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Summary: Fujifilm Diosynth Biotechnologies, Texas, Inc. is offering part time work (10-20 hours per week) for college students majoring in Life Sciences or preferably Biological Sciences. We offer a supportive, collaborative teaching environment to develop our student worker’s skills and identify their career goals. This is a great opportunity to gain invaluable experience working for an industry-leading biopharmaceutical contract manufacturing organization. The student worker will work in direct contact with the department staff to assist with department specific duties as requested. The duration of the position will be determined between the supervisor, and Human Resources.
Summary: The Sr. Manufacturing Process Engineer is a mid-level position in the Manufacturing Technology Support (MT&S) department in support of the SATURN mAb manufacturing facility located at the Texas BioManufacturing Facility – 100 (TBF – 100) in College Station, Texas. The SATURN Platform utilizes entirely single use technology and is a multi-stream, multi-product facility that manufactures clinical and commercial products. As a CDMO, customer liaison is a vital part of our business and the Technical Operations team act as the point of contact for our customers during manufacturing execution. This position will report directly to the Manager, Technical Operations, but may also have a functional reporting relationship to a senior colleague on a project-to-project basis.
The Sr. Manufacturing Process Engineer works independently, with minimal supervision, and leads projects and 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 will be 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, Filtration, Chromatography and Final Filtration. Core manufacturing technologies include Weigh and Dispensing and Mixing and Buffer Preparation.
Fujifilm Diosynth Biotechnologies, U.S.A., Inc. is seeking Downstream Production Technicians (all levels) to work in our Downstream Manufacturing group. The successful candidate will execute Development and Production processes as well as the accompanying documentation. This position could either be a day shift position (7:00 am – 7:00 pm) or a night shift position (7:00 pm - 7:00 am). The candidate hired will be working on day shift first for training, and then transition to the night shift if assigned to nights.
Summary:The Facilities Support Operations Supervisor under the supervision of the Associate Director, Facility Engineering will be responsible for maintaining, administering and improving the Computerized Calibration & Maintenance Management System (CCMS/CMMS) in support of the operation of the Texas Biological Facility (TBF), the Flexible Biological Facility (FBF), as well as the integration of the National Center for Therapeutic Manufacturing (NCTM) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). Primary responsibilities include managing the daily maintenance operations including the CCMS/CMMS administration, the work order lifecycle process, the Planning & Scheduling of Maintenance and Calibration activities, and the MRO inventory across multiple facilities. This position with assigned personnel and/or contractors will be responsible for the oversight of the maintenance support operations through strict adherence to Standard Operating Procedures (SOPs) and cGMPs in a Pharmaceutical Manufacturing Facility. This position will interact with other maintenance and technical trades, such as manufacturing operators, engineers, maintenance and calibrations technicians, validation, quality and external suppliers in order to provide a high level of excellence over the maintenance operational activities of FDBT. Also, this position should ensure that departmental milestones and goals are met in accordance to the approved plans and budgets.
The Program Coordinator I, with direct supervision, will support site business planning and customer projects by maintaining relevant databases and liaising with Program Directors.
Summary: The Technical Operations – Technical Writer will be responsible for drafting batch summary reports for executed manufacturing campaigns to support client needs. Additionally, will be responsible for the creation and revision of procedures and protocols to support manufacturing activities. This role requires an understanding of GMP monoclonal antibody production, as well as an active approach to learning the latest best practices across the business.
The Program Coordinator II, with minimal supervision, will support site business planning and customer projects by maintaining relevant databases and liaising with Program Directors.
Summary: The Manufacturing Readiness Coordinator I assists the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones.
Summary: The Manufacturing Readiness Coordinator II assists the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones.
Summary: The Manufacturing Compliance Coordinator I leads the tracking, coordination, and closure of Manufacturing CAPAs, change controls and deviations, and assists in supporting the timely release and disposition of batches and other post-execution activities.
Summary: The Manufacturing Compliance Coordinator II leads the tracking, coordination, and closure of Manufacturing CAPAs, change controls and deviations, and assists in supporting the timely release and disposition of batches and other post-execution activities.
Summary: The QC Chemist – Raw Materials I, under direct supervision, will be responsible for assisting with raw material sampling, managing quarantine materials and prepare sample shipments for contract laboratory testing. They will also assist with supporting the Quality Control department in the release of all raw materials from the Quarantine Cage/Area for use in Non-GMP and GMP manufacturing activities for NCTM and TBF-100.
Other responsibilities may include but are not limited to: Filing folders, Managing SAP for material accountability at TBF-100 and at NCTM, ordering materials for sampling, coordinating with Materials Management/Warehouse Department on release of components and chemicals, and acquiring BSE/TSE, OAF, USP Class VI statements and/or applicable documents from vendors.
We are seeking a highly motivated individual to join us as a QA Manager in our Contract Manufacturing site located in Research Triangle Park, NC. Primary responsibilities will be to lead the team responsible for supplier qualification and materials release.
Summary The Cell Biology Analyst I, under general direction, will be responsible for performing routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory.
Summary The Cell Biology Analyst II will be responsible for participating in the Technology Transfer of established methods into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
Summary: This position is responsible for the design, development, maintenance, and delivery of technical training for the Manufacturing organization. Prepare training design documents and manage instructional design projects.
Summary: The Quality Control Compliance Manager leads the tracking, coordination, and closure of Quality Control’s CAPAs, change controls and deviations. The successful candidate will also assist the QC department in OOS/OOT investigations. The candidate will ensure all PRs and change controls are closed out in a timely manner.
Summary: The Quality Control Stability Coordinator will be responsible for carrying out supporting activities on the stability program according to current regulations. This includes working with Clients to draft stability protocols, physically setting up stability studies according to respective stability protocols (staging), updating and maintaining stability planning/scheduling tools, ensuring timely execution of stability pulls at each time point, ensuring timely execution of in-house or external testing, writing summary reports, and ensuring the timely delivery of customer-oriented data and documentation.
We are searching for a motivated and hardworking IT professional with Infrastructure knowledge with broad technical knowledge of enterprise classes covering, networking, Security, web technologies, distributed computing and cloud, SAN technologies, database and middleware technologies. This candidate should have experience designing, planning for and deploying application hosting and core data center infrastructure in support of large scale, custom developed applications. Successful candidates will create logical infrastructure designs for complex projects that span the multiple infrastructure technologies.
We are searching for a self-motivated individual to perform general to advanced facility and utility repairs/cosmetic improvements to plant facilities. The Facility Mechanic I will perform routine mechanical troubleshooting and preventive maintenance (PM) tasks.