Scientist 1, QC Microbiology

Position Overview

The Scientist 1, QC Microbiology supports a broad range of microbiological functions for both raw materials and drug product manufacturing support. This role manages multiple assignments of increasing complexity and responsibility within the Quality Control laboratory in support of these two areas. This role follows procedures and has mastery of a wide variety of microbiological methods specific to raw material and drug product manufacturing and supporting data management processes. The Scientist 1, QC Microbiology effectively and efficiently manages complex or difficult tasks with expertise within the assigned disciplines. This role initially supports the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments are required.

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

• Performs non-routine complex testing, identifies requirements and executes actions as part of change control process.
• Assists and guides others in the lab with routine testing
• Performs high throughput, right-first time work to meet production schedules and project milestones with minimal/no supervision
• Leads qualification and study directed testing activities
• Reviews and evaluates advanced lab testing results
• Acts a qualified trainer and Subject Matter Expert (SME) of multiple tests
• Authors, reviews, and edits documents and study protocols
• Supports intermediate investigations of OOS assays and events
• Ensures compliance with cGMP and participates in audits and inspections
• Supports laboratory management and mentors' others on the team, as needed
• Leads LEAN lab and six sigma principles and applies them to laboratory processes
• Acts as project leader for projects in the lab and department
• Leads audit readiness and participates/supports for the team
• Performs other duties, as assigned

Minimum Requirements:

• Bachelor's degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 5+ years' experience OR
• Master's degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 3+ years' experience OR
• PhD with 1+ years of applicable industry experience
• 3+ years of experience working in a regulated GMP environment
• Expert understanding of GMP, GLP, GDP requirements
• Experience and proficient knowledge in Microbiology theory
• Experience and proficient knowledge of Microbiology testing and laboratory experience, specific to both Drug product manufacturing
  support and raw materials testing.

Preferred Requirements:

• SME level knowledge in Microbiology theory
• SME level knowledge of Microbiology testing and laboratory experience, specific to both Drug product manufacturing support and
  raw materials testing

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.

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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 (View email address on hirelifescience.com).