operational resources required to meet protocol objectives and timelines.
• Serve as alternate Test Facility Management contact when the ESS Director / Study Director is unavailable, consistent with delegated authority.
• Coordinate animal transfers between internal and external facilities and facilitate veterinary documentation for interstate transport.
• Provide operational input to sponsors and investigators regarding feasibility, timelines, and resource requirements.

Scientific & Programmatic Contribution - 20%

• Apply advanced scientific expertise to support mechanistic and adjunct research activities particularly in the basic sciences aligned with ESS service lines of business, including but not limited to proteomics, metabolomics, transcriptomics and genomics.
• Contribute to continuous improvement of laboratory capabilities supporting translational research programs.
• Assist Director in business development efforts and relationship building / maintenance.
• Represent ESS in operational coordination with IACUC, Research Animal Resources (RAR), Facilities Management, Department of Surgery, Medical School, and external collaborators.
  

Regulatory Compliance Assurance - 10%

• Collaborate with the Director in the interpretation and application of 21 CFR Part 58 (GLP), FDA guidance, and institutional policies as they relate to personnel, facilities, and
  equipment.
• Partner with the Quality Assurance Unit (QAU) and Data and Compliance Analyst (DCA) to support internal and external audits, inspections, and regulatory interactions.
• Facilitate the maintenance of inspection-ready documentation, including organizational charts, training records, master schedules, and controlled SOPs.
• Lead responses to audit observations affecting laboratory operations, including root cause analysis, CAPA development, retraining, and documentation updates.
  

Facilities & Equipment Oversight - 10%

• Ensure laboratory facilities and equipment are suitable, qualified, maintained, and available to support regulated research activities.
• Oversee equipment maintenance, calibration, repair, and vendor service coordination in compliance with GLP expectations.
• Maintain complete and accurate facility and equipment records to support sponsor and regulatory inspections.
• Lead laboratory-side planning and execution of facility and equipment improvement projects.
  

SOPs, Documentation & Process Control & Improvement -5%

• Oversee the development, revision, implementation, and retirement of laboratory SOPs impacting personnel, facilities, and equipment.
• Ensure controlled documents accurately reflect current practices and regulatory requirements.
• Support preparation and revision of study templates, data forms, and reports to ensure accuracy, traceability, and regulatory acceptability.
• Identify and create systems for improving internal workflow processes.
  

Training & Professional Conduct - 5%

• Complete required institutional and ESS training and maintain documented proficiencies.
• Model professional, positive and polite behavior in all instances.

Supervision Received:
Reports to the ESS Director. Works in close collaboration with the Director to advance
programmatic, operational, and regulatory objectives.

Supervision Exercised:
Exercises direct supervisory authority over ESS personnel, including but not limited to GLP and non-GLP Study Directors, Surgeons, Surgical Technicians, Student Laboratory Technician
Supervisor, and Student Laboratory Technicians, or other personnel at the discretion of the ESS Director. Has authority to assign work, evaluate performance, recommend compensation actions, and initiate disciplinary actions in accordance with University and ESS policies.

Required Qualifications:

• BA/BS plus at least six years of relevant experience OR Master of Science (MS) degree in a scientific or related discipline plus at least four years of experience
• Minimum of three (3) years of demonstrated experience directly supervising and managing high-performing teams.
• Minimum of two (2) years of professional experience in a scientific or research environment.
• Experience managing projects and/or assets in excess of 1M in funding annually
• Experience working in a laboratory environment supporting regulated or complex research activities.
• Ability to maintain confidentiality with sponsors and clients.
• Work on-site within the laboratory during core lab hours (M-F, 7:00am-3:30pm)
• Ability to travel 10% of time.

Preferred Qualifications:

• Demonstrated capacity for independent judgment, leadership, and accountability consistent with an advanced research role.
• Experience leading US Department of Defense or associated projects / initiatives, or other personnel management / leadership experience in structured, high-accountability, highly regulated environments
• Proven ability to operate effectively within a highly matrixed organization, with demonstrated understanding of the operational, regulatory, and organizational impacts
  of management decisions.
• Experience with FDA, USDA, ISO, IACUC, or other regulatory governing bodies
• Demonstrates executive presence and is professional, positive and polite in all interactions.

The ESS Laboratory (Program) is a preclinical research laboratory that performs non-clinical translational research studies for the purpose of advancing medical technology and patient care. ESS serves as a core resource to internal University investigators and stakeholders, supporting interdepartmental and intercollegiate cross-disciplinary research program goals. Concurrently, the ESS lab maintains an independent and robust commercial research business, providing contracted research services to external national and international industry and academic partners.

Pay Range: $80,000-$100,000; depending on education/qualifications/experience

Time Appointment: 100% Appointment

Position Type: Faculty and P&A Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University offers a comprehensive benefits package that includes:

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost
• Employee Transit Pass with free or reduced rates in the Twin Cities metro area

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.

Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.

To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

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