Virologist

GMP environment is required for this role.

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)