Scientist 2, Quality Control Virology

Position Overview

The Quality Control Virology Scientist II is a technical subject matter expert (SME) responsible for the 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 Scientist II will ensure GMP compliant laboratory operations in accordance with regulatory guidelines. This role will perform technical/compliance reviews and approve analytical results. The role will also approve laboratory exceptions, invalid assays, deviations, change controls and corrective and preventative actions (CAPAs). The QC Virology Scientist II will author, review and approve SOPs, protocols, and technical reports. When needed, the QC Virology Scientist II will train other QC Virology laboratory associates and execute routine analytical methods. The role will serve as the technical SME for QC Virology in cross-functional projects and meetings.

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:

Job Description

Responsibilities:

• Perform 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.
• Ensure analytical testing of in-process samples are performed according to appropriate GMP regulations.
• Perform laboratory work and peer reviews of analytical data in support of tech transfer and routine manufacturing.
• Execute and review method qualification, and validation activities and maintain lab equipment.
• Monitor assay performance and implement improvements that ensure quality and efficiency within QC Virology.
• Troubleshoot and investigate deviations and invalid assays performed in QC Virology.
• Author, review, and approve SOPs, protocols, reports, change controls, Trackwise deviations, out-of-specification (OOS) and out-of-trend (OOT) investigations, and CAPAs for the QC Bioassay/Virology team, as needed.
• Perform viral risk assessments for incoming new raw materials and document assessment in a technical report as part of change management.
• Represent QC Virology in cross-functional collaborations with QC Analytical Development, QC Program Management, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Biotechnologies objectives.
• Manage and monitor lab activities as needed.
• Provide training for QC Virology associates.
• Provide technical support as the QC Virology SME during customer visits, audits and regulatory inspections.
• Participate in risk and gap assessments during project scoping as needed.
• Collaborate with the LIMS team and IT department to build new method functionality that meets end-user and customer requirements.
• Liaise with Contract Laboratory Organizations (CLOs) to monitor method execution and the timely delivery of results as needed.

Education/Experience Requirements:

• B.S. in Microbiology, Virology, Biology, Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 9+ years of experience
• 9+ years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO)
• 4-6 years experience in a GMP environment

Education/Experience Preferred:

• M.S. in Virology, Microbiology, Biology, Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 6+ years of experience, OR Ph.D. in Virology, Microbiology, Biology, Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience
• Experience working in a Virology lab in an GMP Environment
• Experience troubleshooting viral infectivity assays, growing viral stock, growing and cryofreezing cell banks stocks
• Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system)

Physical Requirements/Work Environment:

• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time up to 240 minutes.
• Ability to sit for prolonged periods of time up to 240 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.
• Will work in warm/cold environments.

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.

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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 ([email protected]).