Fujifilm Diosynth Biotechnologies

Position Overview

The Manager, QC Microbiology is responsible for contributing to key functional, tactical, and operational aspects of the QC group at Fujifilm

Biotechnologies. Project management, initiation of process improvements, liaison for, qualification and validation activities, modeling the leadership competencies, aiding in the development of peers and performing QC approval, as required. The Manager, QC Microbiology is proficient in their understanding of Quality Systems and applies that knowledge in leading projects, coaching, and continuous improvements of systems cross-functionally.

Company Overview

FUJIFILM Diosynth 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

Job Description

What You'll Do

• Accountable for GMP compliant laboratory operations according to EU GMP and 21 CFR part 210, 211, 820, 11 and other applicable GMP guidelines
• Mentors’ teams cross-functionally as a representative of the QC Microbiology laboratory
• Coordinates the review of analytical data to support test validation, qualification and certification activities. Performs investigations, manages complex issues, barriers and problems to support team success. Approve data reports within the team and area of discipline/focus, including approval of results
• Authors protocols, change control requests, and Quality Technical Reports for ensuring successful execution of, qualification, analytical

improvement projects, in collaboration with cross-functional teams, as appropriate

• Provides technical leadership through effective project management, status tracking, presentations, and communication
• Proactively identifies technical gaps and areas for improvement related to quality. Process and lead internal and external audits proficiently, including commitments on follow up
• Within team & site management, serves as External Leadership for the project
• Represents QC interdepartmentally on QC projects with limited support for efficient and collaborative interaction with internal and external stakeholders
• Routinely provides direction to subordinates. Ensure team motivation through initiatives to ensure a positive working environment and values team over individual success. Mentors junior members of the team in quality systems, process improvements
• Set requirements; deliverables, and measurable goals & targets, mitigation plans, which are aligned to quality directive, regulatory guidance, business imperatives
• Ensures issues/deviations are mitigated appropriately
• Manages complex problem solving, providing mitigation/outcome to management/team. Decisions at this level include those that have potential compliance impact to methods, results, product, and/or Quality systems, decisions with impact to customers, or pertaining to personnel issues that must be handled with consultation and recommendations to management. Supports key business strategies
• Conducts approval of complex reports, data of others; Leads complex problem solving through facilitation/escalation. Conducts impact assessment related to compliance (e.g.; global directives, audit finding/readiness, deviations).
• Provides technical support during audits/inspections
• Ensures adherence to all regulatory licenses and regulations, serving as a subject matter expert in multiple disciplines, interfacing with key customers
• 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
• Performs other duties, as assigned

Minimum Requirements:

• Bachelor’s degree in Chemistry, Microbiology, Biological Sciences, Engineering or related science with 7+ years of experience OR
• Masters degree in Chemistry, Microbiology, Biological Sciences, Engineering or related science with 5+ years of experience OR
• Ph.D. in Chemistry, Microbiology, Biological Sciences, Engineering or related science with 3+ years of experience
• 2-5 years of people management experience
• Experience working in a regulated GMP environment

Preferred Requirements:

• 5+ years of experience in a GMP environment

Physical and Work Environment Requirements:

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Ability to stand for prolonged periods of time up to 240 minutes.

Ability to sit for prolonged periods of time up to 240 minutes.

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

Will work in warm/cold environments.

Will work in heights greater than 4 feet.

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 (FDBN_PNC@fujifilm.com).