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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 Senior Director, Media and External Relations role is part of the global Corporate Affairs team, supporting all of our sites around the globe. The role is essential in managing the company’s external communications and reputation, with a strong emphasis on building relationships with top-tier U.S. media outlets. You will be responsible for crafting and executing media strategies, monitoring media coverage, and creating content for our external channels. A key aspect of this role is collaborating with teams geographies Europe, US and Japan and functions such as finance, commercial, and investor relations, ensuring aligned messaging that resonates with key external...
The Scientific Applications Specialist provides technical field support for existing and new products of VisualSonics and its ultra high frequency ultrasound and photoacoustic technology. The Applications Specialist role is to be a subject matter expert in preclinical ultrasound and photoacoustic imaging. They will demonstrate the value of VisualSonics products through successful sales demonstrations, customer education and training.
**This is a US based travel position; however, some international travel may be...
The Environmental, Health & Safety (EHS) Specialist supports and implements the company’s Safety, Environmental, and Health Programs to ensure compliance with local, state, and federal regulations, as well as corporate policies. This role fosters a culture of safety and environmental stewardship while driving proactive measures, continuous improvement, and supporting EHS initiatives in laboratory and biosafety settings.
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.
QVS Engineering is a growing team whose mission is to improve the quality of FFSS products through their life-cycle, proactively handling component and module obsolescence while strategically reducing COGS (Cost of Goods Sold). The Senior Electrical Engineer (QVS) works with a cross-functional team to resolve complex ultrasound systems’ quality issues, defining and implementing innovative modifications to existing electrical designs to reduce cost while still maintaining high quality, and handling obsolescence of electrical/electronic components. Specific requirements include electronic troubleshooting experience using advanced lab equipment on circuit boards with large...
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.
As a member of our sales team, you will sell portable ultrasound systems in a consultative, professional and high velocity sales environment. This includes creating primary market demand for FUJIFILM Sonosite products by networking, cold calling, and educating users in hospitals and the physician office market on the value of FUJIFILM Sonosite’s hand-carried compact ultrasound systems and tools.
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
As the Manager, Data Enablement & Analytics, you will understand that data is the key to the future success of the company, and this role is essential to ensuring we have reliable data insights to inform business decisions at every level. This position will be responsible for developing a strategy to ensure our processes and systems are set up to create the data insights the business is looking for. The key to success in this role is creating a data environment that produces reliable insights in every area of the business.
The Senior Director Quality Operations is responsible for QA oversight of CGMP manufacturing operations and areas at one of our manufacturing facilities at FDBT. Lead the Quality Operations organization to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders. Direct all QA on-the-floor (QAOTF), batch record review (BRR), and product disposition activities including QA review and approval of any associated deviations, CAPAs, and change controls to meet established targets for right first time execution and on-time delivery. Ensure products are manufactured to meet all CGMP...