Summary   The Sample Management Analyst I, under general direction, will be responsible for performing routine and non-routine support of samples submitted to the Quality Control (QC) Laboratory for evaluation. This position works as part of the Sample Management team to manage the receipt, organization and inventory of samples from manufacturing, clients, other Fujifilm facilities and third parties. The Sample Management Analyst I arrange sample shipments for outsource testing and shipments to Clients or other facilities and controls dispensing of samples for QC testing.   

The Quality Assurance (QA) Associate Manager of Audit & Inspection, will be responsible for the hosting and managing client audits, regulatory inspections, internal audits, and supplier assurance.  The Associate Manager will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance. 

The work we do at FujiFilm Diosynth Biotechnologies (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.   Video:  Experience Fujifilm Diosynth Biotechnologies – Holly Springs for yourself!   We are looking for a dedicated, result-oriented Senior Process Engineer I to join our Process Engineering team with a focus on upstream process equipment. As a Senior Engineer I, you will own the engineering responsibilities for the assigned equipment, deliver equipment packages on time and within budget, and work with CQV and the turnover team to ensure the equipment is ready for the first process.  As the site moves into operations circa 2025, this position is planned for transition to a Process Engineering role in upstream.  We are looking for someone with positive energy, entrepreneurship and courage to empower and inspire others. You will join an organization focusing on growth, a steep learning curve and most importantly a focus on people and what you can bring to the table.

  Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Inventory Associate will report directly to the Senior Materials Management Manager at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for developing and implementing procedures for ensuring that adequate inventory levels are present. They will perform verification checks on stored inventory and discard inventory that does not meet the company’s standards.

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.

Overview Section: 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: This role will be the Quality organization's Subject Matter Expert (SME) as it relates to the LIMS configuration, implementation, analysis as well as the maintenance in FDBT facilities.

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 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 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 Quality Control Chemist II, with limited supervision, will be responsible for participating in the Technology Transfer of established methods into the FUJIFILM Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.  Following Tech-Transfer Activities, the candidate will be responsible for performing release and stability testing using the established analytical methods.

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 Technician IV will work directly with a range of technologies. The Technician IV level provides an opportunity to stay on the technical track, or work towards a supervisory path. Dependent upon assignment, the range of technologies may include any of the following:

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 Technician III will work directly with a range of technologies. Dependent upon assignment, the range of technologies exposed to will be:

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 Microbiology Analyst II will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FUJIFILM Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. 

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 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, Drug Substance Manufacturing (DSM), 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 DSM, you will directly impact the validation and start-up of a fully automated $2 billion Greenfield CDMO facility. During the project phase, the QA Engineer for DSM will be responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes through to operational readiness, as well as provide oversight of validation program execution for these processes. You will collaborate with other project teams, and with QA departments at other sites to align strategies and procedures.   Once in operations, you will continue to ensure that all DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration, QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation. Additionally, you will participate in optimization or improvement initiatives and support regulatory agency and third-party inspections.   You will report to the QA Manager for DSM.  

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.

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.

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.

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.

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 Sr. Quality Assurance Engineer, Drug Product, 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 Sr. QA Engineer DP, you will directly impact the validation and start-up of a fully automated $2 billion Greenfield CDMO facility. During the project phase, the Sr. QA Engineer for DP will be responsible to help drive the Quality oversight for the direction of all Drug Product Manufacturing processes through to operational readiness, as well as provide oversight of validation program execution for these processes. You will collaborate with other project teams, and with QA departments at other sites to align strategies and procedures.   Once in operations, you will continue to ensure that all DP systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration, QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation. Additionally, you will participate in optimization or improvement initiatives and support regulatory agency and third-party inspections.   You will report to the QA Lead Engineer for Drug Product/Finished Goods.

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:  Senior member of the Fujifilm Diosynth Biotechnologies (FDBT) team responsible for  Employee Health & Safety and Sustainability & ESG (Environmental, Social, and Governance) programs to ensure compliance with applicable local, state, and federal ordinances regarding safety programs, health, environmental plans, as well as ensuring industry standards are attained.   The Associate Director will also be responsible for defining and developing comprehensive and effective plans to ensure FDBT delivers on Sustainability & ESG while collaborating and coordinating across functions and local communities on resolving environmental and social issues.  Lead the strategic development ad continual enhancement of Employee Health & Safety initiatives as well as enterprise ESG goals and initiatives that aim to strengthen risk mitigation and create long-term business value for the company. The Associate Director will be responsible for managing all Environmental, Health, and Safety programs as well as ensuring industry standards are attained.  The Associate Director will also be responsible for convening internal ESG conversations to drive corporate ESG strategy and produce recommendations on actions, policy, or behavior changes by working with internal stakeholders to enact these recommendations and develop a cohesive narrative around them. The FDBT facilities are modern biotech manufacturing facilities with analytical labs, product, and process development labs as well as vaccine and protein/antibody manufacturing and purification labs.  The successful candidate will be required to build and maintain strong relationships and leverage existing experience from strategic and tactical roles in large organizations, projects, and/or operations to guide cross-functional team members on the journey.