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.

Company Overview

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:

Job Description

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
• Ability to interpret technical information and documentation used for operations and production activities
• Experience managing diverse stakeholders with strong interpersonal and influencing skills; effective communicator
• Practical, demonstrable knowledge of cGMP and compliance regulations
• Strong interpersonal skills, including the ability to negotiate and resolve challenges with diplomacy

Job Scope and Impact

• Works on issues requiring conceptual thinking and deep knowledge of organizational objectives; problems may be ambiguous and lack established direction.
• Implements policies and selects methods, techniques, and evaluation criteria to achieve results.
• Drives strategy and success of larger projects that contribute to multiple areas of the organization.
• Decisions carry significant impact on schedules and unit operations and may affect broader business activities; impacts short-term (less than one year) results.
• Interacts regularly with lower and senior management across several functions and with customers; persuades and influences in complex, sensitive situations.
• Manages activities of two or more disciplines or a department; oversees experienced professionals and may manage subordinate managers; advises teams on moderately complex matters.

Reporting Structure

• Approximately 3 direct reports
• Approximately 80 indirect reports

Benefits

• Competitive compensation with potential incentives aligned to site and individual performance
• Comprehensive health and wellness coverage
• Retirement savings plan with employer support
• Generous paid time off and company holidays
• Flexible work scheduling within a 24/7 operational environment, where business needs allow
• Professional development, leadership training, and mentorship opportunities
• Inclusive culture with employee resource groups and recognition programs
• Opportunities to lead high-impact initiatives and shape site-wide processes

We welcome applicants from all backgrounds and experiences. If you're energized by building teams, scaling manufacturing operations, and delivering for patients and customers, we encourage you to apply.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

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.

ADA Information

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]).