Scientist 1, QC Microbiology

Fujifilm•Holly Springs, NC

17h

About The Position

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

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

Nice To Haves

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

Responsibilities

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