Click column header to sort
Summary: The Quality Control Analyst position, under general direction, will be responsible for performing review of routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory. The data reviewer is responsible to ensure activities are reviewed in an efficient and cGMP compliant manner.
Summary: The Manufacturing Director is responsible for the planning, directing, and coordinating activities related to the manufacturing processes for the start-up of the new Flexible BioManufacturing Facility – 200 (FBF – 200) while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics. The Manufacturing Director – FBF 200 will be responsible for the cGMP production, manufacturing and systems that support the manufacture of virus-related vaccines and biotherapeutic products in a BSL 2 state-of-art facility.
Summary: This position will be responsible for knowing all the applicable Biomanufacturing regulations and ensuring that they are followed. This position will coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials in support of client submissions to regulatory agencies.
Summary: The electronic Quality Management System (eQMS) Systems Administrator will be the Quality organization's Subject Matter Expert (SME) as it relates to the configuration, implementation, analysis as well as the maintenance of the (eQMS) across multiple FDB facilities.
Summary: The Manufacturing Supervisor – Drug Product Operations will work directly with the processes associated with the Vanrx SA25 Automated Filling machine. This includes but is not limited to formulation, aseptic filling, vial inspection and vial labeling following cGMP procedures. This individual will also supervise a team of employees directly or indirectly in the production of Drug Product at FUJIFILM Diosynth.
Summary: The CAPEX Project Coordinator, under the supervision of the Director of Engineering and Technology, will be responsible for the support of capital projects documentation through the management of initiation and close out documents, schedule tracking, and multi-departmental approval routing.
Fujifilm Diosynth Biotechnologies, U.S.A., Inc. is seeking a Downstream Production Technician to work in our Downstream Manufacturing group. The successful candidate will execute Development and Production processes as well as the accompanying documentation. This is a night shift position (7:00 pm - 7:00 am). The candidate hired will be working on day shift for the first six months for training, and then transition to the night shift.
The Associate Director is responsible for delivering contracted product per the revenue forecast and establishing a central production plan. This position is also responsible for inventory levels, material readiness and various monthly reports. Additionally, this position is responsible for conveying company expenditures, influencing the spend when possible and facilitating the contract process between internal customers and external parties. This is done while also minimizing FDBU financial and legal exposure and also promoting a culture of compliance.
Fujifilm Diosynth Biotechnologies U.S.A., Inc. is seeing an Upstream Production Technician. The successful candidate will be performing cell culture sterilization techniques, support mammalian cell culture manufacturing processes, sustaining purification of bio-pharmaceuticals, operate various process equipment, documenting daily manufacturing operations in a cGMP environment, working with single- use and stainless steel bioreactors, fermentation, and/or filtration. This is a night shift position (7:00 pm - 7:00 am).
FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Program Manager to work at our RTP, NC location. The successful candidate will be accountable for the planning & delivery of programs from the point of contract signature (Scope of Work / Letter of Intent / Contract) through program closure. They will ensure we provide services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance). The Program Manager typically handles an average load of 2-4 programs receives and receives coaching & guidance from the Head of Program Management.
Summary: The Calibration Coordinator assists the Calibration team to ensure cGMP compliance and on time calibration work performed at Fujifilm Diosynth Biotechnology facilities in College Station Texas. This individual will assist in implementing and scheduling the calibration of instruments and devices in the facility with an emphasis on planning and scheduling calibration. This individual may also assist in preparing SOPs and calibration instructions for the new systems entering the system, scheduling the periodic calibration of those instruments during their life cycle, and the proper documentation when those instruments and devices may either fail calibration or be retired from the system.
The Fixed Assets Accountant will analyze financial status by collecting, monitoring, and studying data; recommending actions. Financial planning and strategy along with process improvement and problem solving are key responsibilities with special focus on capital projects and fixed assets.
Summary: The Materials Management Specialist is responsible for drafting and implementing supply chain management procedures governing the receiving, warehousing, ordering, shipping and internal distribution of cGMP (current Good Manufacturing Practices) and non-GMP materials.
FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Senior Process Scientist/Engineer. Join our team of passionate engineers and scientists as we drive cutting-edge biopharmaceuticals from R&D lab to commercialization. Our Senior Engineers are responsible for many aspects of technical transfer of a wide variety client projects into our manufacturing facilities. From first clinical batch, to PPQ, to Pre-Approval Inspection – you will be there. No two days are alike. Our Senior Engineers troubleshoot complex technical issues to support project success. Senior Engineers provide comprehensive technical solutions throughout the organization. If you are ready to grow your career, work hard, and make a substantial impact in patients’ lives consider joining our team.
The Head of Program Management will be responsible for leading, directing and managing a team of Program Managers responsible for program delivery at Fujifilm Diosynth Biotechnologies in order to achieve the annual company revenue plan while providing outstanding customer service for all clients from pre-clinical to commercial manufacturing.
The incumbent will be responsible for leading the site S&OP process to ensure that the site delivery plans are aligned with the budget, that the resource and asset strategies of the business are based on forecasts of customer demand while pro-actively identifying and mitigating risks.
The Manufacturing Manager, Upstream – FBF 200 is responsible for assisting in the planning, directing, and coordinating of the activities related to the Upstream manufacturing processes for the start-up of the new Flexible BioManufacturing Facility – 200 (FBF – 200) while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics. The Manufacturing Manager, Upstream will oversee the cGMP production and Upstream manufacturing systems working directly with cell culture and viral propagation techniques, cell culture and bioreactor operations, bacterial and fermentation operations, pDNA, protein, and yeast related operations, and aseptic techniques while following cGMP procedures.
Summary: The Site Services Supervisor, under the supervision of the Associate Director, Facilities Engineering, will be the individual primarily responsible for coordinating and managing the various contractors and staff that support the day-to-day operations of the FDBT facilities and grounds, including but not limited to various aspects of security, janitorial services, landscaping/lawn maintenance, uniform services, extermination/pest control, space planning, leased company vehicles, etc. This position will be responsible for monitoring the performance of these services against the contract specifications, and execute changes and modifications to those contracts as necessary for improvement as needed.
This position will also manage small projects, as well as, work with other managers and supervisors to promote the efficiency and safety of routine operations and events. The Site Services Supervisor will also monitor the facilities for unsafe conditions and operations and work with the Safety Team to eliminate hazards when detected.
The Manufacturing Process Engineer I – TBF 100 is an entry-level position in the Manufacturing Technology Support (MT&S) department in support of the SATURN Project located at the Texas BioManufacturing Facility – 100 (TBF – 100) in College Station, Texas. This position will report directly to the Associate Director, MT&S, but may also jhave a functional reporting relationship to a senior colleague on a project to project basis.
Works independently, and with colleagues, to provide expertise and assistance for the design, development, standardization and maintenance of an operational biotechnology utilized in the manufacture of proteins and drug substances. This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit. Operational biotechnologies include: Isolators and their use in cell propagation, Cell Culture/Single Use Technology, Dispensing and Mixing and Buffer Preparation. This position will also create training programs and perform training for manufacturing technicians in the unit operation categories.
The EHS Specialist, under the supervision of the Senior EHS Manager, will be responsible for development and application of various safety and compliance programs at Fujifilm Diosynth Biotechnologies Texas (FDBT). Programs include occupational health and safety, fire safety, emergency response, management of hazardous and other special wastes, industrial hygiene, respiratory protection and environmental programs within the scope of EHS. This position is expected to be aware of all applicable OSHA and environmental regulations as they apply to FDBT and help maintain compliance with local, state and federal regulations for occupational and environmental safety.
The EHS Specialist will be familiar with the processes involved in pharmaceutical manufacturing and provide EHS support, as applicable
Summary: The Calibration Technician I is responsible for maintaining and improving the cGMP Calibration Programs at the Fujifilm Diosynth Biotechnology Texas (FDBT) facilities in College Station Texas. This includes complex bio-pharma processing equipment such as Mobile Bio Processing Rooms, Mobile Clean Rooms, Bioreactors, Fermenters, centrifuges of various sizes and process, filtration skids, columns, critical water systems and a variety of analytical and test equipment.