Sr Analyst I, QC Virology

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.

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.

Requirements

• Bachelor's degree in Science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 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 a GMP Environment.
• Experience with LIMS software preferred.