Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Manufacturing Associate/Senior Associate will report directly to the Manufacturing Supervisor at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for supporting production in an aseptic environment. They will execute on production batch records and work orders according to SOPs and protocols.  

At Fujifilm Diosynth Biotechnologies (FDB), we are growing our locations and investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States accelerating the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This new site will be the largest end-to-end cell culture CDMO provider in North America offering end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. The new state-of-the-art facility will be located in Holly Springs, North Carolina, United States. At FDB, passion – what we call Genki – lives inside everything we do. It’s within each of our employees, inside our technology, behind our science, manufacturing process and facilities, and central to the accomplishments we help make possible for our customers. It’s the Genki inside FDB uniting us across sites, energizing our work and bringing us toward our shared purpose of advancing tomorrow’s medicines, together. The Internal Communications Lead, Holly Springs will provide communication support for strategic initiatives and operational topics. This individual will support and maintain FDB’s global standards and will develop editorial content for intranet, publications, presentations and other internal communication channels. This role works closely with members of the Corporate Communications Team. This individual ideally has an enterprise mindset and experience with extensive internal and corporate communications, including corporate reputation and employee engagement. This individual understands the strategic value in building evidence through communications for the company's People Strategy, company culture/values, employee experience, learning and other key topics supporting FDB, Holly Springs as an employer of choice. The individual in this position is well versed at translating communications for both internal and external audiences consistent with today's fast-moving digital world.

The work we do at FUJIFILM Diosynth Biotechnologies U.S.A., Inc.  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 FDBU 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 FDBU calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDBU, you determine what’s possible.   As we grow our community, our capacity, and capabilities, we’re looking for passionate people to join our team. Our North Carolina site sits in the renowned Research Triangle Park, the United States’ largest hub of research and innovation. In such a dynamic location adjacent to many of the country’s best places to live, it’s no surprise that our passion is meteoric.   Fujifilm Diosynth Biotechnologies, U.S.A., Inc. is seeking a Production Technician. The successful candidate will execute Development and Production processes as well as the accompanying documentation. 

The Client Support Coordinator will support the Customer Project Management group by escorting Clients to the manufacturing Suites to view their processes. Must be flexible and available to work on nights and weekends.  Varying shifts:  7 am - 3 pm, 3 pm - 11 pm, 11 pm - 7 am.

Fujifilm Diosynth Biotechnologies, U.S.A., Inc. is seeking a Downstream Production Technician to work in our Microbial Manufacturing group. The successful candidate will execute Development and Production processes as well as the accompanying documentation. 

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. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.   Senior Manufacturing Project Lead will act as a manufacturing operations representative supporting the design and construction through to routine production operations.  This individual will ultimately be apart of the campaign life cycle team, supporting change over, column packing, and tech transfer activities.  During the project phase this individual will own or support multiple operational readiness projects.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Specialist, Quality Assurance will report directly to the Senior Manager, QA for Manufacturing at FUJIFILM Diosynth Biotechnologies. The job holder will be responsible for managing batch record review activities. They will work cross-functionally to ensure timely documentation and implementation of effective CAPA’s.

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.   Position Summary   The Head of People and Culture (PnC) will provide strategic support to our senior leaders and managers in the development and implementation of key HR, hiring and recruiting strategies and processes to support overall business objectives. Reporting to the Head of Site, the Head of PnC’s primary responsibility is implementation and oversight of People & Culture strategies and management of day-to-day HR operations and direction in alignment with the business strategy and objectives. This position develops integrated solutions and formulates partnerships across the organization globally in order to deliver value-added services to the leaders of our Holly Springs site.   The ideal candidate has a demonstrated track record of successfully managing end to end People & Culture practices across talent acquisition, performance management, human resource management, workforce planning, communication and ESG. The successful candidate will have experience effectively coaching, guiding and influencing leadership to drive a dynamic, inclusive culture and environment of the company.

We are looking for a Head of Product Supply to join our senior leadership team and help guide our journey to establishing the largest end-to-end cell culture CDMO facility in North America.  As Head of Product Supply, you will lead the Drugs Substance Manufacturing, Drug Product & Finished Goods Manufacturing and Supply Chain groups within the new production facility.  This is a unique opportunity to build something that has never been built before.  You will set the direction for the manufacturing part of a $2B project and play a major role in setting the strategic leadership direction for Fujifilm Diosynth Biotechnologies globally.  You will leverage your experience and knowledge within large-scale manufacturing of biologics, packaging, and supply chain management to create new standards in our organization. 

We are currently seeking an HVAC/Refrigeration Mechanic II/III with primary responsibilities to include corrective and preventative maintenance of HVAC, refrigeration and mechanical equipment and installation and operation of HVAC/Refrigeration equipment.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Senior Scientist/Principal Scientist, Manufacturing Sciences and Technology (MSAT) will report directly to the Director, Manufacturing Science and Technology at the FUJIFILM Diosynth Biotechnologies, California site. The job holder will be responsible for establishing laboratory capabilities, designing, and performing laboratory studies to support process development activities, assessing novel processes and technologies, etc.  They will ensure decisions are made timely and will facilitate active cross-functional technical communication and information flow between internal team members and clients.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California!  The Associate Scientist/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.

No matter what role you play in FUJIFILM Diosynth Biotechnologies (“FDB”), 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 Head of Sales & Operational Planning (S&OP) will lead and manage the Fujifilm Diosytnh Biotechnologies North Carolina RTP site sales and operations planning process to ensure alignment of functions and senior management to delivery of business goals for medium to long term. This role will lead and execute the monthly Sales and Operations Planning (S&OP) activities.  This role will report to the Head of Program Management with strong connections to Strategic Planning, Sales, Manufacturing, and Supply Chain Planning. The purpose of this role is to align production resources across the site to optimize customer service levels, profitability, and resource utilization. This role will be responsible for the alignment of the RTP site’s annual consensus forecast. This role will also develop and implement a Demand Planning capability on the team, a new function at the RTP site.

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 site is located in Holly Springs, North Carolina, United States.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Quality Control Associate will report directly to the Supervisor, QC Microbiology at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for supporting the routine and non-routine environmental monitoring program. They will participate in the performance of microbiological assays (endotoxin, sterility testing, growth promotion, and purity testing).

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.   As we grow our community, our capacity, and capabilities significantly in the next year, we’re looking for passionate people to join our global team. This is a regional position that will support all US sites ( Texas, North Carolina, Boston and California) as well as contributing to the FDB compliance work globally. This position is based at either our North Carolina or Texas site (to be on site a minimum of two days a week).   The Director of Corporate Compliance, US will lead the FDB US Corporate Compliance Team reporting to the Senior Director of Corporate Compliance, Global (Senior Director).  The job holder will assist the Senior Director with the direction of corporate compliance matters for FDB, both independently and in collaboration with their counterpart(s) in Europe and the compliance teams at FUJIFILM Holdings America Corporation (“HLUS”) and FUJIFILM Europe regional headquarters (“FE RHQ”).

The Manager, Downstream is responsible for the planning, directing, and coordinating activities related to the Downstream manufacturing processes at the National Center Therapeutics Manufacturing – NCTM while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics.  The Manager, Downstream will be responsible for the cGMP production and Downstream manufacturing operations.

The Associate Manager, Downstream is responsible for the planning, directing, and coordinating activities related to the Downstream manufacturing processes at the National Center Therapeutics Manufacturing – NCTM while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics.  The Associate Manager, Downstream will be responsible for the cGMP production and Downstream manufacturing operations.

The Validation Manager is the most senior level position within the Validation Team, which is part of the Engineering department of FDBU. The position ensures deliverables for the validation team are well established and in line with business needs and stakeholder expectations. The group consists of 4 – 6 FTE supporting equipment, computer system, and analytical instrument qualification along with oversight of validation contractors.   Reporting directly to the Director of Engineering, the Validation Manager leads the daily activities of the Validation team, including contractors, in support of 24-7 manufacturing operations. In addition, develop and execute efficient validation strategies that meet regulatory requirements and industry standards. Manage all aspects of the site validation lifecycle to assure Facilities, Utilities, Equipment, Instruments and Computerized Systems operate in a state of control consistently and reliably produce products that conform to specifications. Ensure changes in quality and regulatory compliance requirements are identified, documented, integrated, and maintained. Support innovation, continuous improvement, and harmonization of workflows, quality systems, and procedural guidance.   The Validation Manager will directly support or ensure support of capital projects in accordance with FDBU standards and cGMP regulatory requirements.