The primary responsibility of this position is to directly oversee all aspects of Lions Gift of Sight (LGS) laboratory operations including determining tissue suitability and laboratory processing. This position ensures the laboratory is efficiently operating and in compliance with all eye banking standards and regulations. The Manager of Laboratory Operations manages all Eye Bank Scientists and Laboratory Coordinator(s). This position regularly collaborates with the Distribution and Quality Systems teams as well as the executive director. Addtionally, this position is responsible to maintain LGS’s technical policies and procedures (P&P) relating to tissue suitability and processing, maintenance of the laboratory facility, and ensure that they are up to date to current practices.

This position requires a manager that is proficient in aseptically handling tissue. The manager will be in the laboratory evaluating and processing tissue approximately one day per week. LGS is committed to providing the highest quality tissue and will provide training to become proficient in tissue evaluation and processing as needed.

This is a full time, Monday-Friday position, but will require weekend and evening hours. Administrative call (available by cell phone) is required at all times. Travel is required throughout the LGS coverage area and nationally for conferences. Personnel in this position are considered “Essential Employees” related to back-up or managerial responsibilities in this job description and are expected to report to work during emergency closings unless specifically informed by their supervisor that they are not to report.

Job Responsibilities:

60%: Oversee All Laboratory Operations

• Provide subject matter experise on transplant tissue suitability determination and tissue processing.
• Track directives, progress and evaluate program effectiveness; recommend and implement changes; participate in development and implementation of Operations Continuity Plan.
• Supervise literature review for research and development of new procedures. Collaborate with other eye banks and participate in the development of new methods, techniques, instrumentation and devices to improve tissue evaluation and processing.
• Manage all aspects of supply procurement and inventory for all eye bank operations (recovery, laboratory, research).
• Manage all aspects of equipment procurement, maintenance, calibration, certification and validation for laboratory.
• Oversee decontamination and sterilization procedures for all eye bank operations.
• In concert with Donor Eligibility, Recovery, Distribution and Quality Systems Managers and Director of Research and Development; ensure LGS follows all FDA and EBAA requirements regarding the storage of human ocular tissue.
• Evaluate and process tissue approximately one day per week.

20%: Regulatory Compliance and Quality Systems

• Ensure that Lions Gift of Sight (LGS) is compliant with all Federal Drug Administration (FDA) regulations and guidance and Eye Bank Association of America (EBAA) standards related to tissue suitability and processing and laboratory maintenance.
• Review LGS P&P relating to tissue suitability and processing at least annually or more frequently as needed and ensure these P&P's are accurate and in compliance with FDA and EBAA regulations and standards.
• Revise, originate or obsolete P&Ps and forms as needed and delegate first draft of policies to appropriate subject matter experts.
• Follow document control process: propose and revise policies, procedures or revisions for approval by Quality Systems and signature by Executive and Medical Directors.
• Ensure training is provided to appropriate personnel for all changes in P&Ps prior to implementation.
• Collaborate on eye bank database development, maintenance and training.
• In concert with Quality Systems ensure all laboratory equipment remains in compliance with FDA and EBAA requirements as it relates to calibration, certification and validation.
• Participate in inspections (FDA, EBAA) and internal audits, as assigned by Quality Systems. Collaborate in corrective and preventative actions and completion of Quality Control Reports as requested. Collaborate with Quality Systems regularly to discuss quality controls, goals, or obstacles related to the laboratory.

20%: Supervision of Laboratory Staff

• In collaboration with Executive Director, work with Human Resources to facilitate hiring of all positions in the laboratory.
• Hire, train and supervise Eye Bank Scientist(s) and Laboratory Coordinator(s).
• Supervises laboratory staff, which includes prioritization and assignment of work; manage lab staff schedules and staffing levels; ensure all staff are trained and follow policies and procedures; maintain a healthy and safe working environment; and make hiring, promotional, termination and disciplinary recommendations.
• Meet regularly with staff to provide mentorship, education, guidance and to determine priorities. Provide timely, regular and effective feedback and set performance goals for individual staff members and group. Work with staff to provide opportunities for career growth and learning.
• Facilitate performance evaluations for personnel directly reporting to this position and ensure direct reports perform probationary and annual performance assessments for their staff.
• Ensure development and completion of annual training and competencies for laboratory staff in collaboration with Quality Systems.

As Needed: Other

• Attend national eye banking functions and participate in training on eye donation to outside organizations, e.g., educational institutions, ophthalmology groups, ophthalmology fellows and residents, donation partners; present on behalf of LGS to national organizations and serve on national committees as they relate to eye donation.

The University of Minnesota offers a comprehensive benefits package including:

• Competitive wages, paid holidays, vacation and sick leave
• Low cost medical, dental, and pharmacy plans
• Health care and dependent daycare flexible spending accounts
• Excellent retirement plans with employer match
• Disability and employer paid life insurance
• Wellbeing program with reduced insurance premiums
• Tuition reimbursement opportunities covering 75%-100% of eligible tuition
• Student loan forgiveness opportunity
• Opportunities for growth and promotion
• Employee Assistance Program