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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: 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.
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: 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 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.
The Director, Business Development - Gene Therapy (internally known as Commercial Development Manager) will identify, manage the initial qualification, and close through the signing of a letter of agreement for new business.
This is a global position that will support all four sites (FDBU, FDBT, FDBK, and FDBD) but will sit on the West Coast and report into FDBU.
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.
The Staff Validation Engineer is a high-level position in the Validation department of FDBU. This position will directly report to the Associate Director of Manufacturing Technology and Support, but may also have a functional reporting relationship to a senior colleague on a project to project basis.
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.
The QA Manager for Product Release and Operations is responsible for specific quality and compliance areas within Quality Assurance for a site. They will manage Quality Assurance systems and staff to meet site quality and compliance expectations. Other responsibilities include being a customer liaison, acting as the project compliance lead for manufacturing readiness (including process validation programs), being the Quality SME during customer audits and health authority inspections, and quality oversight for batch record review, deviation review and closure, managing customer requirements, and final product quality decisions.
Summary: The Information Technology Lab Engineer serves as the IT support for Quality and/or Laboratory Information Systems.
Support the Quality Assurance (QA) Informatics program by using Visual Basic to develop and support data metrics trackers and KPI templates in various software platforms.
Summary: The Microbiology Analyst I will be responsible for assisting the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
FUJIFILM Diosynth Biotechnologies is searching for a junior or senior Automation engineer to support Bioprocess operations at their NC site. The primary purpose of this position is to provide diagnostics/troubleshooting support for the manufacturing, development, and facilities process control and monitoring systems with some focus on implementing new process automation technology in Bioprocessing industry.
Summary: The Manufacturing Readiness Coordinator 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.
FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (FDBU) is seeking a Process Engineer within the Engineering department. The successful candidate will support capital and operational projects with equipment design, commissioning, FAT/SAT testing and installation. Working with the other functions within engineering, the position will ensure deliverables for his/her respective projects are well managed and in line with their stakeholders expectations. FDBU Engineering consists of project, process, automation, and lab analytical responsible for both capital and operational projects in support of manufacturing, process development, and facilities/maintenance.
The Master Scheduler is responsible for the maintenance of the Production Plan in the ERP system to support the MRP (Material Requirement Planning) process. Responsible for providing the Supply Chain team with a monthly production plan consistent with the asset / production plan and forecasted demands. New business opportunities, customer expectations, internal supply requests, and internal supply constraints will be used to load the production plan in ERP system for a defined period. Strong collaboration with Operations and Supply will be critical to meeting the business objectives.
The Analytical Method Transfer group is seeking an Associate Scientist with protein chemistry experience. The AMT group is a technologically diverse group that primarily performs formal Tech Transfer, Qualification, Validation and Verification of test methods coming out of the development group and then transitions them into our Quality Control group. This high performing group is the interface between the development and quality groups and is responsible for ensuring long term success of the methods entering into QC.