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 solutions to 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.

About the Role

The QC 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.

What You'll Do

• 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 Diosynth 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.

Minimum 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

Preferred Requirements:

• 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 and Work Environment Requirements:

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Abiltiy to stand for prolonged periods of time up to 240 minutes.

Abiltiy 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.

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 FDBN_PNC@fujifilm.com.

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.