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. 

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 calls 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.   The QC Supervisor of Drug Product Operations under general direction from the Associate Director, Contamination Control, will be required to oversee all activities involved with Drug Product Quality Operations.  The Supervisor is responsible for Aseptic Process Simulations (APS) and all aspects of the visual inspection program including 100% inspection, AQL inspections, automated inspections, particulate investigations, and identification of required particulates.  The position also requires oversight of all container closure integrity testing activities for component release and final product testing.  These methodologies will also encompass sub-visible particulate testing via USP <787>, USP <788> and USP <789>.  Candidates for this position must have experience in Drug Product visual inspection as well as sub-visible particulates testing in a regulated pharmaceutical and /or biotechnologies setting.  Strong candidates will have a working knowledge of GMP functions and USP guidelines.   Other responsibilities may include but are not limited to staff hiring, supervision, training, discipline and performing annual review assessments; preparing and reporting out monthly metrics for all worked performed within the department; ensuring all equipment is in a state of GMP readiness; writing and reviewing SOPs, verification protocols and reports. 

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.

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.

Are you a global talent professional, experienced in executive global talent search? We present a unique opportunity for someone who shares our passion, drive, and energy - what we call Genki - to join our team!   The Global Talent Partner, Executive Search will own and refine the Executive Global Recruitment process for Global, Business Unit, and Site Roles across the Fujifilm Diosynth Biotechnologies (FDB) network by working in partnership with all FDB sites, Global Leadership Team (GLT)/stakeholders and local Talent Teams to identify and recruit global vacancies.  

The Associate Director, Process Analytics is the system owner for this function, focusing on the drug substance manufacturing at FDBN. This role sets up and maintains informatics systems for process analytics purposes, leads projects to create new process analytics systems, and expands the capabilities and functionalities. This role also supports Process Science for the drug substance group, and ensures the systems support the business processes in place for the site. Additionally, this role creates multivariate models and provides training in the use of process analytics systems that are currently in place

No matter what role you play in FUJIFILM Diosynth Biotechnologies, you are part of a team that is having a profound impact on the lives of countless individuals and families across the globe.  The manufacturing processes that we develop and the medicines that we produce help protect, improve, extend and save lives. We recognize that in order to maximize our impact and ensure the success of our customers and therefore the success of FDB, we need to build a diverse team of individuals that are driven by a passion that we call “Genki.”  Genki is personal, it’s your driving force to learn, grow, strive to do better, and strive to be better knowing that your work truly is positively impacting the lives of countless others around the world.

The QC Lead Associate I position is a position that supports a variety of microbiological disciplines within the Quality Control laboratory. The individual performs laboratory work as assigned to meet production schedules and project milestones and will work with minimal supervision.  The incumbent is expected to follow procedures and gain familiarity with a wide variety of microbiological methods and supporting data management processes.  Microbiological disciplines common to the laboratory include but are not limited to aseptic technique, environmental and clean utility monitoring, bioburden and endotoxin determination, Gram staining, non-host (culture purity) testing, stock culture preparation and maintenance, cell culture maintenance, and associated viral titer assays.  The position primarily works with or may take direction from their manager and more senior department staff, but may work more independently according to the scheduled workload.  Individuals in this role are expected to have proficiency within the assigned disciplines.    Individuals in this role will have primary assigned responsibility for Environmental Monitoring functions or Microbiology support, depending upon department needs and individual capacity.

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. 

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.

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.   *** Please note that this posting represents 2 openings ***   Check out the FDB Holly Springs Site!

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.   Check out the FDB Holly Springs Site!

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.   *** Please note that this posting represents 3 openings ***   Check out the FDB Holly Springs Site!

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.   *** Please note that this posting represents 3 openings ***   Check out the FDB Holly Springs Site!  

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. Check out the FDB Holly Springs Site!

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. *** Please note that this posting represents 4 openings *** Check out the FDB Holly Springs Site!

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 QA Engineer will be responsible to partner in the Quality oversight of IT and Automation (OT) systems through to operational readiness, as well as provide oversight of validation program execution for these systems. You will collaborate within the Digital Technologies (DT) Quality team as well as with other project teams, and with QA departments at other sites with a focus on consistent policy administration, QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.  

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   We are looking for a highly motivated QA Senior Engineer who can work directly with our Quality Leadership team on project and Operational Readiness for QA and QC. In this role you will be a key participant in our journey to establish the largest end-to-end cell culture CDMO facility in North America. The role will focus on coordination of deliverables related to project milestones, driving strategic initiatives together with the whole Quality function, budget oversight as well as executable activities related to the global Quality function.   You have strong communication skills that you use to drive stakeholder alignment through trust and collaboration. Having a strong Quality background, you will get involved in strategic initiatives and once the site is operational this role will have the responsibility of driving operational excellence and continuous improvements initiatives together with the site and Global Quality functions. The role covers supporting all aspects of the Quality unit. You will report to the site Quality Head of QA/QC and Regulatory.   Experience Fujifilm Diosynth Biotechnologies – Holly Springs for yourself! 

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 QC Raw Materials Sr. Analyst 1 is accountable for GMP compliant laboratory operations according to USP/EP/JP regulations.  The role will be responsible for participating in the Technology Transfer of established methods into the FDBN Quality Control Laboratory.  Following Tech-Transfer Activities, the position will be responsible for performing raw material testing and disposition using the established analytical methods.   - Under supervision, support raw material life cycle management (new material assessment, specification establishment, maintenance of specifications etc.) - Supports QC Raw Materials team on internal tech transfer meetings related to new products. - Under supervision and support, authors and reviews procedures, protocols, reports, and specifications related to the raw material area. - Performs testing and disposition of incoming raw materials and components according to specifications and procedures. - Assesses and executes actions related to change controls and vendor change notifications from partners or driven by internal or compendial needs. - Responsible for initiation and execution of Trackwise deviations, CAPA's, lab exceptions and invalid assays - Authors and implements corrective and preventative actions from approved deviations, CAPA's, lab exceptions and invalid assays in Trackwise. - Performs routine investigations in support of out of specification testing results. - Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results. - Enforces established policies and procedures and escalates to management areas where enhancements will improve daily work. - Assists Manager, QC in the implementation of new technologies. - Adheres to pre-defined turnaround times of raw material testing. - Reviews new and updated specifications - Assesses lab exceptions and performs routine investigations. - Utilizes MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated - Performs other duties, as assigned

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.   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 Visual Inspection Analyst II will be responsible for assisting the drug product visual inspection program at FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.