Head of Process Development Operations

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    "datePosted": "2026-06-08T04:00:00.000Z",
    "description": "<h2>Position Overview</h2>\n<p>Lead a powerhouse team at the heart of Fujifilm Biotechnologies’ growth. As Head of Process Development Operations, you will own end-to-end PD delivery at our Morrisville, NC site (FLBU)—accelerating tech transfers, elevating technical excellence, and ensuring on-time, on-quality program outcomes that delight customers and fuel the business. You’ll sit on the site leadership team, helping to shape the U.S. PD Center of Excellence and influencing standards across our network.</p>\n<p> </p>\n<p>This is a highly visible, cross-functional leadership role for a builder who thrives at the intersection of science, execution, and client engagement.</p>\n<h2>Company Overview</h2>\n<p>At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.</p> \n<p>From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.</p> \n<p>Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.</p> \n<p>Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers</p>\n<h2>Job Description</h2>\n<h2>What you’ll do</h2>\n<ul>\n <li>Serve as executive sponsor for key programs—from kick-off to closeout—aligning teams, managing milestones, proactively mitigating risk, and ensuring transparent client communication.</li>\n <li>Make tech transfer speed and quality a competitive advantage—standardize, integrate, and optimize new facilities, platforms, and practices across PD.</li>\n <li>Drive operational excellence across Upstream, Downstream, Analytical Development, integrated AD/QC labs, MSAT, and the clinical cGMP manufacturing interface.</li>\n <li>Set clear goals and performance indicators; track progress, recognize achievements, and rapidly address gaps to deliver on time, within budget, and to the highest quality standards.</li>\n <li>Lead and develop senior leaders and their teams; foster a culture of collaboration, innovation, and continuous improvement with psychological safety and high accountability.</li>\n <li>Orchestrate cross-functional decisions with Program Management, QA/QC, Manufacturing, Engineering, Supply Chain, Finance, EHS, HR, IT/Digital, and Commercial to meet customer and business outcomes.</li>\n <li>Own PD operating performance—capacity planning, resource allocation, fixed cost control, and operating budget—with measurable impact on revenue, margin, and site utilization.</li>\n <li>Champion harmonization across global sites; standardize methods, documentation, and digital tools (e.g., MES/LIMS/eQMS/ERP integrations).</li>\n <li>Ensure audit-ready compliance with cGMP, GLP/GDocP, data integrity/ALCOA+, and quality systems; support inspections, due diligence, and high-stakes client forums.</li>\n</ul>\n<h2>Why this role matters</h2>\n<ul>\n <li>You will convert strategy into execution that enables clinical supply, accelerates commercial handover, and strengthens customer trust.</li>\n <li>Your leadership sets the bar for cycle time, right-first-time, and cost-to-serve—driving competitive advantage for FLBU and the broader Fujifilm Biotechnologies network.</li>\n <li>Your voice shapes network standards and investment priorities, with direct influence on outcomes that matter to patients and partners.</li>\n</ul>\n<h2>What you’ll bring (minimum requirements — must have)</h2>\n<ul>\n <li>Bachelor’s degree in Engineering, Biotechnology, Chemistry, Pharmaceutical Science, or related field is required with 12+ years of experience in the pharmaceutical, biotechnology, or CDMO industry, with significant expertise in technology transfer and scaling processes; or</li>\n <li>Master’s degree in Engineering, Biotechnology, Chemistry, Pharmaceutical Science, or related field is required with 8+ years of experience in the pharmaceutical, biotechnology, or CDMO industry, with significant expertise in technology transfer and scaling processes</li>\n <li>Ph.D. in Engineering, Biotechnology, Chemistry, Pharmaceutical Science, or related field is preferred.</li>\n <li>10+ years’ experience managing, leading and developing people, with 4+ years’ experience leading and developing team leaders.</li>\n <li>Strong experience in implementing process developments and technological improvements within manufacturing environments.</li>\n <li>Comprehensive knowledge of regulatory compliance and industry standards related to tech transfer and manufacturing.</li>\n</ul>\n<h2>Preferred qualifications</h2>\n<ul>\n <li>Proven track record of managing complex technology transfer projects and digital manufacturing optimization on a global scale.</li>\n <li>Strong understanding of scaling processes from development to large-scale production.</li>\n <li>Customer-facing experience to partner with and support the commercial sales team.</li>\n</ul>\n<h2>Work arrangement</h2>\n<ul>\n <li>This position is on-site 5 days a week at the Morrisville, NC facility in Research Triangle Park.</li>\n</ul>\n<h2>What success looks like</h2>\n<ul>\n <li>On-time, on-quality program delivery with outstanding customer satisfaction.</li>\n <li>Tech transfer velocity and quality become signature strengths of FLBU.</li>\n <li>High-performing teams with clear standards, empowered leaders, and consistent execution.</li>\n <li>Audit readiness and digital enablement that improve speed, reliability, and transparency.</li>\n</ul>\n<h2>Why join us?</h2>\n<ul>\n <li>Impact at scale: Your leadership accelerates life-changing therapies to patients.</li>\n <li>Visibility and influence: Operate at site and global levels with real ownership and accountability.</li>\n <li>Collaborative culture: Partner with world-class experts across PD, QA/QC, Manufacturing, and Commercial in a mission-driven environment.</li>\n</ul>\n<h2>EEO Information</h2>\n<p>Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.</p>\n<h2>ADA Information</h2>\n<p>If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).</p>",
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