Head of Manufacturing

Predicine, Inc•Hayward, CA

2d•Onsite

About The Position

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.

Requirements

Bachelor’s or Master’s degree in Molecular Biology, Biotechnology, Engineering, or related discipline.
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.

Nice To Haves

advanced degree preferred.
Experience with regulatory submissions such as 510(k), PMA, and CE Marking, as well as companion diagnostics (CDx)is highly preferred.

Responsibilities

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.
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.
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.
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.