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Position Overview

The Manager, QC Lab Support is responsible for leading the Lab Support team and the associated activities to ensure compliant and reliable testing for drug substance and drug product. This role applies broad knowledge and expertise in the areas of biopharmaceutical Quality Control for QC Chemistry, QC Bioassay, QC Microbiology, etc. and operational excellence. This Manager, QC Lab Support provides tactical and strategic direction to the QC Lab Support team and promotes the behaviors and principles that drive continuous improvement throughout the organization.

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

• Leads all areas of QC Lab Support (e.g., change controls, investigations, corrective action preventive action (CAPAs), data review, etc.)

• Develops QC Lab Support goals and strategy in alignment with the production schedule

• Drives Quality Control key performance indicators (KPIs) to support quality, continuous improvement, while escalating and mitigating issues

• Oversees training and development for all QC Lab Support staff

• Ownership and oversite of QC systems and business processes

• Interacts professionally with clients and partners to effectively communicate QC deliverables and commitments

• Leads discussions and responses during inspections, including area readiness prior to these inspections

• Drives and supports alignment and coordination between other FDB sites on QC topics

• Manages and develops direct reports from the Lab Support 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

• 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

• Experience managing and developing direct reports and teams

• Extensive experience with Analytical and/or Microbiology methods

Preferred Requirements:

• 5+ years of experience in a GMP environment

• Experience working in a contract manufacturing or testing organization

• Experience with statistical experimental design and data analysis with JMP software

Physical and Work Environment Requirements:

Ability to discern audible cues.

Ability to stand for prolonged periods up to 240 minutes.

Ability to sit for prolonged periods up to 240 minutes.

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

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions pounds.

Will work in small and/or enclosed spaces.

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]).

**Job Locations** _US-NC-Holly Springs_

**Posted Date** _1 month ago_ _(4/23/2025 3:48 PM)_

**_Requisition ID_** _2025-34364_

**_Category_** _Quality Control_

**_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_