Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.  The QC Associate Operations position is responsible for executing sample management activities, which include control, receipt, and distribution of product, intermediates, raw materials samples, sample retention, reference samples, and stability samples at Fujifilm Diosynth Biotechnologies California (FDBC).  The QC Associate Operations position will interact regularly with internal QC, Quality Assurance, Manufacturing, Warehouse and Facilities groups.  In addition to external Quality representatives supporting client requests and/or notifications.

Summary:  The Quality Assurance (QA) SpecialistSupplier quality will be responsible forsupportingthe supplier quality program.  The Specialistwill assist with ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility. 

We are very excited to launch our internship program at FDB in Thousand Oaks! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.  The Intern will support the New Product Introduction Team helping ensure successful new product introductions. They will support in the planning & delivery of projects from the point of project scoping through project closure. The Intern will serve as a project lead and is responsible for ensuring successful identification and introduction of a new project at the FDBC facility via facilitation of cross functional teams, driving schedule adherence, escalation of identified risk, and any other activities that may serve to support our site.

Summary:  Under direct supervision, the Materials Management Specialist I is responsible for supporting receiving, ordering, shipping, general warehousing, and internal distribution of cGMP (current Good Manufacturing Practices) and non-GMP materials in support of company operations. *This is an overnight position.  Working hours are Midnight-8am.

Summary:  The Supply Chain Planner is responsible for the planning and execution of materials in support of FDBT GMP projects as per the S&OP asset plan via the site ERP/ SAP system. The Supply Chain Planner will convert the requirements of the Process Consumable List after handoff of the required materials and catalog numbers from Process Science.  The Supply Chain Planner will create the Bill of Materials, Material Masters and Project Recipes in SAP.  In order to create Work in Progress (WIP), The Supply Chain Planner will via SAP, convert planned orders into process orders for material picking in the GMP warehouses. The Planner is required to have the right materials, released and available at the correct time to the correct specification to support the Master Schedule. Materials planning will be conducted via SAP following MRP planning principles. The Supply Chain Planner will work with the Process Development, Process Science, Manufacturing, Quality groups and other areas of Supply Chain to ensure the identification of materials meets the Compliance and Quality requirements for the facilities.

Summary:  The Supply Chain Planner II is responsible for the planning and execution of materials in support of FDBT GMP projects as per the S&OP asset plan via the site ERP/ SAP system. The Supply Chain Planner II will convert the requirements of the Process Consumable List after handoff of the required materials and catalog numbers from Process Science.  The Supply Chain Planner II will create the Bill of Materials, Material Masters and Project Recipes in SAP.  In order to create Work in Progress (WIP), The Supply Chain Planner will via SAP, convert planned orders into process orders for material picking in the GMP warehouses. The Planner is required to have the right materials, released and available at the correct time to the correct specification to support the Master Schedule. Materials planning will be conducted via SAP following MRP planning principles. The Supply Chain Planner II will work with the Process Development, Process Science, Manufacturing, Quality groups and other areas of Supply Chain to ensure the identification of materials meets the Compliance and Quality requirements for the facilities.

Summary:  The GMP Buyer will be responsible for the converting of SAP requisitions to purchase orders for direct materials to support GMP production activities. As part of this role, the GMP Buyer will manage the Quality approved vendor base, using Vendor Relationship Management (VRM), manage and lead vendor Quality Business Reviews (QBR) and the associated KPI’s. Each buyer will have the responsibility of being the Point Of Contact for nominated key vendors. The GMP Buyers will maintain the Material Masters and associated info records and source lists within SAP ensuring lead time data is accurate and up to date and all pricing of materials is agreed by Fujifilm Purchasing before being entered into SAP. 

Summary:  The Compliance Coordinator I is responsible for supporting deviation investigations, Change Controls, CAPA management to ensure accurate, thorough, and on time completion.  The incumbent applies systematic and analytical root cause analysis techniques inclusive of Human and Organizational Performance principles to each investigation.

As a member of the Supply Chain organization, the Master Data Coordinator is responsible for the creation and maintenance of item master material to support Fujifilm Diosynth Biotechnologies supply chain operations, ensuring business continuity, and accurate data quality. They will collaborate with business, operations, and technology stakeholders to utilize processes and workflows to build a strong data foundation for supply chain. Pioneer master data governance best practices with a focus in continuous improvement to promote growth and structure for daily supply chain operations. The Master Data Coordinator will also be adaptable to assisting with business or IT projects to advise on master data topics and execute necessary activities.   The Master Data Coordinator is a hybrid position with a required minimum of 3 days per week on-site, or more as required. This position is also required to be on call 1 weekend per month.

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. 

We at FDBC are excited to offer a part time internship opportunity for Spring 2024!  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 our new FDB facility in Thousand Oaks, CA and help manufacture the next cell 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.  The Supplier Quality Intern will support the Supplier Quality Team helping ensure a successful supplier quality program. This individual will contribute to supplier qualification and supplier monitoring activities for the site to improve compliance. The supplier quality intern would also be exposed to other quality areas and would help with cross functional needs.

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO 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 This Role   The Sr. IT Application Specialist is responsible for operations and maintenance of the local BI & Analytics systems as the single point of contact and escalation for the locally used systems.  The role and responsibilities will also evolve as the project group expands

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 our new FDB facility in Thousand Oaks, CA and help manufacture the next cell 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. The Environmental Support Technician works as part of the manufacturing team to deliver high quality therapeutics.  This position contributes to the successful delivery of released product in support of clinical and commercial processes.

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO 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.

Summary:  The CAD & Engineering Document Management Specialist, under the supervision of the Director of Engineering, will be responsible to proactively develop the computer aided design function and properly define the engineering document management strategy for the College Station site. Perform routine to moderately complex design and drafting functions in support of various areas such as engineering, manufacturing, facilities, validation, etc. Perform various aspects of maintaining the engineering drawings, blueprints, P&IDs, technical manuals and other documents related to the equipment and facilities of FDBT, both hard copy and electronic.      Responsibilities include verification of existing equipment and facilities documents in cooperation with contractors,engineers and validation personnel, and tracking the changes made to those documents under authorized engineering change control. This will include facilities drawings, OEM and Vendor drawings, and producing revisions to such drawings. This will also include drafting preliminary changes to such drawings for approvals, as well as tracking drawings which are out-of-date and no longer accurate or obsolete.This position will also be responsible for working with engineers and equipment providers ofutilities and equipment OEMs for up-to-date versions for turnover.      Primarily be responsible forFDBT facilities and equipment documentation but the role may include GMP facilities and equipment not wholly owned by FDBT and will require liaison with engineers or document control personnel of other contractors and institutions.  This position will also work closely with other technicians and engineers who need access to the most recent documentation, such as Validation and Quality personnel.   

Summary:  The Engineering Coordinator, under the supervision of the Director of Engineering, will be responsible for performingengineering coordination activitieson behalf of the different facilities at Fujifilm Diosynth Biotechnology Texas (FDBT)and the projects implementation under the engineering department responsibility. These activities include but are not limited to tracking and review projects and engineering documentation, coordinating construction activities and/or equipment installations, coordinating with impacted areas for activities implementation, performingasset inductions, support work order generation and documentation and preparing project updates, status and/or metrics. This position will work closely with project/process engineers, CAPEX team, manufacturing resources, validation and contractors to help coordinate engineering activities in support of project’s implementation and/or utility/process equipment complex operational issues. This position will also supportP&ID development/redlining,and maintenance strategies development. 

- Summary:  The Quality Assurance (QA) - Compliance Specialist I for Audit & Inspection will be responsible for supporting all associated audit responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance, including  supporting client audits, regulatory inspections, and conducting internal and supplier audits.

Fujifilm Diosynth Biotechnologies is searching for a Quality Control Specialist to join our growing team in Thousand Oaks, CA. The Quality Control Specialist is an individual contributor responsible for driving analytical implementation at the Quality Control Laboratories. The role requires strong technical expertise, communication, leadership, and project management skills. The candidate must have strong GMP laboratory skills, bioassay, cell biology or immunology experience.  Position requires a self-motivated, detailed oriented, and flexible expert, able to prioritize, multi-task, and work in a fast-paced & demanding environment.  

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.    College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.   Summary:The Manufacturing Process Engineer I/II is an integral part of the Manufacturing Technical Operations department located in College Station, Texas.  This position will report directly to the Manager of Technical Operations, Manufacturing.   Works independently and with colleagues to provide expertise and assistance for the design, development, standardization, and maintenance of an operational biotechnology utilized to manufacture various proteins and other drug substances.  This person would provide manufacturing technical support on core manufacturing and operational technologies for the manufacturing unit.  Operational biotechnologies include 1. USP: Isolators and biosafety cabinets and their use in cell propagation, Cell Culture/Single Use Technology for adherent and suspension culture; 2. DSP: Dispensing and Mixing and Buffer Preparation, Chromatography, Tangential Flow Filtration, various filtration technologies, centrifugation, and Bulk Fill.  This position will also create training programs and perform training for manufacturing technicians in the unit operation categories.

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 our new FDB facility in Thousand Oaks, CA and help manufacture the next cell 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.   Position Summary The Sr. Material Scientist is a critical leadership position, serving as a subject matter expert (SME) responsible for the successful evaluation, recommendation, and onboarding of new raw materials and single use components that will be used for production of external partner products and processes.  Supporting programs from project scoping/technology transfer activities through execution of GMP production and on-going production support efforts.