Sr Analyst 1, QC Virology

Fujifilm•Holly Springs, NC

2d•Onsite

About The Position

The Sr. Analyst 1, QC Virology works with limited direction to execute QC analytical methods requiring aseptic technique, including viral infectivity assays, mammalian cell culture, growth and purification of viral stocks, titering of viral stocks, and PCR-based methods. The Sr. Analyst 1, QC Virology adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identifies laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs). The Sr. Analyst 1, QC Virology is primarily responsible for executing routine Virology methods in support of manufacturing, supporting laboratory execution of method qualifications, maintaining cell banks and stocks, growing viral stocks, and training other QC Virology laboratory associates. 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

Requirements

Bachelor’s degree in Science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific disciplinewith 2+ years of relevant experience
3+ years laboratory experience
1-3 years GMP laboratory experience
Experience working with BSL1 and BSL2 viruses in a GMP lab environment including mammalian cell culture propagation and maintenance.

Nice To Haves

Master’s degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 1 year of relevant experience
Experience working in a Virology lab in an GMP Environment
Experience with LIMS software preferred

Responsibilities

Executes analytical methods that require aseptic techniques, including viral infectivity assays, qPCR assays, 28-day and 14-day Adventitious Agent assays, growth and purification of viral stocks, titering of viral stocks, and cell culture maintenance
Ensures analytical testing of in-process samples is performed according to appropriate GMP regulations
Ensures analytical testing data is captured in LIMS software
Reports assay performance and assists with the implementation of improvements that ensure quality and efficiency within QC Virology
Identifies and follows up on excursions and deviations and initiates corrective and preventative actions (CAPAs)
Coordinates and supports QC Virology lab activities as needed
Provides training for QC Virology associates
Authors and reviews SOPs and technical reports
Works cross-functionally with other QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives
Performs other duties, as assigned