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Job Locations US-NC-Holly Springs
Posted Date 5 days ago(1/26/2023 3:13 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.    Join us    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.    Supplier quality management begins early in the product design and supplier selection process. It continues through the entire life cycle of a product or service and for the duration of the relationship with that particular supplier.     This position provides supplier oversight to ensure that suppliers of services or materials to FDB are of the highest quality while conforming to pre-established requirementsincluding cGMP’s.    The primary responsibilities will focus on supplier quality, working with suppliers to maintain supplier approvals.  Initially, this position will be key to the establishment of the Supplier Quality System including but not limited to SOP and Specification development, Quality Agreements, Risk Assessments, Supplier Auditing and Supplier Change Notifications. The ability to effectively collaborate, influence, and coordinate amongst suppliers and team members within Supply Chain, Quality Control and Quality Management is critical to this role. 
Requisition ID
2023-22616
Job Locations US-NC-Holly Springs
Posted Date 5 days ago(1/26/2023 2:31 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.   Join us    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.   About:  The Program Quality Manager (PQM) is accountable for programs from the point of Quality Agreement signature through program closure. The PQM ensures FDBN provide services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance).   The Program Quality Manager, PQMis the primary client liaison representing FDBN. The PQM typically handles an average load of 2-4 programs and receives coaching & guidance from the Director, QA.   
Requisition ID
2023-22614
Job Locations US-NC-Holly Springs
Posted Date 6 days ago(1/25/2023 2:27 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   Join us   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 Quality Assurance Engineer, Digital Technologies, who wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. More importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. As the QA Engineer for Digital Technologies, you will have direct impact on the validation of a fully automated $2 billion Greenfield CDMO facility. In the project phase, your main responsibility as the QA Engineer SME for Digital Technologies will be to help drive the Quality oversight for the direction of all automated GxP Manufacturing and IT Computerized Systems as well as oversight of validation documentation for these systems. You will work closely together with other areas within the project, as well as IT/Automation departments at other sites to align strategies and procedures.   Once in operations, you will assist the Quality partnership in ensuring that all GxP Manufacturing and IT Computerized Systems are maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. Additionally, you will participate in improvement initiatives and support regulatory agency and third-party inspections.   You will report to the QA Lead Engineer for Digital Technologies.  
Requisition ID
2023-22604
Job Locations US-CA-Thousand Oaks
Posted Date 7 days ago(1/24/2023 4:11 PM)
Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Manufacturing Technician will report directly to the Senior Manager, Manufacturing at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for contributing to the successful delivery of released product in support of clinical and commercial processes.  
Requisition ID
2023-22601
Job Locations US-NC-Holly Springs
Posted Date 1 week ago(1/23/2023 9:24 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. Join us 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 Senior IT System Manager who wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. More importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. In the project phase, your main responsibility will be to liaise with Global IT teams to stand up the IT systems needed to operate the facility. The IT systems will be needed at different phases during the project you will be working with different functional groups to ensure that the systems are ready in due time for their purposes. We are looking for a passionate person that will initially be involved within the CMMS area and will advise and coach on the best industry practices to help us to implement our Infor CMMS system. Additional systems will fall under your responsibility as the projects are initiated. You will function as a local extension of the Global IT team reporting into the Project Head of IT.
Requisition ID
2023-22589
Job Locations US-TX-College Station
Posted Date 1 week ago(1/23/2023 6:13 PM)
Summary:     The Scientist II for Molecular Analysis will provide bioinformatics and analytic support to multiple projects in biopharmaceutical development at FDB sites. The job holder will require expert knowledge in the analysis of advanced molecular biology assays developed at FDBT focused on next-generation sequencing (Illumina, Oxford Nanopore) datasets and assist in expanding FDBT molecular characterization services.
Requisition ID
2023-22586
Job Locations US-MA-Boston | US-MA-Boston
Posted Date 1 week ago(1/23/2023 10:04 AM)
Summary:  The Upstream Internship offered at Fujifilm Diosynth Biotechnologies, Watertown MA. is designed to provide a supportive, collaborative teaching environment for successful candidates who are in their sophomore year or higher. Our goal is to develop our Interns' skills and abilities, while identifying their career goals.  The Intern will work in direct contact with the department staff to assist with department specific duties as requested.  Internships generally run from mid-May to August but may vary.  The dates will be determined between the intern, supervisor, and Human Resources.
Requisition ID
2023-22580
Job Locations US-TX-College Station
Posted Date 2 weeks ago(1/20/2023 5:25 PM)
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)   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 create 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 FDB call Genki.   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.
Requisition ID
2023-22577
Job Locations US-TX-College Station
Posted Date 2 weeks ago(1/20/2023 5:22 PM)
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)   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 create 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 FDB call Genki.   Summary:  The Biotechnology Process Sciences Technician I functions within a team based organization to actively address cGMP manufacturing requirements.  The individual’s main responsibility is to obtain documentation for cGMP appropriate materials (raw materials and components), prepare item specifications for these materials and track the completion of the specification paperwork.  The individual will also assist with other cGMP pre-production activities such as the selection of cGMP appropriate materials and equipment as directed.   This individual must work in a collaborative manner to assist the transfer of biological drug processes from process development (internal or client) groups in a CDMO environment.
Requisition ID
2023-22576
Job Locations US-TX-College Station
Posted Date 2 weeks ago(1/20/2023 5:20 PM)
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)   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 create 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 FDB call Genki.   Summary The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations.  This individual will supervise a team of employees directly or indirectly in these production process units.
Requisition ID
2023-22575
Job Locations US-TX-College Station
Posted Date 2 weeks ago(1/20/2023 5:17 PM)
    Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)   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 create 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 FDB call Genki.   Summary: The Quality Assurance - Manager Compliance and Change Control, will be responsible for the leading the compliance team with the management, metrics, and closure of Change Controls.  The Manager will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance. 
Requisition ID
2023-22574
Job Locations US-TX-College Station
Posted Date 2 weeks ago(1/20/2023 12:45 PM)
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)   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 create 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 FDB call Genki.   Summary:  Under supervision of the Site Head, the Site Services Supervisor will be responsible for the overall support of the Boston facilities including facility operation & maintenance, asset management, equipment maintenance & calibration, materials management, and shipping/receiving.  This position will work closely with supporting groups at FDBT and with contractors to perform these functions. The first phase Boston facility is an 8000 sq.ft. space that consists of Process Development & Analytical Development laboratories with a capacity of up to 6 client programs per year.  The second phase Boston facility is a 36,000 sq.ft. space that will be operational in 2023 and will consist of Process Development, Analytical Development, and clinical GMP manufacturing with a capacity of up to 15 programs per year.  The phase 2 facility is on the same campus as the phase 1 facility.
Requisition ID
2023-22560
Job Locations US-MA-Boston | US-MA-Boston
Posted Date 2 weeks ago(1/20/2023 12:30 PM)
Summary: The Associate Principal Scientist, under minimal supervision, will develop new methods to support clients and adapt client-specific methods to FDBT instrumentation as well as helping to qualify and/or validate them. This role will be expected to perform as the subject matter expert (SME) and provide technical leadership to the team in most aspects of the laboratory.
Requisition ID
2023-22559
Job Locations US-TX-College Station
Posted Date 2 weeks ago(1/20/2023 12:22 PM)
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)   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 create 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 FDB call Genki.   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.  
Requisition ID
2023-22558
Job Locations US-NC-Holly Springs
Posted Date 2 weeks ago(1/20/2023 9:19 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.   We currently seeking a Human Resources Business Partner to join our growing Human Resources team.  The HR Business Partner will play a vital role in ensuring employee satisfaction, engagement and retention through the development and implementation of policies and practices.  Strong leadership skills coupled with empathy and appropriate firmness is required for success.  The ability to deliver transparent crucial conversations to all levels of the organization and effectively coach and develop team members is critical.    We are searching for an individual with strong leadership skills coupled with empathy and appropriate firmness.  The ability to engage in transparent and crucial conversations with all levels of the organization and effectively coach and develop team members is critical.   The Senior HR Business Partner will help drive HR programs that focus on our most important asset – our people.  In this highly visible role, you will have the opportunity to work with an amazing, robust, and agile People and Culture team responsible for supporting our newest site in Holly Springs as well as enter into global partnerships and collaborations with our sister sites across the globe. The successful candidate will be a motivated self-starter who values quality, change-management, and collaboration.  The successful candidate will have a natural sense of urgency & drive, as well asthe ability to work with people at all levels of an organization with a “Genki” and customer service-oriented mindset.
Requisition ID
2023-22554
Job Locations US-NC-Holly Springs
Posted Date 2 weeks ago(1/18/2023 5:03 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 currently seeking a Recruiting Coordinator to serve as a key part of our People and Culture team.  As a part of this group, you will schedule candidate interviews, assist with onboarding, and help drive HR programs that focus on our most important asset – our people.  In this highly visible role, you will have the opportunity to work with an amazing, robust, and agile team responsible for supporting our newest site in Holly Springs. The successful candidate will be a motivated self-starter who values innovation, change-management, and collaboration.
Requisition ID
2023-22546
Job Locations US-NC-Holly Springs
Posted Date 2 weeks ago(1/17/2023 3:08 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.   Join us 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 Computer Systems Validation (CSV) Engineer is responsible for supporting compliance related to computerized systems via the creation, review, and execution of validation documentation and protocols for IT systems with applicable regulatory and cGMP guidelines.   The CSV Engineer will provide IT systems validation and compliance expertise for the various systems across the new site. This position will work within a collaborative team and will be required to have excellent verbal and written communication skills.   This position requires basic knowledge of IT infrastructure hardware, software, and FDA regulation 21 CFR Part 11.   This position will report directly to the Project Head – Information Technology but may also have a functional reporting relationship to a senior colleague on a project-to-project basis.
Requisition ID
2023-22530
Job Locations US-CA-Thousand Oaks
Posted Date 2 weeks ago(1/17/2023 10:27 AM)
Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Senior Accountant will report directly to the Head of Finance at FUJIFILM Diosynth Biotechnologies. The job holder will be responsible for developing and maintaining accounting systems. They will forecast revenue, calculate and entry of month end journals, guide cost analysis, as well as oversee accounts receivable and accounts payable.
Requisition ID
2023-22528
Job Locations US-CA-Thousand Oaks
Posted Date 2 weeks ago(1/17/2023 10:19 AM)
Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California!  The Scientist, Process Sciences will report directly to the Senior Director, Manufacturing Science and Technology at the FUJIFILM Diosynth Biotechnologies, California site.  The job holder will be responsible for designing and performing laboratory activities to support process development and process characterization of client cell therapy processes and products.  He/she will be responsible for cell processing, process scale-up/scale-down, bioreactor process parameters, cryopreservation, and equipment evaluation.
Requisition ID
2023-22527
Job Locations US-TX-College Station
Posted Date 2 weeks ago(1/16/2023 11:22 AM)
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)   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 create 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 FDB call Genki.   Summary: The Technical Writer II for Manufacturing Support will be primarily responsible for drafting formulation records and supporting documents for execution of manufacturing campaigns to support client needs.  Additionally, this role will be responsible for the creation and revision of Standard Operating Procedures, Work Instructions/training material and any relevant technical documentation to support manufacturing activities. This role requires an understanding of cGMP production, a strong proficiency in Microsoft Office functions, Document Management systems, as well as an active approach to learning the latest best practices across the business and applying them to documents.
Requisition ID
2023-22518