The QA Specialist III, QA Compliance, will be responsible for the review and approval of commissioning/qualification/Compliance protocols, reports, computer automation Compliance protocols and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III, QA Compliance, will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.  

The Assistant Scientist – Upstream Process Development is an entry level position for graduates with no prior experience or training. The individual will learn and assist in the development and characterization of the upstream process of customer programs, and technology transfer to the manufacturing group as appropriate. This individual will be expected to require training on laboratory instrumentation and then use instrumentation to perform elementary lab experiments and document results appropriately.

The Automation Engineer 3, DSM Downstream will provide support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support.

The Manufacturing Specialist 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.   

Utility Maintenance 2 will perform corrective maintenance, routine maintenance, and preventive maintenance on plant utilities equipment following Standard Operating Procedures (SOPs). Complete work orders, daily logs and forms following Good Manufacturing Practices (cGMP) documentation practices and quality standards in a Pharmaceutical Manufacturing plant. Utilities to include high-pressure steam boilers, process wastewater treatment, chillers, water purification systems (water softening and carbon bed filtration, reverse osmosis, deionization equipment, sanitary pumps, and associated equipment), compressed air and dryers, and chilled water

The Tech 3, Instrumentation & Controls (I&C) is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility-wide equipment, and facility systems through effective Preventive and Corrective Maintenance and Calibration practices and know-how.

This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

The Project Manager role provides project management and communications support for complex, critical projects related to the development and operation of a greenfield Biotech Manufacturing facility. The primary focus is on establishing and facilitating continuous improvement and risk management initiatives to ensure the new site is adequately prepared for both initial startup and ongoing operations. This position leads, facilitates and

The Manufacturing Associate works as part of the manufacturing team to deliver high quality cell therapy materials during process transfers, routine production, and technology improvements. This position contributes to the successful delivery of released product in support of clinical trials and commercial production.  

The QC Analytical Development (AD) Chemistry Scientist 2 is responsible for coordinating the transfer of analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN). The QC AD Chemistry Scientist 2 ensures GMP compliant laboratory operations in accordance with regulatory guidelines. This role coordinates analytical method transfers from clients, including the following analytical methods: chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary...

The QC AD Chemistry Sr. Analyst I works with limited direction to support the execution of analytical method transfers and validations for drug substance (DS) and drug product (DP) manufacturing into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN). The analytical chemistry methods used in biological product manufacturing include chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The QC AD Chemistry Sr. Analyst I adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical...

The Analytical Development (AD) Tech Transfer (TT) Scientist 2 manages and coordinates the transfer of drug substance and drug product QC analytical methods from customers into the large-scale manufacturing facility, from first campaign through commercialization (clinical through process performance qualification/commercial). This role interfaces with customers and cross-functional teams to scope analytical testing plans and achieve project milestones. This role authors/reviews transfer plans, method transfer documents, transfer summary reports and specification justification reports, as needed. This role effectively communicates and operates between different teams, ensuring...

The Technician 2, Maintenance is responsible for the installation, maintenance, and repair of process related systems/equipment. Ensure these systems meet the stringent requirements of pharmaceutical manufacturing. Also responsible for conducting regular inspections and preventive maintenance on process related equipment to ensure equipment is operating efficiently with minimal downtime.

The Tech 2, Instrumentation & Controls (I&C) is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility-wide equipment, and facility systems through effective Preventive and Corrective Maintenance and Calibration practices and know-how.

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...

Manager, QA Drug Substance    Are you a skilled leader ready to drive impactful change in Quality Assurance? As the Manager, QA Drug Substance, you will use your leadership skills to optimize processes and form strategic partnerships with CQV and Engineering teams. Your ability to lead and inspire teams will be crucial in enhancing quality standards during both the project phase and...

The Clean Utilities Engineer 3 provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Clean Utilities, including reverse osmosis/electrodeionization (RO/EDI) skids, water for injection (WFI), purified water (WPU), Clean gasses and applicable waste systems. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with troubleshooting equipment issues to maintain overall plant reliability. Additional...

The Black Utilities Engineer 3 provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Black Utilities, including Chilled Water Systems, Steam Boilers, Cooling Towers, HVAC and Glycol Chiller and Compressed Air systems. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with troubleshooting equipment issues to maintain overall plant reliability.

Readiness Engineer I is an entry to mid-level position in the Manufacturing department. This position will report directly to the US/DS Readiness Lead but may also have a functional reporting relationship with a senior colleague on a project-to-project basis.   This role works independently and with colleagues to provide expertise and assistance for the design, development, standardization, and maintenance of operational biotechnology utilized in the manufacture of proteins and drug substances. This person...

TheSenior Engineer functions independently and productivelywithin a team based