Head of Manufacturing

About the Role:

Head of Manufacturing - In Vitro Diagnostics (IVD) / Molecular Diagnostics / NGS

Full-Time | Onsite

Overview

We are seeking a seasoned Head of Manufacturing to lead end-to-end manufacturing operations for our In Vitro Diagnostics (IVD) product portfolio, with a strong emphasis on molecular diagnostics and Next-Generation Sequencing (NGS). This onsite leadership role requires deep technical expertise, operationalexcellence, and hands-on oversight to ensure scalable, compliant, and high-quality production of regulated diagnostic products. Experience with regulatory submissions such as 510(k), PMA, and CE Marking, as well as companion diagnostics (CDx)is highly preferred.

The ideal candidate is a strategic, execution-driven leader with extensive background in design controls, process validation, GMP/ISO 13485 compliance, and cross-functional collaboration across R&D, QA/RA, and supply chain teams.

Key Responsibilities:

Manufacturing Leadership & Strategy
• Develop and execute manufacturing strategies that support the growth of the IVD/NGS product portfolio.
• Lead daily production operations, ensuring alignment with organizational goals and delivery timelines.
• Oversee multiple concurrent projects and production streams in a fast-paced, high-growth environment.
• Define and track KPIs, reporting performance and operational updates to senior leadership.


Production Operations & Process Improvement
• Plan, coordinate, and monitor manufacturing schedules to ensure timely, high-quality output.
• Analyze and optimize workflows for efficiency, scalability, and cost-effectiveness.
• Establish and maintain IQ/OQ/PQ validation programs for instruments, equipment, and processes.
• Drive continuous improvement initiatives using RCA, CAPA, and lean methodologies.
• Maintain a strong onsite presence to support troubleshooting, workflow execution, and operational readiness.
• Ensure compliance with GMP, ISO 13485, and applicable IVD regulatory requirements. Quality, Compliance, & Documentation
• Oversee creation and maintenance of DHF, DMR, and DHR documentation.
• Ensure rigorous documentation practices and secure record management.
• Lead and participate in internal and external regulatory and quality audits.
• Partner closely with QA, QC, and Regulatory Affairs to resolve issues, maintain product integrity, and support compliance activities.


Cross-Functional Collaboration
• Collaborate with R&D, Product Development, Supply Chain, and Commercial teams to transition new products into manufacturing.
• Align on resource planning, production schedules, and technical specifications.
• Provide manufacturing input for risk assessments, design transfer, and lifecycle management.

Team Development & Leadership
• Recruit, coach, and develop high-performing manufacturing staff.
• Ensure team training in SOPs, GMP, safety practices, and technical workflows.
• Foster a culture of accountability, collaboration, continuous improvement, and operational excellence.

Qualifications
• Bachelor's or Master's degree in Molecular Biology, Biotechnology, Engineering, or related discipline.

advanced degree preferred.
• 10+ years of experience in IVD, molecular diagnostics, or NGS manufacturing, with 5+ years in a

leadership/management role.
• Strong expertise in GMP operations, design controls, risk management, and regulatory frameworks

(FDA, IVDR, ISO 13485).
• Proven success scaling manufacturing operations and leading technology transfers.
• Demonstrated experience supporting and managing regulatory audits.
• Excellent communication, leadership, and problem-solving skills; ability to thrive in dynamic, high-growth environments

environments.
• Ability to work onsite daily to lead and support manufacturing operations.