Scientist 1, QC Microbiology

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

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 as 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
• Advanced LIMS experience
• Advanced experience with document control including writing and editing technical documents and presentations
  
  

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
• Investigations training (Trackwise or similar)
• LEAN/6S certification
• Familiarity with global regulatory guidelines and testing implications
  
  

Physical And Work Environment Requirements

Will work in environment which may necessitate respiratory protection X No Yes

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes

Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes

Ability to discern audible cues. No X Yes

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. x No Yes

Ability to stand for prolonged periods of time. No X Yes Daily up to 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)

Ability to sit for prolonged periods of time. No X Yes Daily up to 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes

Ability to operate machinery and/or power tools. X No Yes

Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes Will work in warm/cold environments X No Yes Range (If yes, specify approximate temperature ranges.)

Will work in outdoor elements such as precipitation and wind. X No Yes

Will work in small and/or enclosed spaces. No X Yes

Will work in heights greater than 4 feet. No X Yes

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).