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 Bioassay Scientist 2 is a technical subject matter expert (SME) responsible for the QC cell-based and plate-based analytical methods. The QC Bioassay Scientist 2 ensures GMP compliant laboratory operations in accordance with regulatory guidelines. This role performs technical/compliance reviews and approve analytical results. The role also approves laboratory exceptions, invalid assays, deviations, change controls and corrective and preventative actions (CAPAs). The QC Bioassay Scientist 2 will authors, reviews and approves SOPs, protocols, and technical reports. When needed, the QC Bioassay Scientist 2 trains other QC Bioassay laboratory associates and execute routine analytical methods. The role also serves as the SME for QC Bioassay in cross-functional projects and meetings.

What You'll Do

• Performs cell-based and plate-based analytical methods including protein binding assays (e.g. ELISA, Dot Blot, etc.), cell-based potency assays, cell culture maintenance, and residual testing for DNA, Host Cell Protein (HCP), Protein A/G
• Ensures analytical testing of in process, drug substance (DS), drug product (DP) and stability samples is performed according to appropriate GMP regulations
• Performs laboratory work and peer reviews of analytical data in support of tech transfer and routine manufacturing
• Executes and reviews method qualification, transfer and validation activities in support of tech transfer and maintain lab equipment
• Monitors assay performance and implements improvements that ensure quality and efficiency within QC Bioassay
• Troubleshoots and investigates deviations and invalid assays performed in QC Bioassay
• Authors, reviews, and approves SOPs, protocols, reports, change controls, Trackwise deviations, out-of-specification (OOS) and out-of-trend (OOT) investigations, and CAPAs for the QC Bioassay team, as needed
• Represents QC Bioassay in cross-functional collaborations with QC Analytical Development, QC Virology, QC Program Management, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives
• Manages and monitors lab activities as needed
• Provides training for QC Bioassay associates
• Provides technical support as the QC Bioassay SME during customer visits, audits and regulatory inspections
• Participates in risk and gap assessments during project scoping as needed
• Collaborates with the LIMS team and IT department to build new method functionality that meets end-user and customer requirements
• Liaises with Contract Laboratory Organizations (CLOs) to monitor method execution and the timely delivery of results as needed
• Performs other duties, as assigned

Minimum Requirements:

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

• M.S. in Virology, Microbiology, Biology, Chemistry, Biochemistry, Biological Sciences or related science field with 7+ years of experience, OR
• Ph.D. in Virology, Microbiology, Biology, Chemistry, Biochemistry, Biological Sciences or related science field with 5+ years of experience
• 4-6 years experience in a GMP environment

Preferred Requirements:

• 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.

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.

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.