Luminex, a DiaSorin Company is seeking dedicated and talented individuals with a proactive and positive ‘can-do’ attitude to join our team. If changing the diagnostic landscape and revolutionizing patient care sounds like something you would like to be a part of, we invite you to apply today! Together, we can help healthcare providers improve patient outcomes, make a difference in fighting the COVID-19 outbreak, and tackle the world’s most pressing health issues. You can learn more about our values, mission, and vision by visiting our website https://www.luminexcorp.com/about-luminex/.
A Brief Overview
Manages associated Manufacturing staff of moderate to high span of control and/or skill level. Leadership position that provides direct oversight to the Reagent Manufacturing area. Responsible for ensuring facilities, resources and equipment are in place to deliver product to the business plan. Includes adherence to all cGMP requirements for the manufacture of In-Vitro Diagnostic products as well as the implementation and execution against operational metrics. Supports and Delivers requirements for new product transfer and integration with new process development, validations and material supply to development teams. Manufacturing environment is a high complexity, small/large run production environment. Responsible for standard and custom Luminex reagent product lines manufactured in and environment that is ISO certified and includes products that are FDA regulated.
What you will do
- Oversee direction, planning, and execution of site reagent manufacturing operations and associated personnel.
- Establish, manage, and report key performance indicators.
- Deliver reagent manufacturing requirements and attainment of production schedule across all standard and custom product lines to ensure that on-time delivery goals are met.
- Interface with the planning organization to set daily reagent manufacturing priorities and optimal utilization of resources.
- Drive fulfillment of reagent manufacturing design transfer responsibilities for new and changed product through validation and market release phases.
- Manage Reagent labor routings and lead times for on-market products for optimal accuracy; facilitate definition of labor routings and lead times for new product introductions.
- Drive efficiency, cost reduction, and quality improvement projects within scope of department.
- Drive or assist in planning, prioritization, development, and implementation of new local and multi-department improvement initiatives, policies, and programs.
- Facilitate design and development of new process capabilities.
- Drive planning and execution for basic validations related to operation specific equipment and processes; support Process Engineering validations for advanced equipment and processes.
- Participate on non-operations project teams as department representative. Lead or participate in effective planning and delivery of global business process introduction, improvement, and harmonization initiatives within scope of Global Manufacturing and Quality.
- Establish and maintain appropriate departmental role-specific training plans; ensure that each team member is properly trained on systems, processes and equipment.
- Monitor and appraise personnel performance; develop and advance personnel consistent with needs of organization.
- Guide selection and procurement and validation of non-recurring material/equipment requirements; generate proposals for capital equipment.
- Investigate complaints and non-conformances. Develop and implement corrective and preventive actions.
- Perform Change Control Board responsibilities for Manufacturing; monitor and review document, manufacturer, and engineering change releases related to Reagent Operation.
- Drive basic departmental document change control and engineering change control activities.
- Oversee operation specific calibration and maintenance of manufacturing equipment and infrastructure including cleanrooms, purified water system distribution, and automation assets.
- Drive annual departmental capital, headcount, and expense budgeting requirements.
- Ensure operational adherence to safety, hazardous waste disposal, and gowning requirements.
- Other duties as assigned.
Education Qualifications
- Associate's Degree Field of chemistry, biological sciences or related field with 10 years of relevant experience in a manufacturing environment in an FDA regulated industry and/or ISO certified organization required or
- Bachelor's Degree Field of chemistry, biological sciences or related field with 8 years of relevant experience in a manufacturing environment in an FDA regulated industry and/or ISO certified organization preferred
Experience Qualifications
- 3+ Years Relevant Manufacturing Operations Leadership preferred
Standard Working Conditions
- Standing - Occasionally
- Stooping - Occasionally
- Bending - Occasionally
- Climbing - Occasionally
- Sitting - Occasionally
- Kneeling - Occasionally
- Lifting of at least 40lbs - Occasionally
Travel Requirements
Luminex Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability status of an otherwise qualified individual, citizenship status, membership or application for membership in a uniformed service, or any other protected characteristic or category protected by applicable law.
Job Type: Full-time