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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.
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 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 Senior Scientist - Downstream Process Development, functions independently and productively in the Downstream Process Development Group actively engaged in process development within a team based PD laboratory. The individual should display strong technical knowledge and scientific understanding of protein purification as well as having experience in process development at both small and large process scales. The individual will provide significant scientific and technical contributions within the Process Development Group.
Summary: The Senior Scientist Upstream will provide technology leadership for the Upstream Process Development for a variety of technical platforms, provide technical support for associated regulatory filings, and improve processes or propose modifications to equipment to deliver improvements. The Senior Scientist will act as technical lead for the development and optimization of novel cell culture and bioreactor processes for multiple viral projects. Responsibilities include cell line selection, process development, process scale-up, and tech transfer. Requires hands-on execution of process optimization, cell culture media, along with process characterization of cell culture production processes that can be transferred to the Manufacturing group as well as external collaborators.
Summary: Our Capital Project team in College Station, Texas is expanding and we are looking for a Project Manager to ensure deliverables for his/her respective projects are well managed and in accordance with their stakeholders and company expectations. The Project Manager will oversee the day-to-day of capital projects from simple scope equipment procurement to more complex scopes involving facility construction/modification, efficiency improvements, systems sustainability and quality/safety enhancement.
The QA Validation Specialist will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, and discrepancies for Quality Assurance. The QA Validation Specialist will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.
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.
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 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 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 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.
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: 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.
Thank you for your interest in FUJIFILM Diosynth. We are always looking for new talent to join our team! Below is the job description for a Program Manager position; should you like to be contacted when we have an opening please submit your resume. Our Talent Acquisition team will review your application and reach out as appropriate.
Our work with a myriad of biopharma companies means each project we work on brings a unique set of challenges. As Program Manager, you are the key link between our customers and our FDB team. You have the uncanny ability to work and build relationships with clients and internal cross-functional teams alike, are an effortless communicator, and can quickly get up to speed on our technology, bringing deep knowledge that will serve as the backbone for the project. You have great EQ, are the most organized person on the team, and are skilled at navigating ambiguity.
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 Process Engineer II is an integral part of the Manufacturing Technical Operations department, supporting Gene Therapy manufacturing at the National Center for Therapeutics Manufacturing (NCTM) and the Flexible Bio-Manufacturing Facility (FBF200), located in College Station, Texas. This position will report directly to the Manager of Technical Operations, Gene Therapy Manufacturing.
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 a variety of gene therapy, protein, and other types of 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 biosafety cabinets and their use in cell propagation, Cell Culture/Single Use Technology for adherent and suspension culture, Dispensing and Mixing and Buffer Preparation, Chromatography, Tangential Flow Filtration, various filtration technologies, cCentrifugation, and Bulk Fill. This position will also create training programs and perform training for manufacturing technicians in the unit operation categories.
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 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.
Join our team of passionate and scientists as we drive cutting-edge biopharmaceuticals from R&D lab to commercialization. Our Senior Process Scientist/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 successful candidate has relevant experience as it relates to the upstream process (Cell Culture, Fermentation, Aseptic technique, Recovery) tech transfer (scale up support, authoring or experience with technical documents, protocols, summary reports, creating BOM, process risk assessment, writing detailed process description), new product introduction through PPQ, process troubleshooting, Change control, deviation support, data analysis, lean six sigma experience, process risk assessment, formulation record, batch record, PPQ document support, inspection support. Technical writing experience, internal cross functional team interaction and client interaction support.