Job Description

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Provides leadership and is responsible for planning, coordinating, scheduling and managing technical production activities associated with Sensor Assembly, Kit Assembly and Analyzer Assembly manufacturing departments ensuring all operations are conducted within our Quality System.

Key Duties

• Has direct supervisory authority over the entire Sensor Assembly, Kit Assembly and Analyzer Assembly area personnel.
• Assists Senior Management in developing short- and long-term goals and objectives. Provides suggestions and recommendations.
• Plans, prepares, issues, and controls production schedules and directs material requirements to ensure a controlled flow of raw materials timed to meet production requirements.
• Creates weekly production schedules for internal work centers.
• Analyze daily capacity constraints and effect necessary adjustments to resources.
• Monitor actual production and compare to schedule.
• Work with production and quality personnel to resolve on hold or potential scrap inventory issues in a timely manner.
• Provides direction and daily communication on certain production issues.
• Is a key member of the leadership team at the site and will participate/attend key planning meetings and regular updates to develop and execute the roadmap for the site.
• Participates in development of policies and procedures to ensure that they support and complement company-wide strategic objectives.
• Conducts periodic reviews of existing policies and procedures to ensure effectiveness. Ensures that policies and procedures are updated in accordance with evolving production and quality standards.
• Assists Senior Management with startup and integration of new products.
• Coordinates with planning and related departments to determine production schedules and to ensure that product is available and meets customer needs.
• Assists with investigations and root causing problems and product inconsistencies.
• Ensures that production functions are completed in accordance with established GMP, production, safety and quality standards.
• Works closely with Purchasing and Quality Control departments to maintain schedules and meet deadlines.
• Provides assistance and support to related departments as required.
• Keeps management informed of area activities and significant concerns.
• Ensures work areas and equipment are clean, safe and well maintained.
• Coordinates and directs continuous improvement initiatives for all manufacturing areas, leveraging lean tools and methodologies.
• Assists in developing an approach to understanding total cost of quality and ensures action items are developed to reduce such costs.
• Ensures site production targets are met or exceeded to ensure liquidation targets are met consistently.
• Works concurrently with Quality and Process Engineers to increase efficiencies and reduce cost of quality.
• Other duties as assigned.
• Travel: 10%

Qualifications

• Bachelor of Science (BS) degree is highly desirable, high school diploma or general education degree (GED) is required.
• Strong knowledge and work experience in an FDA regulated environment.
• Experience in scientific/manufacturing principles associated with product design, development and manufacture in GLP and GMP environments is required.
• A minimum of five years of supervisory experience is required.
• Experience operating and troubleshooting packaging and/or manufacturing machinery is required
• Experienced in GDP (Good Documentation Practices
• Demonstrated strong leadership, team building and organizational skills.
• Strong attention to detail.
• Ability to analyze processes for compliance, determine and communicate vulnerabilities.
• Strong problem-solving ability.
• Ability to read, understand and follow all company SOPs and guidelines and ensures compliance in direct reports.
• Must possess exceptional communication, interpersonal, problem solving and customer service skills.
• Ability to maintain regular attendance and punctuality requirements.
• May be required to work additional hours outside of the normal work shift to ensure departmental goals are met (evenings and weekends).