Reagent Manufacturing Manager

Overview

The Manager Reagent Manufacturing is responsible for leading day-to-day reagent manufacturing operations to ensure safe, compliant, and efficient production that meets quality, cost, and delivery objectives. This role manages production teams and workflows, executes manufacturing plans, and ensures adherence to established processes, quality systems, and regulatory requirements. The Manager Reagent Manufacturing partners closely with Laboratory Operations, Supply Chain, Process Engineering, and Quality leadership to support production targets, resolve issues, and drive continuous improvement.

Responsibilities

• Manage daily reagent manufacturing operations, including production scheduling, staffing, and workflow execution.
• Ensure manufacturing activities meet quality, yield, cycle time, and delivery targets.
• Monitor production performance and proactively address issues affecting output, quality, or safety.
• Serve as first-line escalation point for production deviations, equipment issues, and material constraints.
• Track and report manufacturing KPIs; escalate trends or risks as appropriate.
• Communicate production status, risks, and performance to leadership and stakeholders.
• Lead, coach, and develop manufacturing supervisors and frontline production staff.
• Support employee training, onboarding, qualification, and performance management.
• Enforce adherence to SOPs, work instructions, and good documentation practices.
• Ensure compliance with FDA, CLIA, CAP, ISO, OSHA, and internal quality system requirements.
• Partner with Quality to support deviation investigations, CAPAs, change control, and audit readiness.
• Collaborate with Supply Chain and Materials Management teams to ensure material availability and inventory accuracy.
• Collaborate with enterprise teams (R&D, Process Engineering, Lab Operations,…) on technology transfer, scale-up and sustaining activities.
• Lead or participate in Lean, Six Sigma, or continuous improvement initiatives aimed at improving efficiency, quality and cost.
• Execute approved process changes, manufacturing improvements, and standard work updates.

Qualifications and Skills

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related technical field preferred, or an equivalent combination of education and relevant manufacturing experience.
• Minimum of 5 years of experience in reagent manufacturing in a diagnostic or quality-regulated manufacturing environment, including at least 2 years in a supervisory or people leadership role.
• Experience working in an FDA-regulated or similarly regulated manufacturing environment (CLIA, CAP, NYSDOH, ISO).
• Strong knowledge of GMPs, quality systems, and compliant manufacturing practices.
• Strong frontline leadership and team management skills.
• Demonstrated ability to manage shifting priorities and solve production problems in real time.
• Experience with automated manufacturing platforms, including operation, troubleshooting, and scale-up in a production setting.
• Proficiency with manufacturing KPIs and basic data analysis.
• Advanced knowledge of materials forecasting and budgeting processes.
• Proven experience in change management.
• Good technical writing and verbal communication skills.

About Us

For more than 30 years, Myriad Genetics has led the way in precision medicine by delivering important insights to help people make informed health decisions. As a leading molecular diagnostic testing and precision medicine company, we are dedicated to advancing health and well-being for all. Our innovative genetic tests are used across specialties including oncology, women’s health, and mental health, empowering clinicians to personalize treatment and help their patients take proactive steps toward better outcomes.

Physical Requirements

• Lifting Requirements – light work or exerting up to 20 pounds of force frequently.
• Physical Requirements – stationary positioning, moving, operating, ascending/descending, communicating, and observing.
• Use of equipment and tools necessary to perform essential job functions.