FUJIFILM Biotechnologies
Scientist 1, QC Microbiology
FUJIFILM Biotechnologies, Holly Springs, North Carolina, United States, 27540
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Scientist 1, QC Microbiology
role at
FUJIFILM Biotechnologies .
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.
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.
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).
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Scientist 1, QC Microbiology
role at
FUJIFILM Biotechnologies .
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.
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.
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).
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