Associate Manager, Downstream Digital Operations

Position Overview

The Associate Manager, Downstream Digital Operations oversees the management and optimization of digital tools such as Manufacturing Execution Systems (MES), data historians, and e-logbooks within Drug Substance Manufacturing. This role involves strategic configuration, approval, and support of recipe-driven operations across one family unit operations (e.g., Upstream, Downstream, or Solutions). The Associate Manager, Digital Operations drives continuous improvement of digital solutions by ensuring alignment with manufacturing processes, integration standards, and stringent regulatory requirements. The Associate Manager, Digital Operations plays a crucial role in the tech transfer process, identifying platform capability gaps to meet new client needs. This role collaborates extensively with cross-functional teams to facilitate seamless digital integration and operational excellence with a focus on promoting digital innovation and enhancing data integrity.

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

What You'll Do

• Manages and develops the Digital Operations team for either Upstream, Downstream or Solution unit operations, providing guidance and ensuring effective performance management
• Oversees the selection, deployment, integration, and maintenance of digital tools (e.g., MES, data historians, e-logbooks)
• Leads the identification and implementation of solutions to address capability gaps in digital operations, ensuring alignment with new product and client requirements within the RDO process
• Establishes clear objectives and expectations, conducting performance evaluations for team members
• Oversees configuration and approval, ensuring alignment with manufacturing requirements and regulatory standards
• Manages support activities for digital operations systems, maintaining consistency and reliability
• Owns the development and delivery of training sessions and platforms for the Digital Operations team and other functional stakeholders
• Identifies and implements solutions areas for process enhancement and efficiency within recipe-driven automation
• Fosters communication and collaboration between Digital Operations and other departments (e.g., Manufacturing, Automation, Quality, IT)
• Promotes innovation and adoption of best practices within digital operations
• Ensures all team activities comply with cGMP standards and regulatory requirements
• Implement quality assurance measures to maintain data and record integrity
• Fosters effective communication between the Digital Operations team and other departments (e.g., MFG, Automation, Quality, FLBD)
• Promotes cross-functional collaboration to support digital integration in manufacturing processes
• Manages Digital Support on-call support including scheduling and on-call issue review
• Manages and develops direct reports from Digital Operations team
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
• Coaches and guides direct reports to foster professional development
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed
• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
• Other duties, as assigned

Basic Requirements

• High school diploma with 6+ years of experience
• Associate's degree with 4+ years of experience; OR
• Bachelor's degree with 2+ years of experience; OR
• Master's degree with 1+ years of experience; OR

• Experience directly supporting manufacturing and managing cross-functional initiatives in a manufacturing setting
• Experience working in a changing, project driven organization

Preferred Requirements

• Experience in in manufacturing of biological products, familiar with GMP/GLP requirements.
• Experience leading others in a pharmaceutical/biological manufacturing facility

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Ability to discern audible cues
• Ability to stand for prolonged periods of time
• Ability to sit for prolonged periods of time
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
• Ability to conduct work that includes moving objects up to 10 pounds

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]).