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 is required. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the 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: What You’ll Do Perform non‑routine complex testing, identify requirements and execute actions as part of the change control process. Assist and guide others in the lab with routine testing. Perform high‑throughput, right‑first‑time work to meet production schedules and project milestones with minimal or no supervision. Lead qualification and study‑directed testing activities. Review and evaluate advanced lab testing results. Act as a qualified trainer and subject‑matter expert (SME) of multiple tests. Author, review, and edit documents and study protocols. Support intermediate investigations of OOS assays and events. Ensure compliance with cGMP and participate in audits and inspections. Support laboratory management and mentor others on the team, as needed. Lead LEAN lab and Six Sigma principles and apply them to laboratory processes. Act as project leader for projects in the lab and department. Lead audit readiness and participate/support the team. Perform other duties as assigned. Minimum Requirements Bachelor’s degree in chemistry, biochemistry, microbiology, or another relevant scientific discipline with 5+ years’ experience. Master’s degree in chemistry, biochemistry, microbiology, or another relevant scientific discipline with 3+ years’ experience. PhD with 1+ years of applicable industry experience. 3+ years of experience working in a regulated GMP environment. Expert understanding of GMP, GLP, and GDP requirements. Experience and proficient knowledge in microbiology theory. Experience and proficient knowledge of microbiology testing and laboratory work, specific to both drug product manufacturing support and raw materials testing. Preferred Requirements SME level knowledge in microbiology theory. SME level knowledge in microbiology testing and laboratory work, 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. 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 click.appcast.io). #J-18808-Ljbffr FUJIFILM Biotechnologies