Associate Director, Drug Product

Position Overview

Lead the launch of a world-class, 24/7 drug product manufacturing operation. As Associate Director, Drug Product Manufacturing, you will build and lead a new organization to achieve GMP readiness, onboard customers, and drive operational excellence across formulation, aseptic filling, wash and sterilization, inspection, and support. If you thrive on creating high-performing teams, shaping culture, and delivering results in a dynamic environment, this role is for you.

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

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:

About Us We are a growing biopharmaceutical manufacturing site committed to quality, safety, and customer success. Our teams work around the clock to deliver life-impacting drug products. You’ll join a global, collaborative environment grounded in strong leadership principles, an End-to-End (E2E) mindset, and a focus on continuous improvement. We value inclusive leadership, clear communication, and accountability—while empowering our people to do their best work.

Responsibilities During Project Phase

• Create, own, and track execution of the Operational Readiness Plan for Drug Product manufacturing, including:
• Developing Standard Operating Procedures (SOPs)
• Building detailed project timelines
• Developing the staffing plan
• Establishing and managing budgets

During Project Phase and in Operations

• Lead, manage, and support area managers, supervisors, and associates, with an emphasis on team, talent, and process development.
• Define and own business processes for Drug Product functions, including Formulation, Aseptic Filling, and Manual/Automated Visual Inspection.
• Provide subject matter expertise on Drug Product Manufacturing for risk assessments (e.g., FMEA, QRA) and operations.
• Champion best practice sharing and continuous improvement across Drug Product operations.
• Provide input and support for robust deviation investigations; own CAPAs and oversee process monitoring.
• Manage departmental budgeting and monitor overall fiscal performance for the functional area.
• Establish, track, and drive KPIs for the Drug Product team to ensure performance to plan.
• Develop, own, and maintain the staffing plan aligned to operational needs and growth.
• Collaborate with other FDB locations and clients to align on commitments and deliverables.
• Evaluate, assess, and develop timelines; communicate clearly to relevant stakeholders.
• Support a 24/7 manufacturing facility; flexibility with working hours may be required.
• Travel up to 0–25% as business needs require.
• Other duties as assigned.

Minimum Education and Experience Requirements

• Bachelor’s Degree
• 7 years of direct Drug Product operations experience
• 10 years in the pharmaceutical industry
• Previous experience leading and developing leaders (Managers / Supervisors)

Preferred Education Requirements

• Bachelor’s degree in STEM
• 10 Years direct Drug Product with hands on experience
• Prior experience in client interface

Knowledge, Skills, and Abilities

• Demonstrated experience in team management and problem solving
• Strong facilitation skills and proven leadership of cross-functional teams
• Proven track record for implementation within established deadlines
• Abi…