Job Description

Job Description

Manufacturing Manager

Department: Manufacturing / Operations

Reports To: Chief Operating Officer / CEO

Direct hire full-time role

Position Summary

The Manufacturing Manager oversees the day-to-day operations of IVD product manufacturing, ensuring production activities are executed safely, efficiently, and in compliance with ISO 13485, FDA 21 CFR Part 820 (QSR), and IVDR requirements. This role is responsible for managing production teams, maintaining product quality, meeting output goals, and supporting continuous process improvements to ensure the reliable supply of high-quality diagnostic products.

Key Responsibilities

• Lead and manage manufacturing operations for IVD products, including reagents, consumables, and diagnostic kits.
• Oversee the end-to-end manufacturing of plastic cartridges, from raw material handling and injection molding to automated assembly, inspection, and packaging.
• Plan, schedule, and coordinate production activities to meet customer demand, quality standards, and on-time delivery targets.
• Ensure compliance with ISO 13485, FDA QSR (21 CFR Part 820), IVDR, GMP, and other applicable regulatory requirements.
• Develop, implement, and monitor manufacturing procedures, batch records, and work instructions.
• Oversee training, development, and performance management of manufacturing staff to ensure competency and compliance.
• Collaborate with Quality Assurance, Quality Control, R&D, and Supply Chain to support new product introduction, technology transfer, and process scale-up.
• Monitor and analyze production metrics (yield, throughput, scrap rate, deviations) to drive operational efficiency and continuous improvement.
• Lead investigations into deviations, nonconformances, and complaints; implement corrective and preventive actions (CAPAs).
• Ensure manufacturing equipment is maintained, calibrated, and qualified per quality system requirements.
• Support audits and inspections by regulatory authorities and notified bodies.
• Drive a culture of safety, compliance, and operational excellence within the manufacturing team.

Qualifications

• Bachelor’s or Master’s degree in Biotechnology, Biology, Chemistry, Engineering, or related life science/technical discipline.
• 5+ years of experience in manufacturing within the IVD, medical device, pharmaceutical, or biotech industry.
• 2+ years in a supervisory or management role.
• Strong understanding of IVD manufacturing processes (e.g., reagent formulation, dispensing, filling, kitting, packaging).
• Demonstrated experience overseeing the manufacturing of molded plastic components, to include knowledge of injection molding, tooling management, polymer material handling, and high-speed automated assembly.
• In-depth knowledge of regulatory and quality standards: ISO 13485, FDA QSR (21 CFR Part 820), IVDR, GMP.
• Proven track record in managing teams, production schedules, and cross-functional projects.
• Excellent organizational, leadership, and problem-solving skills.
• Proficiency with ERP/MRP systems, production scheduling, and manufacturing documentation.

Preferred Skills

• Experience with Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.
• Hands-on experience with technology transfer and scaling of IVD products from R&D to commercial production.
• Knowledge of risk management (ISO 14971) and design transfer processes.
• Strong communication skills with the ability to influence and collaborate across departments.

Working Conditions

• Primarily on-site in a manufacturing and cleanroom environment.
• Requires routine interaction with laboratory chemicals, biological materials, and specialized production equipment.
• Occasional evening or weekend work may be required to support production schedules.

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