Manufacturing Laboratory Supervisor - Assay

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.

• 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 elevate concerns as appropriate

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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…