Production Manager (2nd Shift)

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As a Production Manager, Reagent Filling & Packaging, and you will lead manufacturing operations that ensure the safe, efficient, and compliant production of medical device reagents while achieving quality, delivery, and cost objectives.

This role is responsible for driving operational excellence, developing high-performing teams, and supporting business growth through continuous improvement and execution of production plans.
This role reports to the Director of Operation.

The position plays a key role in ensuring product availability, regulatory compliance, employee engagement, and operational performance in a regulated medical device manufacturing environment.

Your Role


* You will lead daily reagent filling or packaging operations to achieve safety, quality, delivery, and productivity targets.


* You will develop and coach production operators, fostering a culture of accountability, engagement, and continuous improvement.


* You will drive operational excellence initiatives through Lean Manufacturing, 5S, Standardized Work, and performance management practices.


* You will ensure compliance with FDA, ISO, GMP, EHS, and company quality system requirements.


* You will partner with Supply Chain, Manufacturing, Quality, Engineering, R&D, Maintenance, and Warehouse teams to execute production plans and resolve operational challenges.


* You will manage department resources, capacity, and continuous improvement projects to support business growth and customer demand.

Required Qualifications

Experience: Minimum 6 years of manufacturing leadership experience in medical device, diagnostics, pharmaceutical, biotechnology, or other regulated manufacturing environments, including experience leading a production team.

Skills: Strong leadership, production planning, problem-solving, continuous improvement, performance management, and regulatory compliance knowledge; experience with GMP and quality systems.

Education / Certification: Bachelor's degree in Engineering, Life Sciences, Manufacturing, Business, or a related field.

Your Expertise



* Medical device, diagnostics, pharmaceutical, or other regulated manufacturing experience.


* Knowledge of FDA regulations, ISO, GMP, and quality management systems.


* Experience managing filling, packaging, assembly, or related manufacturing operations.


* Proven ability to lead and develop a production team.


* Strong understanding of Lean Manufacturing, 5S, Standardized Work, and continuous improvement methodologies.


* Experience investigating deviations, nonconformance, and implementi...