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Virology Sr. Analyst I

2 months ago

Holly Springs, United States FUJIFILM Holdings America Corporation Full time

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US

About the Role

The QC Virology Sr. Analyst I 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 QC Virology Sr. Analyst I 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 QC Virology Sr. Analyst I 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. The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success.

What You'll Do

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

Minimum Requirements:

Bachelor's degree in Science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 3+ 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.

Preferred Requirements:

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.

Ability to learn and incorporate lean lab and six sigma six principles into daily work environment.

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.

Ability to ascend or descend ladders, scaffolding, ramps, etc.

Abiltiy to stand for prolonged periods of time up to 60 minutes

Abiltiy to sit for prolonged periods of time up to 60 minutes

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.

Will work in small an/or enclosed spaces.

Will work in heights greater than 4 feet.

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email .

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. #J-18808-Ljbffr