Manager, Project and Planning

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive health benefits

Retirement plan options

Generous paid time off

Leadership development

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Manager, Manufacturing Support to lead a talented team and ensure GMP-ready operations across a dynamic biopharma production environment. You will drive operational readiness, cross-functional collaboration, and continuous improvement, while guiding policy administration, training, and inspections readiness to support drug substance manufacturing.

This leadership role emphasizes people-first culture, accountability, and robust CAPA and

Qualifications

• High School diploma or GED with 10 years related experience
• Bachelor’s Degree with 6 years related experience
• Master’s Degree with 4 years of related experience

Responsibilities

• Provide oversight and lead operational readiness projects, including but not limited to GMP readiness
• Lead creation or transfer of manufacturing support team processes to ensure GMP readiness
• Manage, lead, and develop direct reports within the manufacturing support team
• Coordinate policy administration and time/expense reporting
• Coordinate non-batch activities and collaborate cross-functionally (CAPAs, investigations, batch schedules)
• Act as functional lead for regulatory inspections and audits
• Perform other duties as assigned

Skills

People leadership

GMP knowledge

Regulatory inspections

Project management

Cross-functional collaboration

Coaching

Education

Bachelor's Degree

Master's Degree

High School diploma or GED

Job description

Step into a leadership role where your guidance, operational rigor, and people-first approach will drive reliable, compliant production. As Manager, Manufacturing Support, you’ll build and lead a talented team, oversee critical manufacturing support activities, and partner cross-functionally to ensure operational readiness, continuous improvement, and inspection readiness across a dynamic, cGMP environment.

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: https://www.fujifilm.com/us/en/about/region/careers

About Us

Job Description

We are a collaborative, growth-focused manufacturing organization committed to quality, safety, and operational excellence. Our teams work at the intersection of science and execution, enabling consistent, compliant production in a highly regulated setting. We value inclusivity, accountability, and continuous improvement—and we support our leaders with the tools, autonomy, and trust to make a meaningful impact.

Responsibilities

During the project phase:

• Provide oversight and lead operational readiness projects, including but not limited to:
• Lead the creation or transfer (from an existing large-scale facility) of manufacturing support team business processes to ensure GMP operational readiness
• Lead, manage, and build the manufacturing support team
• Administer company policies that directly impact employees
• Complete required administrative tasks (e.g., time card approvals, time off approvals, expense reports)
• Perform other duties, as assigned

In Operations

• Manage, lead, and develop direct reports within the manufacturing support team while overseeing, organizing, and coordinating team tasks
• Foster an inclusive, people-first culture by creating meaningful development plans with direct reports and conducting regular 1:1s and skip-level 1:1s
• Provide oversight and coordinate non-batch activities and collaborate cross-functionally, including:
  • Ownership of manufacturing change controls and corrective and preventive actions (CAPAs)
  • Short flow investigations and management of alert/action limits
  • Detailed batch manufacturing schedules
  • Campaign materials readiness and coordination
  • Ensure continuous improvement; drive escalation and mitigation of manufacturing issues
  • Manufacturing training and curricula management
• Act as functional lead for regulatory inspections and audits
• Administer company policies that directly impact employees
• Complete required administrative tasks (e.g., time card approvals, time off approvals, expense reports)
• Perform other duties, as assigned

Minimum Qualifications (must Meet One Of The Following)

• High School diploma or GED with 10 years related experience OR
• Bachelor’s Degree with 6 years related experience OR
• Master’s Degree with 4 years of related experience
• 4+ years of experience managing, leading, and developing people
• Experience with regulatory inspections, investigations and change management
• Experience directly supporting manufacturing

Preferred Qualifications

• 6-10 years' experience in manufacturing operations
• Previous experience leading others in a manufacturing facility
• Experience working in a changing, project-driven organization
• Lean certification or similar certifications
• Experience with regulatory inspections, investigations and change management preferred
• Experience in pharmaceutical / biological manufacturing operations preferred
• Experience leading others in a pharmaceutical/biological manufacturing facility preferred

Knowledge, Skills, And Abilities

• Ability to collaborate with manufacturing and other functional areas
• Strong organizational skills and demonstrated project management capabilities
• Actively champions continuous improvement practices and ideas
• Advanced understanding of good manufacturing practices (GMP), inspection requirements, safety, and manufacturing operations
• Ability to coach, lead, and develop individual contributors

Physical/work Environment Requirements

• Ability to stand and sit for prolonged periods
• Ability to move objects up to 33 lbs (10 lbs frequently)
• Ability to discern audible cues
• May require occasional work in production-adjacent spaces; no respiratory protection or powered industrial truck operation required for this role
• No routine work at heights, in small/enclosed spaces, or in extreme temperatures

Benefits

We offer a supportive, development-focused environment with competitive rewards and resources to help you thrive.

• Competitive compensation aligned with experience and impact
• Comprehensive health benefits and retirement plan options
• Generous paid time off and company-recognized holidays
• Leadership development, coaching, and career progression pathways
• Opportunities to lead high-visibility operational initiatives and continuous improvement projects
• Inclusive culture that values diverse perspectives, psychological safety, and work-life balance
• Tools, training, and cross-functional exposure to support long-term career growth

Equal Opportunity Commitment: We are an equal opportunity employer and welcome applicants of all backgrounds. We make employment decisions based on qualifications, merit, and business needs. If you need a reasonable accommodation during the application or interview process, please let us know.

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 ([e-mail]).