Manager, Project and Planning
About Us
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.
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the 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 cultivate a culture that fuels purpose, energy, and drive—what we call Genki.
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: healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.”
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
- Manage manufacturing training and curricula
- 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
Requirements
Minimum Qualifications (must meet one of the following):
- 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
- 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
- Experience in pharmaceutical/biological manufacturing operations
- Experience leading others in a pharmaceutical/biological manufacturing facility
Skills
- 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
- 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