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.

Shift: Monday-Friday 8:00am-5:00pm

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.
• Work closely with the Supply Chain and Materials Management teams to ensure material availability and inventory accuracy.
• Collaborate with management to plan budgeting and develop forecasting models.
• 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.
• Job duties may vary based on Laboratory location and at supervisory discretion.

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.
• Working knowledge of supply chain and inventory management systems.
• Proven experience in change management.
• Good technical writing and verbal communication skills.

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.

EEO

We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.

#LI-HH1