While this is intended to be an accurate reflection of the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments).
RTI Surgical is a global, industry-leading private label OEM with expertise in allograft, xenograft, and synthetic-based implants. RTI began operations in 1998 when it spun off from the University of Florida Tissue Bank in 1998 with the goal of expanding the gift of tissue donation by pioneering tissue-based innovations that promote natural healing. Today, through integrated partnerships with customers, RTI develops and delivers restorative solutions to physicians and their patients.
As a Private Label Original Equipment Manufacturer (PLOEM) partner, RTI provides comprehensive turn-key services for development and product life cycle management in support of patients and leading medical technology companies. RTI’s implants are used in multiple surgical applications including dental, spine, sports medicine, plastic & reconstructive surgery, urology/urogynecology, and trauma.
RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on four key values:
We are accountable to each other by trusting each other’s judgment and holding each other responsible for results.
We find joy by striving to create a working environment that people enjoy.
We fully engage by focusing our hearts and minds on our customers, patients, and each other.
We adapt to change by working collaboratively to be flexible to the changing needs of our business.
RTI’s headquarters is located near Gainesville, Fla. in North Central Florida’s growing life sciences region, and has additional state-of-the-art facilities in Greenville, N.C., and Germany.
Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.
The BioMedical Laboratory Supervisor oversees a team of 5-8 BMS Technicians responsible for the execution of Laboratory testing to support manufacturing operations. The supervisor coordinates services, staff, procedures policies and functions of a licensed Clinical Laboratory; hires, trains, supervises and evaluates all testing and/or support personnel; directs and assists other professional staff in making clinical judgments.
The BioMedical Laboratory Supervisor interfaces with Operations personnel, Computer programs, worksheets, human samples, chemicals, reagents, and laboratory equipment. The position requires high level of skills including organization, communication, diligence, and patience.
The BioMedical Laboratory is an environment with cleanliness requirements and Good Lab Practices to be followed. The computer programs are used daily and proficiency with these Laboratory applications is fundamental to the position’s success. Interfacing with Operations personnel (customers) requires good communication to identify and resolve potential issues before they arise. Problem Solving skills and attention to detail is required for addressing issues when they do occur.
Responsible for drafting Documents describing the required policies and procedures for standard work.
Responsible for the dissemination, training and enforcement of policies and procedures.
Maintain laboratory quality control program(s); supervises and monitors the quality of test results through period monitoring and review mechanisms and participation in external proficiency test programs as required by regulatory agencies.
Maintain support programs internally and interface with external support programs; including but not limited to: materials management, equipment maintenance / calibration, and laboratory infrastructure / procedures, and projects.
Laboratory internal operations include, but are not limited to, equipment maintenance / calibration, material management, capacity planning, reagent preparations, cell culture and other supporting operations, environmental monitoring, and laboratory upkeep.
Maintain CLIA Licensure for the BioMedical Laboratory
Supervises and monitors the proper disposal of biohazardous waste generated by the Laboratory, including collection, packaging, labelling, handling and tracking; responsible for documentation in accordance with OSHA standards.
Ensure cGMP and EHS compliance as well as good laboratory housekeeping practices of direct reports.
Responsible for reviewing and revising Laboratory procedures and policies to comply with regulatory requirements, including but not limited to the Occupational Safety and Health Administration (OSHA), the Centers for Disease Control and Prevention (CDC), and the Clinical Laboratory Improvement Amendments (CLIA).
Make recommendations to Manager for additional personnel and equipment resources that might be needed to meet our commitments.
Prepares and processes all necessary paperwork and maintains appropriate records; meets with vendor representatives to discuss and evaluate new equipment and test procedures; prepares specifications; monitors and resolves problems related to purchasing and delivery of supplies and equipment.
Maintain excellent communications with Managers and Team Leads to ensure awareness and collaborate on resolution of any deviations of required performance standards.
Maintaining project timelines and scheduling of testing and requests. Often Requires working with other ancillary departments.
Support efforts driven by R&D and Operations that require BioMedical Laboratory support, collaboration and implementation projects.
Maintain databases to collect metrics on samples processed by R&D, reports sent out, and other critical metrics.
Schedule and coordinate R&D resources using program scheduling and capacity tools.
Conduct regular team meetings to facilitate communication and planning.
Maintain accountability regarding standard work, compliance, and project execution.
Design and supervise progress against the schedules for each Technician ensuring that operations are completed on time.
Supervise the training of all Technicians within the group to ensure that they are fully proficient to conduct the studies assigned to them and that they are provided with a career development plan.
Support, develop and implement departmental continuous improvement initiatives.
Support efforts with the R&D and Ops teams.
Makes recommendations for continued improvements within lab operations.
May perform all duties of BMS Laboratory Technologist.
Performs other related duties as required.
Understand Key Performance Indicators
Identify areas for improvements and engage in problem solving
Models positive thinking and is open to change, motivating the team to adapt to shifts.
Understand and adhere to Good Laboratory Practices
Ensures all OSHA, state, and federal regulatory guidelines are met as related to handling of human samples, shipping of samples to and from the laboratory facility and assisting visitors in the laboratory.
Microsoft Office proficiency
Communication & Teamwork
Critical Thinking & Problem Solving
Ability to make decisions and work with minimal to moderate supervision
Bachelor’s degree in Business, Operations, or Sciences with minimum of 3 years’ experience in Laboratory / Life Sciences role.
Supervisor License for Florida Biomedical Laboratory Clinical Laboratory Improvement Amendments (CLIA) is required.
Possesses a highly developed quality, regulatory and production approach.
Previous supervision and/or leadership and training experience.
Experience in production control, materials, scheduling, and/or manufacturing; SAP, SmartSolve, and IT system experience is a plus.
Project management or Lean Six Sigma training a plus.
Ability to function in a fast paced, multifaceted environment with multiple priorities simultaneously.
Light work: Physically handle objects up to 20 lbs. occasionally.
Laboratory Setting – Zones for various processes, Workbenches, Controlled Environment Areas, Ventilation Hoods, etc.
Office Setting – Open layouts and closed space conference rooms