Head of Manufacturing

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    "requisitionDescription": "<div><div><div><div><article tabindex=\"-1\" dir=\"auto\" data-turn-id=\"8361f515-1b63-4fc2-8624-3e50e14f0b89\" data-testid=\"conversation-turn-11\" data-scroll-anchor=\"false\" data-turn=\"user\" data-pasted=\"true\"><div tabindex=\"-1\"><div data-message-author-role=\"user\" data-message-id=\"8361f515-1b63-4fc2-8624-3e50e14f0b89\" dir=\"auto\"><div data-multiline=\"\"><strong>About the Role: </strong><br><br></div><p data-pasted=\"true\">Head of Manufacturing &ndash; In Vitro Diagnostics (IVD) / Molecular Diagnostics / NGS</p><p>Full-Time | Onsite</p><p>Overview</p><p>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.</p><p>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&amp;D, QA/RA, and supply chain teams.</p></div></div></article><article tabindex=\"-1\" dir=\"auto\" data-turn-id=\"696cbba8-9ac1-4e4b-a485-838af49a9227\" data-testid=\"conversation-turn-12\" data-scroll-anchor=\"true\" data-turn=\"assistant\"><div tabindex=\"-1\"><div data-message-author-role=\"assistant\" data-message-id=\"107ddb8b-0ee4-4f1c-9976-78bdc5dfc388\" dir=\"auto\" data-message-model-slug=\"gpt-5-2\"><p data-start=\"0\" data-end=\"340\"><br></p><p data-pasted=\"true\"><strong>Key Responsibilities:</strong></p><p><strong>Manufacturing Leadership &amp; Strategy</strong></p><p>&bull; Develop and execute manufacturing strategies that support the growth of the IVD/NGS product portfolio.</p><p>&bull; Lead daily production operations, ensuring alignment with organizational goals and delivery timelines.</p><p>&bull; Oversee multiple concurrent projects and production streams in a fast-paced, high-growth environment.</p><p>&bull; Define and track KPIs, reporting performance and operational updates to senior leadership.&nbsp;</p><p><strong>Production Operations &amp; Process Improvement</strong></p><p>&bull; Plan, coordinate, and monitor manufacturing schedules to ensure timely, high-quality output.</p><p>&bull; Analyze and optimize workflows for efficiency, scalability, and cost-effectiveness.</p><p>&bull; Establish and maintain IQ/OQ/PQ validation programs for instruments, equipment, and processes.</p><p>&bull; Drive continuous improvement initiatives using RCA, CAPA, and lean methodologies.</p><p>&bull; Maintain a strong onsite presence to support troubleshooting, workflow execution, and operational readiness.</p><p>&bull; Ensure compliance with GMP, ISO 13485, and applicable IVD regulatory requirements. Quality, Compliance, &amp; Documentation</p><p>&bull; Oversee creation and maintenance of DHF, DMR, and DHR documentation.</p><p>&bull; Ensure rigorous documentation practices and secure record management.</p><p>&bull; Lead and participate in internal and external regulatory and quality audits.</p><p>&bull; Partner closely with QA, QC, and Regulatory Affairs to resolve issues, maintain product integrity, and support compliance activities.&nbsp;</p><p><strong>Cross-Functional Collaboration</strong></p><p>&bull; Collaborate with R&amp;D, Product Development, Supply Chain, and Commercial teams to transition new products into manufacturing.</p><p>&bull; Align on resource planning, production schedules, and technical specifications.</p><p>&bull; Provide manufacturing input for risk assessments, design transfer, and lifecycle management.</p><p><strong>Team Development &amp; Leadership</strong></p><p>&bull; Recruit, coach, and develop high-performing manufacturing staff.</p><p>&bull; Ensure team training in SOPs, GMP, safety practices, and technical workflows.</p><p>&bull; Foster a culture of accountability, collaboration, continuous improvement, and operational excellence.<br><br></p><p><strong>Qualifications</strong></p><p>&bull; Bachelor&rsquo;s or Master&rsquo;s degree in Molecular Biology, Biotechnology, Engineering, or related discipline.</p><p>advanced degree preferred.</p><p>&bull; 10+ years of experience in IVD, molecular diagnostics, or NGS manufacturing, with 5+ years in a</p><p>leadership/management role.</p><p>&bull; Strong expertise in GMP operations, design controls, risk management, and regulatory frameworks</p><p>(FDA, IVDR, ISO 13485).</p><p>&bull; Proven success scaling manufacturing operations and leading technology transfers.</p><p>&bull; Demonstrated experience supporting and managing regulatory audits.</p><p>&bull; Excellent communication, leadership, and problem-solving skills; ability to thrive in dynamic, high-growth environments</p><p>environments.</p><p>&bull; Ability to work onsite daily to lead and support manufacturing operations.</p></div></div></article><form data-type=\"unified-composer\"><div contenteditable=\"true\" translate=\"no\" data-virtualkeyboard=\"true\"><br></div></form></div></div></div></div>\n",
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