Microbiologist - Laboratory Testing

Company Overview The Analyst, QC Microbiology is responsible for the key operational aspects of the QC Microbiology laboratory. This role performs microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples under minimal supervision. The Analyst, QC Microbiology is responsible for all activities associated with testing in accordance with written procedures. This role participates in writing or assisting with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and on-boarding of new staff, as needed and in addition to regular work duties and assignments.

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. 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: Supports environmental and utilities monitoring sample collection

Provides input to define protocols for sample collection and logistics, ensuring compliance with regulatory standards

Coordinates testing materials and supplies

Plans and ensures materials are stocked. Partners with procurement, inventory management, and distribution to optimize laboratory operations

Performs advanced microbiology testing by generating complex test data for in-process samples, raw materials, and environmental samples, providing analysis for Bioburden, Endotoxin, and microbial findings

Performs Sterility testing and validation processes and participates in isolator qualification procedures and ensures effective routine operations and maintenance

Ensures accuracy and security of laboratory information, implementing tools and protocols for data management

Conducts comprehensive reviews of laboratory testing results and provides analysis and interpretation of results, identifying trends and making informed recommendations

Under the direction of management, troubleshoots issues with laboratory assays and identifies underlying causes of assay failures and develops strategic solutions to improve test reliability

Leads general laboratory support and maintenance initiatives by maintaining analytical instruments and laboratory resources, coordinating purchases and receipt of essential supplies

Supports implementation and monitoring of CAPAs

Partners with management to initiate and coordinate resolution for deviations and non-conformance events within quality systems

Participates in project developments from concept through execution, ensuring alignment with organizational goals

Minimum Requirements Bachelor’s degree in scientific discipline with 0-1 years of experience

Preferred Requirements BS within Microbiology, Chemistry, Biochemistry, Biology

2+ years of Intermediate experience in a GMP QC Microbiology

Laboratory, knowledge of all compendial test methods (Bioburden, Endotoxin, sterility testing) preferred

Ability to troubleshoot and maintain laboratory equipment and instrumentation

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.