Head of Manufacturing

Head Of Manufacturing – In Vitro Diagnostics (IVD) / Molecular Diagnostics / NGS

Full-Time | Onsite

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, operational excellence, 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.

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