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Search results were sorted by Posted Date in descending order

Search Results Page 1 of 13

Job Locations US-NC-Research Triangle Park
Posted Date 13 hours ago(5/15/2022 9:18 PM)
The QA Supervisor, Document Control will manage a group of 4-7 document control associates as they process tasks within MasterControl and other systems, such as LIMS.  In addition, this supervisor will oversee record issuance document archival in compliance with site SOPs. The successful candidate will be comfortable working in a fast-paced environment and is flexible, dependable and has the ability to lead a team while also managing work on needed quality assurance tasks.
Requisition ID
2022-20101
Job Locations US-NC-Research Triangle Park | US-NC-Holly Springs | US-TX-College Station | US-MA-Boston | US-CA-Thousand Oaks
Posted Date 16 hours ago(5/15/2022 6:02 PM)
The Executive Director of Commercial Development for Advanced Therapies will co-develop and maintain FDB Advanced Therapy Sales and Marketing strategies aligned with FDB budget and growth plans and implement sales strategies in the North American Territory.
Requisition ID
2022-20077
Job Locations US-NC-Holly Springs
Posted Date 4 days ago(5/12/2022 6:19 PM)
We are searching for a Process Support equipment engineer that will ensure that the cleaning, steaming, and ancillary process equipment deliverables from Fujifilm and from EPCM provider are timely and in the required quality. You will act as driver of the process equipment activities and must be able to, proactively, facilitate cross organizational interaction with external EPCM providers and use your extensive experience from a similar role in large pharma/biotech projects.   We are looking for someone with positive energy, entrepreneurship, and courage to empower and inspire others. You will join an organization with focus on growth, you will have a steep learning curve but most essential there is a focus on people first and what you can bring to the table. We have a diverse workplace for people driven to make a difference.
Requisition ID
2021-16397
Job Locations US-NC-Research Triangle Park
Posted Date 4 days ago(5/12/2022 5:29 PM)
Competent operation professional responsible for performing tasks at predefined levels within projects or operations.  Tasks may be routine in nature, expertise generally limited to areas of responsibility.  Understands the “why” part of the job.  Demonstrates knowledge of internal customers and support area requirements.  
Requisition ID
2022-20084
Job Locations US-NC-Research Triangle Park
Posted Date 4 days ago(5/12/2022 3:45 PM)
The Business Analyst is responsible for providing advanced support for IT applications used within the Biopharmaceutical Manufacturing Operations in North America. Support is provided in person, or via, Teams, Zoom, phone, email and ServiceNow. The Business Analyst will assist Manufacturing Operations to determine the best way to use IT applications to improve and adapt to changing business needs.
Requisition ID
2022-20082
Job Locations US-NC-Research Triangle Park
Posted Date 4 days ago(5/12/2022 3:19 PM)
The Manager, QC- Data Review will be responsible for managing the data review of Analytical, Biochemistry, Microbiology and Raw Material testing and report issuance within the cGMP Quality Control laboratories.  The Data Review Manager will be responsible to manage a team of analysts focused on the technical and compliance review of STAT, release and stability testing in support of biotechnology manufacturing. The Data Review Manager must have great attention to detail, be able to work independently, and have, or develop, a thorough technical knowledge of the techniques being reviewed. The Data Review Manager has accountability for exceptions associated with the execution of data review (deviations, CAPAs, OOS, OOT) and be expected to manage each to timely closure in partnership with technical product leads, the clients and Quality Assurance.    The performance of the team is measured against milestones established on a monthly basis to support the business needs, ownership of the testing and review milestones resides with the QC management team. The position is expected to work with peers in Quality Control, Quality Assurance, Analytical Method Technology and Analytical Development to ensure testing turnaround times are met and in accordance with cGMP expectations.  The department’s core responsibilities are centered on providing manufacturing support for STAT in-process assays, raw material testing, stability testing of drug substance and client drug product samples, release testing and supplemental (protocol based) testing. A core responsibility of the QC Data Review Manager is ensuring the development of the staff through the creation and delivery of data review training.  It is the expectation that a culture of quality ownership and accountability is fostered at all levels within the laboratory setting. 
Requisition ID
2022-20081
Job Locations US-CA-Thousand Oaks
Posted Date 4 days ago(5/12/2022 2:54 PM)
The Senior Director of Engineering, Facilities, and EHS is a member of the Site Leadership team and has responsibility for ensuring the FDBC facility, equipment, and automation systems are designed, installed, and maintained to meet the operational, compliance, and safety needs of the site. The Senior Director leads the Plant and Project Engineering, Facilities, and EHS and functions for the site.
Requisition ID
2022-20080
Job Locations US-TX-College Station
Posted Date 4 days ago(5/12/2022 2:12 PM)
Summary:   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 analytical and/or virology, and applies knowledge in support of product development and new technologies. The individual should display strong technical knowledge and scientific understanding of the development of analytical and/or virology assays, and DOE studies. The individual may lead a project and assist in multiple projects. The individual is expected to provide strong scientific and technical contributions within the Process Development Group and will work closely with other Departments to develop strong working relationships
Requisition ID
2021-14933
Job Locations US-NC-Holly Springs
Posted Date 5 days ago(5/11/2022 2:38 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.   The Upstream Operations Manufacturing Project Lead acts as the upstream operations representative supporting the design and construction through to routine production operations.  This individual will have some responsibility to hire, lead, and inspire manufacturing associates and supervisors during the project and into operations.
Requisition ID
2022-20066
Job Locations US-NC-Research Triangle Park
Posted Date 5 days ago(5/11/2022 1:49 PM)
  The QC Data Coordinator will assist the Quality Control department with organizing paper and electronic records, reconciliation and tracking of documents and data in an organized manner within the department and labs, in binders, cabinets and/or online folders, and tracking the location administratively.  This position will help support the team with photocopying, scanning and completing sets of documents critical for pharmaceutical product release and stability and requires a keen attention to detail and willingness to support a variety of teams and employees within the department.  
Requisition ID
2022-20065
Job Locations US-NC-Research Triangle Park
Posted Date 6 days ago(5/10/2022 5:01 PM)
Primary responsibilities of the QC Technical Supervisor will be to test complex and critical analytical chemistry/biochemistry assays (50% of time) and to supervise and coordinate staff performing analytical chemistry testing and the associated laboratories (50% of time) in support of processes and products manufactured at the RTP site. This individual will provide technical leadership to staff to support routine testing including HPLC, UPLC, SEC, CE, iCiEF, Peptide Mapping, DNA Threshold testing, pH, Appearance, Western Blot, ELISA, HCP and other biochemistry and analytical chemistry tests. The role will be a primary contact for the Quality Control laboratory, collaborating with staff outside of the department, facilitating timely and right first-time data management and reporting, and assuring testing is completed in support of manufacturing timelines.
Requisition ID
2022-20059
Job Locations US-TX-College Station
Posted Date 6 days ago(5/10/2022 1:53 PM)
Summary:  The Program Manager, with mentoring and support from the Head of Program Management and/or Associate Program Director or Program Director, will be responsible for the planning and delivery of programs from the point of contract signature (Scope of Work/Letter of Intent/Contract) to program delivery including technology transfer and taking a product/process from execution of a client commercial agreement or memorandum of understanding through process development and early stage clinical supply through program closure.  The Program Manager ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission (strategy and compliance).  The Program manager typically manages programs of shorter duration and/or fewer concurrent programs relative to a Associate Program Director.  
Requisition ID
2021-16630
Job Locations US-NC-Holly Springs
Posted Date 6 days ago(5/10/2022 1:09 PM)
The Head of Process Science will establish and lead our Manufacturing Science, Program Management & Tech Transfer interfaces to drug development partners at our Holly Springs site.  This senior leader will be essential in driving our new customer base as well as ensuring complete end-to-end Process Development and Manufacturing Science as Drug Product capabilities are being built to form an entire Process Science team.  They will function as the key overall customer interface for new products, processes and changes from partners and programs.  All strategic, tactical and operational aspects of the group will support the bulk drug substances and ensure close collaboration with Manufacturing, Global Engineering & Facilities, Quality, Regulatory, CMC, Business Development and Tech Development in meeting the business objectives.  The Head of Process Science will collaborate closely with our Denmark location to ensure alignment across key areas and will have full accountability for adherence to cGMP requirements and regulations.
Requisition ID
2022-20054
Job Locations US-NC-Research Triangle Park
Posted Date 6 days ago(5/10/2022 12:54 PM)
The QC Lead Associate I position is a position that supports a variety of analytical disciplines within the Quality Control laboratory. The individual performs laboratory work as assigned to meet production schedules and project milestones and will work with moderate supervision. They are expected to follow procedures and have/gain familiarity with a wide variety of analytical methods and supporting data management processes. The individual effectively and efficiently manages more complex or difficult tasks. Analytical disciplines common to the laboratory include, but are not limited to: Chromatography, HPLC, Concentration determination, pH, Total Organic Carbon, Gel based protein separation, EF, Plate Based Assay, and conductivity. The position primarily works with or may take from peers within the department, but may work more independently according to the scheduled workload. Individuals in this role are expected to have or build proficiency within the assigned disciplines. Experience in a GMP facility is required.
Requisition ID
2022-20053
Job Locations US-NC-Research Triangle Park
Posted Date 6 days ago(5/10/2022 12:47 PM)
The QC Lead Associate, Data Reviewer position is a position that supports a broad range of analytical disciplines within the Quality Control laboratory. The individual performs data review for testing of high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with minimal supervision. They are expected to follow procedures and have familiarity and proficiency with a wide variety of analytical methods and supporting data management processes. The individual effectively and efficiently manages complex or difficult tasks. Analytical disciplines requiring data review common to the laboratory include, but are not limited to: Chromatography, HPLC, Concentration determination, pH, Total Organic Carbon, Gel based protein separation, IEF, Plate Based Assay, and conductivity.
Requisition ID
2022-20052
Job Locations US-NC-Research Triangle Park
Posted Date 6 days ago(5/10/2022 12:39 PM)
The Bioassay Development group is seeking a Scientist II with experience in cell-based assays, ELISAs and Plate-based testing. 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. The Scientist II has broad experience in cell-based assays, ELISAs and Plate-based testing. The successful candidate will primarily be responsible for the development and qualification of assays for the characterization and identity, purity, and strength assessment of recombinant protein drugs.
Requisition ID
2022-20051
Job Locations US-NC-Research Triangle Park
Posted Date 6 days ago(5/10/2022 11:57 AM)
The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We’re 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. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.   The QC Associate II, 2nd shift position is a position that supports a variety of analytical disciplines within the Quality Control laboratory. The individual performs laboratory work as assigned to meet production schedules and project milestones and works within clearly defined routine processes. They are expected to follow procedures and have/gain familiarity with a wide variety of analytical methods and supporting data management processes. Analytical disciplines common to the laboratory include, but are not limited to: Chromatography, HPLC, Concentration determination, pH, Total Organic Carbon, Gel based protein separation, IEF, Plate Based Assay, and conductivity. The position primarily works with or may take direction from peers within the department. Individuals in this role are expected to have or quickly gain familiarity and build competency within the assigned disciplines.
Requisition ID
2022-20050
Job Locations US-NC-Research Triangle Park
Posted Date 6 days ago(5/10/2022 11:52 AM)
The QC Lead Associate II will support a broad range of analytical disciplines within the Quality Control laboratory. This position will perform testing in the QC Analytical Chemistry laboratory. The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with minimal supervision. They are expected to follow procedures and have familiarity and proficiency with a wide variety of analytical methods and supporting data management processes. The individual effectively and efficiently manages complex or difficult tasks. Analytical disciplines common to the laboratory include, but are not limited to: Chromatography, HPLC, Concentration determination, pH, Total Organic Carbon, Gel based protein separation, IEF, Plate Based Assay, and conductivity. The position primarily works with or may take direction from peers within the department, but may work more independently according to the scheduled workload. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter experts.
Requisition ID
2022-20049
Job Locations US-TX-College Station
Posted Date 6 days ago(5/10/2022 11:26 AM)
Summary:  The Process Engineer II- DP Manufacturing is an integral part of the Drug Product Manufacturing Operations department, located in College Station, Texas.  This position will report directly to the Manager, DP Manufacturing.   Works independently, and with colleagues, to provide expertise and assistance in the drug product operations, including and not limited to support a flawless process execution, assisting in the writing, reviewing and approvals of change controls, deviations and CAPAS. The Engineering will be responsible to keep and maintain all equipment of the area in the operation and compliance state.   The position will focus on the resolution, improvements and enhancements of current operations which employs, Filling Isolator Technology for the aseptic filling for multiples projects. This role will also support the visual inspection process and collaborates with multiples departments to have a final DP unit, in syringes or vial presentation, complying with the quality and client standards.   This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit.  This position will also create training programs and perform training for manufacturing technicians in the unit operation categories.   The process Engineering II maybe leading/supervising others process engineering I and related technical positions for the DP team.  
Requisition ID
2022-20048
Job Locations US-TX-College Station
Posted Date 7 days ago(5/9/2022 6:25 PM)
Summary:  The Manager, Manufacturing Compliance Coordination (FBF) is responsible for all manufacturing CAPAs, change controls and deviations. This includes the leading of all manufacturing deviation investigations through to completion, support of all internal and external audits and collaboration with cross functional groups including Quality Assurance to support ‘on-time’ release and disposition of batches and other post-execution activities.
Requisition ID
2021-18365