Meridian Bioscience

Manufacturing Supervisor

Job Locations US-FL-Boca Raton
Company
Meridian Life Science, Inc.
Department
Research and Development
# of Openings
1

About Meridian

 Meridian Bioscience is a first-choice solution provider of innovative immunological and molecular raw materials that accelerate discovery and diagnostic assay development. 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, novel solutions to tough problems.

Job Summary

Position Purpose:

The Manufacturing Supervisor is responsible for managing ascites manufacturing schedules, processes, and resources. The role will oversee upstream antibody manufacturing processes including animal husbandry, animal inventory, and ascites manufacturing unit operations.  The supervisor will be responsible for supporting career development of staff through training and providing performance feedback. The position will assist with the monitoring, trending, and continuous improvement of critical process and performance parameters. The role will work to maintain adherence to schedule and maintenance of product quality through direction of team leads, activity scheduling, overtime scheduling, and resource allocation. The candidate must be able to execute responsibilities in a fast-paced and result-oriented environment satisfying quality standards in accordance with customer satisfaction, cost, schedule, and quality regulations.

 

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Key Duties

Relationships:

  • Key Stakeholders
    • This position will interact with their direct supervisor daily and the director or VP of manufacturing as required. This position will interact with all manufacturing staff, quality assurance staff, quality control staff, technical quality staff, sales staff, finance, procurement, and materials management staff.
    • This position will primarily interact with internal contacts with some customer interaction. This position will organize routine meetings to discuss all information related to the production schedules, conflicts, and complaints. At these meetings both the issue and solutions will be discussed.
  • Line Management
    • This position reports to the Manager of Manufacturing or above.
    • This position will supervise and manage employees.
    • The direct reports for this position will be team leads.

 

Responsibilities Include:

  • Direct management of team leads with responsibility of ascites order fulfillment, adherence to manufacturing deliverables, monitoring product quality, attainment of department goals, and assistance with department budget.
  • Manages and develops the performance of direct reports by setting clear measurable goals, providing timely performance feedback, ensuring appropriate training, leading goal achievement, and supporting career development.
  • Manage and troubleshoot all ascites manufacturing unit operations including animal husbandry and animal inventory processes.
  • Actively participate in production planning and responsible for ascites scheduling ensuring system data integrity for manufacturing data elements including bills of material, routing, capacity, and lead times. Work to minimize manufacturing variances.
  • Collect and analyze personnel productivity and quality metrics for ascites production and organize monthly report for review with management. Use metrics to identify and implement continuous improvement action items.
  • Identify, negotiate, and resolve or escalate conflicts with respect to resource availability, equipment failures, capacity issues, or product quality specifications.
  • Provide hands-on assistance as needed for all manufacturing activities including animal husbandry, priming of mice, inoculation of mice, or ascites collection.
  • Assist with the monitoring, trending, and continuous improvement of critical process parameters through the routine review and management of department KPIs for productivity, efficiency, and quality.
  • Assist with internal and external audits, respond to audit observations, and collaborate on root cause analysis, deviations, CAPAs and process improvements.
  • Perform routine SOP and batch record reviews correcting any errors or omissions.
  • Maintain a safe working environment and report incidents/accidents to site leadership. Ensure all employees work safely with biohazards, chemicals, and hazardous materials.
  • Work with Team Leads to prioritize daily manufacturing schedules and ensure compliance with all applicable ISO13485 regulations and QSRs with strict accordance with company SOPs.
  • Assist with support and guidance for schedule and deliverable commercial and technical questions.
  • Other duties as assigned.

Qualifications

Knowledge, Skills and Abilities:

  • Exhibits sufficient technical knowledge and experience related hybridoma cell culture, animal husbandry, ascites manufacturing, or antibody upstream processing.
  • Previous experience leading or supervising manufacturing within a quality regulated environment.
  • Ability to hire, train, provide both direct and indirect supervision, and provide development opportunities for staff required.
  • Experience in troubleshooting, investigating, and root cause analysis in an ISO or GMP environment.
  • Strong leadership and emotional intelligence to drive the Meridian leadership attributes: Customer Focus, Communication, Accountability, and Results Driven.
  • Team player, allows others to impact decisions, communicate with cross-functional leads.
  • Strong organizational skills, able to impact change and drive it.
  • Ability to make sound leadership and technical decisions that have an impact on business unit achievement.
  • Proficient in technical writing, concise and accurate oral and written reporting of technical data.
  • Ability to translate departmental goals into executable plans understanding technical risks, mitigations, and alternatives.
  • Strong computer proficiency in Microsoft Office, advanced Excel expertise preferred.
  • Ability to read, understand, and follow all company standard operating procedures (SOPs) and guidelines to ensure staff compliance.
  • Readily adapts to changing priorities, effectively manages own time, and sets priorities for direct reports to ensure tasks and projects are completed on time.

 

Education and Experience:

  • Minimal: High school diploma or equivalent with 10+ years of direct experience performing ascites manufacturing or equivalent production processes.
  • Preferred: College degree from an accredited institution in a relevant scientific discipline with 8+ years of relevant manufacturing or research experience in a quality regulated environment.
  • Previous 2+ years of experience as a manufacturing Lead or equivalent management position in a relevant industry.
  • Laboratory Animal Technician (LAT) certification from AALAS or 5+ years of mouse handing experience welcomed.
  • Knowledge of continuous improvements including 5S and Lean systems preferred.

 

Requirements (Physical, Mental and Environmental Demands):

  • Primary work requirements include working in a regulated bioprocessing setting.
  • Must be able to routinely lift 40 lbs. during the work shift.
  • Must be able to wear personal protective equipment (face coverings, gloves, lab coats, etc.)
  • Ability to stand and sit for long periods of time, stoop, reach, push and pull carts throughout the course of the work shift.
  • Ability to concentrate, analyse, and solve complex issues throughout the day.
  • May be required to work outside of normal business hours including evenings and/or weekends to support business needs.
  • Must be able to adhere to applicable biosafety and chemical hygiene practices when on the manufacturing floor or in laboratories.

 We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

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