Senior Director, Process Development Operations

Fujifilm • Morrisville, NC

22h • Onsite

About The Position

As Senior Director, Process Development Operations at Fujifilm Biotechnologies’ Morrisville, NC site (FLBU), you will lead a powerhouse team, owning end-to-end PD delivery. This involves accelerating tech transfers, elevating technical excellence, and ensuring on-time, on-quality program outcomes that satisfy customers and drive business growth. You will be a member of the site leadership team, contributing to the U.S. PD Center of Excellence and influencing network-wide standards. This highly visible, cross-functional leadership role is ideal for a builder who excels at the intersection of science, execution, and client engagement. FUJIFILM Biotechnologies is dedicated to advancing tomorrow’s medicines, offering life-impacting projects alongside innovative biopharmaceutical companies. The company fosters collaboration, creativity, and purpose within its Bioprocess Innovation Center and cGMP-compliant manufacturing site. Located in Morrisville, NC, within Research Triangle Park (RTP), the site is part of a thriving biotech hub. Fujifilm is a global company headquartered in Tokyo with over 70,000 employees across healthcare, electronics, business innovation, and imaging segments, united by the purpose of “giving our world more smiles.”

Requirements

• 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 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.
• 10+ years’ experience managing, leading and developing people, with 4+ years’ experience leading and developing team leaders.
• Strong experience in implementing process developments and technological improvements within manufacturing environments.
• Comprehensive knowledge of regulatory compliance and industry standards related to tech transfer and manufacturing.

Nice To Haves

• Ph.D. in Engineering, Biotechnology, Chemistry, Pharmaceutical Science, or related field is preferred.
• Proven track record of managing complex technology transfer projects and digital manufacturing optimization on a global scale.
• Strong understanding of scaling processes from development to large-scale production.
• Customer-facing experience to partner with and support the commercial sales team.

Responsibilities

• Serve as executive sponsor for key programs—from kick-off to closeout—aligning teams, managing milestones, proactively mitigating risk, and ensuring transparent client communication.
• Make tech transfer speed and quality a competitive advantage—standardize, integrate, and optimize new facilities, platforms, and practices across PD.
• Drive operational excellence across Upstream, Downstream, Analytical Development, integrated AD/QC labs, MSAT, and the clinical cGMP manufacturing interface.
• 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.
• Lead and develop senior leaders and their teams; foster a culture of collaboration, innovation, and continuous improvement with psychological safety and high accountability.
• 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.
• Own PD operating performance—capacity planning, resource allocation, fixed cost control, and operating budget—with measurable impact on revenue, margin, and site utilization.
• Champion harmonization across global sites; standardize methods, documentation, and digital tools (e.g., MES/LIMS/eQMS/ERP integrations).
• Ensure audit-ready compliance with cGMP, GLP/GDocP, data integrity/ALCOA+, and quality systems; support inspections, due diligence, and high-stakes client forums.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 501-1,000 employees