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 these areas are operating smoothly and in compliance with eye banking regulations. The Director of Laboratory Operations manages all Eye Bank Scientists and Laboratory Coordinator(s). This position regularly collaborates with the Distribution and Quality Systems departments.
This position is responsible to maintain the LGS Technical Policies and Procedures relating to tissue suitability and processing and ensures that they are up-to-date regarding regulations and processes.
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.
70%: Oversee All Laboratory Operations
Subject matter expert on transplant tissue suitability determination and tissue processing.
Track directives and 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 and collaborate with other eye banks and develop or supervise the development of methods, techniques, instrumentation, and devices to carry out the projects.
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 Tissue 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.
As needed, serve as backup for all Eye Bank Scientist and Laboratory Coordinator Duties.
20%: Regulatory Compliance and Quality Systems
Ensure that Lions Gift of Sight (LGS) is compliant with all Federal Drug Administration (FDA) and Eye Bank Association of America (EBAA) regulations and guidelines related to tissue suitability and processing.
Review LGS technical manual policies and procedures (P&P) relating to tissue suitability and processing at least annually or more frequently as needed and ensure these P&Ps are accurate and in compliance with FDA and EBAA regulations.
Revise, originate or obsolete P&Ps and forms as needed and delegate first draft of policies to appropriate subject matter experts, as needed.
Follow document control process: propose and revise policies, procedures, or revisions for approval by Quality Systems and signature by Executive Director and Medical Director.
Ensure training is provided to appropriate personnel for all changes in P&Ps prior to implementation.
Ensure Executive Director and Medical Directors have access to up-to-date P&Ps.
Review LGS donor records regularly and document findings and discuss with Quality Systems and collaborate on the 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), as assigned and assist Quality Systems with Quality Control Reports as requested and collaborate with Quality Systems regularly to discuss status of the Quality Systems Program (goals or obstacles).
Work with Human Resources, in collaboration with Executive Director to facilitate hiring of all positions in laboratory.
Hire, train, and supervise Eye Bank Scientist(s) and Laboratory Coordinator(s).
Facilitate performance assessments for personnel directly reporting to this position and ensure direct reports perform probationary and annual performance assessments for their staff and review goals regularly with all direct reports.
Ensure development and completion of annual training and competencies for laboratory staff in collaboration with Quality Systems coordinator.
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; give presentations on behalf of LGS to national organizations and serve on national committees.
Bachelor’s or advanced degree with at least six (6) years of experience in organ, tissue, or eye donation or in a healthcare related field.
Supervisory or leadership experience.
Experience in surgical skills maintaining aseptic technique.
Experience working with microscopes.
Clear and concise verbal and written communication skills.
Experience prioritizing multiple tasks successfully with varying/simultaneous deadlines.
Documented experience with critical thinking and decision-making and problem-solving skills.
Demonstrated fine motor skills.
Ability to follow safety guidelines in a human tissue laboratory.
Proficiency using a computer and word processing, spreadsheet and presentation software.
Ability to represent Lions Gift of Sight in a public environment.
Ability and willingness to work varying shifts as outlined below.
Surgical assistant experience.
Previous laboratory surgical skills.
Detailed knowledge of databases, spreadsheets and statistics.
Experience working with human or animal tissue.
Experience working with Food and Drug Administration laboratory regulations.
Knowledge of general disease processes including signs and symptoms.
Additional Salary Information: DOE
Internal Number: 337492
About Lions Gift of Sight/University of Minnesota
Lions Gift of Sight is a full-service eye bank that obtains, medically evaluates, and distributes donor eyes for cornea transplants, research, and education. By providing more than 1,000 corneas for transplant and 1,000 eyes for research every year, the eye bank helps ensure that as many people as possible receive the gift of sight.
Part of the Department of Ophthalmology and Visual Neurosciences, Lions Gift of Sight has restored sight for sixty years.