FUJIFILM

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Search Results Page 4 of 11

Job Locations US-TX-College Station
Posted Date 3 months ago(9/15/2022 9:53 AM)
Summary: This is an experienced person with in depth and specialized knowledge of cGMP documentation.  This position can largely function with minimal or no supervisory oversight for routine duties such as document routing, tracking document review and approval process, assessing document related training requirements and tracking training.  Additionally, they have sufficient knowledge and experience to establish and modify comprehensive document control systems which are compliant with cGMP requirements.  They may be assigned duties representing Quality in appropriate situations as defined by their management. 
Requisition ID
2022-21439
Job Locations US-TX-College Station
Posted Date 3 months ago(9/9/2022 10:10 AM)
Summary:   The Material Transfer Associate is responsible for compiling, organizing and reviewing documents that summarize safety testing results and/or describe safety characteristics of select incoming materials. They are also responsible for performing the material entry evaluation, identify gaps and perform risk analysis when needed to complete the material induction process. In addition, the Material Transfer Associate will be working with internal and external stakeholders to complete the transfer of materials from the client(s) to FDB (Fujifilm Diosynth Biotechnologies) for supporting process development work and cGMP manufacturing activities by monitoring inventory and tracking incoming materials, especially biological materials. 
Requisition ID
2022-21384
Job Locations US-CA-Thousand Oaks
Posted Date 3 months ago(9/8/2022 3:26 PM)
Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Specialist, Process Validation will report directly to the Senior Manager, Technical Services at FUJIFILM Diosynth Biotechnologies. The job holder will be responsible for driving and owning the process and SOP’s for aseptic process verification.
Requisition ID
2022-21377
Job Locations US-CA-Thousand Oaks
Posted Date 3 months ago(9/8/2022 10:26 AM)
Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Quality Control Associate will report directly to the Supervisor, QC Microbiology at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for supporting the routine and non-routine environmental monitoring program. They will participate in the performance of microbiological assays (endotoxin, sterility testing, growth promotion, and purity testing).
Requisition ID
2022-21369
Job Locations US-TX-College Station
Posted Date 3 months ago(9/7/2022 2:37 PM)
Summary: Lead and manage site sales and operations planning process to ensure alignment of functions and senior management to delivery of business goals for medium to long term.
Requisition ID
2022-21363
Job Locations US-TX-College Station
Posted Date 2 months ago(9/21/2022 2:08 PM)
Summary:  Looking for an experienced Financial Analyst in the Bryan/College Station, TX area to support Project Managers and Financial Management with monthly and forecasted revenue and contract reviews.  
Requisition ID
2022-21362
Job Locations US-TX-College Station
Posted Date 3 months ago(9/6/2022 12:45 PM)
Summary: The Quality Assurance (QA) Manager ofAudit &Inspection,will be responsible for the hosting and managing client audits, regulatory inspections and internal audits.  The Manager will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.   
Requisition ID
2022-21346
Job Locations US-NC-Holly Springs
Posted Date 3 months ago(9/16/2022 9:45 AM)
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.   The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.   The Head of Quality Control is responsible for establishing the new Quality Control (QC) laboratories and staffing as well as developing and leading QC laboratory operations at the new Holly Springs site.   As Head of QC, you will have a key role to create and implement the QC strategy for our new facility, collaborating closely with the Holly Springs Head of Quality and our siter site in Denmark to ensure alignment and consistency.  You will be accountable for delivery of all QC programs, projects and laboratory operations, ensuring staff remain on task and execution is aligned with internal/external customer expectations, regulatory expectations and with industry best practices. 
Requisition ID
2022-21325
Job Locations US-TX-College Station
Posted Date 4 months ago(8/19/2022 1:56 PM)
Summary:  The Director of Molecular Analysis will provide expert knowledge in advanced molecular biology based analytical methods and establish at FOB key techniques such as NGS and nanopore sequencing; RNASeq; PCR based methodologies as QC tests and advise FOB on opportunities to expand molecular characterization services.
Requisition ID
2022-21125
Job Locations US-CA-Thousand Oaks
Posted Date 4 months ago(8/17/2022 7:31 PM)
Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Specialist/Senior Specialist, SAP Business Systems will report directly to the Manager, Materials Management at FUJIFILM Diosynth Biotechnologies. The job holder will be responsible for the management of ERP implementation and updates. They will work cross-functionally for successful implementation, evaluation, troubleshooting, and optimization.
Requisition ID
2022-21100
Job Locations US-NC-Research Triangle Park
Posted Date 4 months ago(8/15/2022 3:24 PM)
The Process Sciences Engineer II represents the technical operations department before FDBU customers, regulatory agencies and management. This individual will manage the new client process and ensure project objectives are completed. The Process Scientist/Engineer will also contribute to the technology transfer of multiple projects at various project life-cycle stages (clinical material to commercial supply). Additionally, this individual must possess strong process understanding to implement and execute process risk review and process/cleaning qualification and validation activities. 
Requisition ID
2022-21061
Job Locations US-NC-Research Triangle Park
Posted Date 2 months ago(10/6/2022 2:21 PM)
We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.   The Upstream Process Development group is seeking a Scientist II with experience in microbial and recovery technologies.  A Scientist II independently designs, executes and interprets complex laboratory experiments and development activities with priorities set by supervisor to achieve project goals. The individual demonstrates a practical understanding of own scientific discipline and applies knowledge in support of product development and new technologies. 
Requisition ID
2022-21028
Job Locations US-MA-Boston
Posted Date 4 months ago(8/16/2022 10:18 AM)
The Director, Business Development, Viral Gene Therapy (internally known as Commercial Development Manager) sells FUJIFILM Diosynth Biotechnologies’ VGT services, presenting our technology that has paved the way for the development of gene therapy as a potential long-lasting therapeutic option. You will be selling our ability to provide development, analytical, and manufacturing solutions for viral product needs, including viral vectors for gene therapy and gene-modified cell therapy. You will identify, manage the initial qualification and close through the signing of a letter agreement new business with new customer. This position will be based in Boston, MA.
Requisition ID
2022-21016
Job Locations US-NC-Holly Springs
Posted Date 3 months ago(9/1/2022 2:38 PM)
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 companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki   We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.   The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.   We are looking for a QC Manager- Instrumentation, who wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. But more importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. We offer the possibility of joining our dedicated team with a focus on ensuring QC instrumentation and equipment meet the needs of our new QC Laboratory to support the new cGMP manufacturing facility.   As the QC Manager- Instrumentation, you will be assuring timely and high-quality equipment selection, installation, qualification, service contracts, vendor relations, software (including LIMS) and relevant SOPs to support cGMP operations. You will be reporting initially to the Head of Quality and will eventually report to the Head of QC.  You will join an organization focusing on growth, people, and a steep learning curve as well as a diverse workplace with people driven to make a difference.
Requisition ID
2022-20971
Job Locations US-NC-Holly Springs
Posted Date 1 month ago(11/1/2022 2:40 PM)
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.   Summary: We are looking for an Aseptic Filling/ Formulation Production Process Subject Matter Expert (SME) who holds expertise in the areas of Drug Product Manufacturing, specifically formulation and aseptic filling. Some additional areas of your technical expertise may include manual and automated inspection, device assembly, and/ or label and pack operations. This finished goods experience is a plus. You will own the technical equipment processes and develop operational procedures and detailed design elements for the DP facility, ensuring our successful journey as we establish the largest end-to-end cell culture CDMO facility in North America.  A key area of focus will include supporting and leading the development of the process through coordination with the Manufacturing Sciences and Operational teams. Upon licensure of the Galaxy site, you will be key in leading the operational teams and the liaison between DP Manufacturing and Manufacturing Sciences, and will regularly engage with Senior Leadership, current and future customers, and various regulatory agencies. This is a key role for Fujifilm Diosynth Technologies with a high-level of visibility and expectation; it is also a unique opportunity to take your experience and career to the next level and beyond. The role will initially be reporting to the Head of Building Drug Product and Finished Goods, and ultimately report into the production organization as the project matures and the facility is operational.  As a project SME position, the incumbent’s primary role is supporting the Process Lead, DP-FG.    
Requisition ID
2022-20931
Job Locations US-NC-Research Triangle Park
Posted Date 3 months ago(9/19/2022 10:20 AM)
We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.   The Scientist II independently designs, executes and interprets complex laboratory experiments and development activities with priorities set by supervisor to achieve project goals. The individual demonstrates a practical understanding of own scientific discipline and applies knowledge in support of product development and new technologies  
Requisition ID
2022-20919
Job Locations US-NC-Research Triangle Park
Posted Date 4 months ago(7/27/2022 9:34 AM)
Fujifilm Diosynth Biotechnologies U.S.A., Inc. is seeking a QA Director. The successful candidate is responsible for site Quality Assurance functions and cGMP Compliance. This position manages Quality Assurance staff to develop, implement, administer, and continuously improve quality systems, documentation, and practices. These systems are expected to meet cGMP and corporate quality expectations. The QA Director also manages quality assurance operations support of manufacturing, quality control, analytical development, process development, supply chain, and engineering to meet site business objectives. Quality operations support includes all Quality Assurance functions to facilitate process development, manufacture, and release of APIs throughout the program lifecycle. We are a biotechnology API contract development and manufacturing organization (CDMO) with customer programs from early development through commercial manufacturing. The QA Director must be able to provide quality and compliance leadership utilizing phase appropriate quality standards and cGMPs to meet the dynamic needs of our customer programs.
Requisition ID
2022-20877
Job Locations US-TX-College Station
Posted Date 4 weeks ago(11/9/2022 11:16 AM)
The Work order coordinator, under the supervision of the Facilities Support Operations Supervisor, or designated supervisor will be responsible for performing various aspects of coordination, Work order support for the Texas Biological Facility (TBF), the Flexible Biological Facility (FBF) and the National Center for Therapeutic Manufacturing (NCTM) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). Primary responsibilities include various aspects to support facilities with planning and scheduling equipment for biotech processing equipment. This position will be required to use technical manuals, on-line resources and OEM representatives to maintain the equipment. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory. This position is for day shift.
Requisition ID
2022-20658
Job Locations US-TX-College Station
Posted Date 2 months ago(10/5/2022 11:08 AM)
The Facilities Compliance Coordinator II will be responsible for performing various aspects of  tracking, coordination, and closure of CAPAs, change controls and deviations, and assists in supporting the timely release and disposition of batches and other post-execution activities.  
Requisition ID
2022-20657
Job Locations US-MA-Boston | US-MA-Watertown
Posted Date 5 months ago(6/27/2022 10:55 AM)
Summary: The Assistant Scientist - Process Development is an entry level position for graduates with no prior experience or training. The individual will assist in the development and characterization of customer programs, and technology transfer to the manufacturing and/or Quality control group as appropriate. This individual will be expected to require training on laboratory instrumentation and then use instrumentation to perform elementary lab experiments and document results appropriately.
Requisition ID
2022-20467