Description

The Assay Production Supervisor – Accellix is responsible for coordinating and supervising daily manufacturing activities for the Accellix product line. This role provides day-to-day leadership for manufacturing technicians while serving as the primary technical resource for laboratory-based manufacturing processes including reagent formulation, liquid handling, assay preparation, controlled drying operations, and in-process quality controls.

The supervisor ensures activities are performed safely, efficiently, and in compliance with GMP requirements while achieving production, quality, and delivery objectives. This role works closely with Quality, Engineering, Supply Chain, and Planning and is expected to maintain hands-on familiarity with equipment, processes, and workflows used within the Accellix manufacturing operation.

Key Responsibilities

Production Leadership

• Coordinate daily manufacturing activities to meet safety, quality, delivery, and productivity objectives
• Assign work, monitor progress, and adjust resources to support production priorities
• Support execution of formulation, drying, inspection, and manufacturing operations
• Monitor production schedules and work orders to ensure timely completion of manufacturing activities
• Provide real-time support for production issues and escalate concerns as appropriate

Technical Leadership

• Serve as the primary technical resource for manufacturing technicians during day-to-day operations
• Provide guidance on laboratory-based manufacturing processes including reagent preparation, liquid handling, and assay workflows
• Support troubleshooting of process, equipment, and workflow issues
• Ensure proper use of manufacturing and laboratory equipment
• Reinforce adherence to standard work and process controls

People Leadership

• Supervise, coach, and develop manufacturing technicians
• Support employee onboarding, training, qualification, and cross-training activities
• Provide performance feedback and development support
• Foster a culture of accountability, teamwork, safety, and continuous improvement

Quality & Compliance

• Ensure manufacturing activities are performed in accordance with GMP, GDP, and approved procedures
• Review production documentation for completeness, accuracy, and compliance
• Support deviations, investigations, CAPA activities, and audit readiness
• Reinforce process controls that support product quality, assay performance, and traceability

Continuous Improvement

• Monitor production performance and identify opportunities to improve safety, quality, delivery, and productivity
• Support implementation of process improvements and operational excellence initiatives
• Drive adherence to standard work and operational discipline
• Provide operational input for manufacturing improvements and process changes

Cross-Functional Collaboration

• Partner with Quality Control, Engineering, Maintenance, Supply Chain, and Planning teams
• Ensure alignment between production activities, testing requirements, and business priorities
• Communicate production status, risks, and improvement opportunities to leadership

Supplemental Data

• Day-shift leadership role with substantial floor presence
• Acts as a working supervisor and technical resource for laboratory-based manufacturing operations
• Supports execution and operational performance of the Accellix consumables manufacturing process

Qualifications

Minimum Requirements

• High School Diploma or GED
• 6+ years of experience in biotechnology, diagnostics, pharmaceutical, laboratory, medical device, or other regulated manufacturing environments and working with manufacturing documentation, quality systems, and production metrics
• 2+ years of leadership experience including leading, training, or coordinating technical personnel, laboratory manager, or equivalent responsibilities

Preferred Qualifications and experience

• Associate’s or Bachelor's degree in Biology, Biotechnology, Chemistry, Life Sciences, Engineering, Manufacturing, or related discipline
• GMP, GDP, or laboratory compliance training
• Lean Manufacturing or Six Sigma training
• Experience as a Laboratory Manager, Laboratory Supervisor, QC Lead, Lead Technician, or similar role
• Experience supporting reagent formulation or consumable manufacturing
• Experience with controlled drying, stabilization, or vacuum oven processes
• Experience supporting technology transfer, process startup, or manufacturing scale-up activities
• Experience in diagnostics, cell-based assays, flow cytometry, or laboratory consumables manufacturing

Knowledge, Skills, and Abilities

• Strong understanding of laboratory-based manufacturing processes
• Hands-on experience with liquid handling, reagent preparation, and assay workflows
• Working knowledge of laboratory and manufacturing equipment
• Strong leadership and team development skills
• Effective problem-solving and decision-making capability
• Ability to prioritize work and manage multiple production activities
• Ability to analyze production performance and drive operational improvements
• Working knowledge of GMP, GDP, and quality system requirements

Working Conditions and Physical Requirements

• Combination of production floor and office environment
• Ability to stand and walk for extended periods
• Ability to wear required PPE in manufacturing areas
• Frequent use of laboratory equipment and manufacturing tools
• Occasional lifting and material handling as needed
• Flexibility to support production activities outside normal business hours when required

The estimated wage range for this role based in Illinois is between $31.30 – $45.10. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer. 

In addition, bioMérieux offers a competitive Total Rewards package that may include: 

·        A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options 

·        Company-Provided Life and Accidental Death Insurance 

·        Short and Long-Term Disability Insurance 

·        Retirement Plan including a generous non-discretionary employer contribution and employer match. 

·        Adoption Assistance 

·        Wellness Programs 

·        Employee Assistance Program 

·        Commuter Benefits 

·        Various voluntary benefit offerings 

·        Discount programs 

·        Parental leaves 

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