Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Senior Quality Control Specialist will report directly to the Senior Manager, Quality Control at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for Performing routine testing for in-process, intermediates, final product, and stability of clinical and/or commercial lots. They will Act as subject matter expert for analytical methods, troubleshooting, investigations and/or technical reports.

The Staff Automation Engineer is a high-level position in the Automation Engineering department of FDBU. This position will directly report to the Senior Manager of Engineering, but may also have a functional reporting relationship to a senior colleague on a project to project basis.

The QC Associate II 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.   

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Controller will report directly to the Head of Finance at the FUJIFILM Diosynth Biotechnologics California (FDBC) location. The job holder will be responsible for the developing and maintaining accounting systems for financial forecasting and reporting. They will oversee the accounts receivable, accounts payable, and other transactional team members as appropriate.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Senior Specialist, EH&S will report directly to the Senior Manager, EH&S at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will review safety data trends and prepare reports for site, corporate, and external groups. They will be responsible for developing applicant EHS programs to ensure effectiveness and compliance, including new SOP’s and policies.

Fujifilm Diosynth Biotechnologies' Manufacturing group is seeking a Sr. Production Manager. The successful candidate will be recognized as subject matter expert with regard to manufacturing processes and system owner.  They will ensure delivery of production execution schedule and adherence to daily and weekly schedule.  They will initiate and oversee implementation of new technology and modifications to existing technology aimed at cost reduction, efficiency improvements, minimization of downtime and quality/safety enhancement.  Make recommendations regarding departmental profit plan, capital planning, budget and standards development. Recognize and investigate opportunities for financial savings across a broad spectrum of operational activities.  Must be able to identify and communicate improvement opportunities and results. Coordinate and lead production training across shifts.  Identify operational needs for special projects (new product sub-team, capital projects, etc.) ensuring site/divisional linkage is achieved.  Mentor and train new managers and other new departmental employees.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Senior Quality Control Associate will report directly to the Senior Manager, Quality Control at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for performing routine testing for in-process, intermediates, final product, and stability of clinical and/or commercial lots. They will act as subject matter expert for analytical methods, troubleshooting, investigations and/or technical reports.

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. 

Summary:  Works under the supervision of a S&OP Leader or other data governance or analytic leadership appropriate for the scope of work. This supervision may be through a matrixed or direct reporting structure. This role is responsible for data analytics and additional support of performance measures, ongoing measurement, data collection, reporting, data visualizations and information dissemination. Responsible for structuring the strategic design and maintenance of business intelligence applications. Identifies, researches, and resolves technical problems. Ensures that the use of business intelligence applications enhances clinical & business decision making capabilities. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. Engages in data exploration exercises with a variety of complex business intelligence tools, requiring knowledge of relational database structures. Collaborates with other departments.

The Director, Business Development (internally known as Commercial Development Manager) will identify, manage the initial qualification, and close through the signing of a contract for new business, concentrating on Biologics. This candidate will be field-based and located in the Midwest, U.S.

The Senior IT Network Engineer is responsible for the supporting the IT Network Infrastructure for the Biopharmaceutical Manufacturing Operations at FDBU. The role and responsibilities include the design, configuration, implementation, maintenance, security, monitoring and support of both new and existing Network Systems including Switches, Routers, Firewalls, LAN/WAN, WiFi, VPN, supporting the IT Business and Laboratory Environments. This position will work closely alongside members of a Global IT Team including Server Infrastructure Engineers, Application Administrators, and the Desktop Engineering/Service Desk Team.

Summary: The Program Management – Technical Writer, with mentoring and support from the Head of S&OP, will be responsible for drafting the SoWs, Change Orders, and legal letters required by the Program Management, ASG or Saturn Teams, and will manage seamless handover to and from the PM/ASG team member. This role requires an active understanding of the areas of business for which legal documents will be drafted, as well as an active approach to learning the latest best practices across the business, while focusing on the needs of internal customers.

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.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Financial Analyst will report directly to the Head of Finance at the FUJIFILM Diosynth Biotechnologics California (FDBC) location. The job holder will identify financial status and assist in the formulation of internal controls. They will guide cost analysis processes by establishing and enforcing policies and procedures.

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 to be located in Holly Springs, North Carolina, United States.

We are looking for a DeltaV Process Automation Engineerwho 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. In the project phase, your main responsibility as the DeltaV Process Automation Engineerwill be to provide Engineering input on the design and implementation of an Emerson DeltaV control system in the area of Buffer Preparation/Hold, Purification – Chromatography (LPC), Viral Filtration (VF), Ultrafiltration (UF), Diafiltration (DF), and Dispensing. Once in Operations, you will be responsible for and have ownership of the ongoing support of the control system for the defined process areas. You will report to the Automation Lead for DSM.

Summary:  The Regulatory Affairs CMC Associate II is responsible for supporting the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Diosynth partner companies. The primary focus of this position is on moderate to complex regulatory submissions in both eCTD and non-eCTD format. Actual work assignments are based on the FUJIFILM Diosynth portfolio of work along with the incumbent's experience, knowledge, demonstrated technical skills, and competencies, or as part of an individual's development plan.   Regulatory Affairs supports all CMC regulatory affairs activities for FUJIFILM Diosynth partner companies’ products, summarize regulatory intelligence, provides CMC regulatory input for regulatory submissions, and manages the compilation and SME review of CMC sections of all submissions for completeness and quality.

Summary: LDO MX electronic batch record platform will be implemented across FDBK, FDBT and FDBU. The LDO MX Site Business Process Lead will lead the day-to-day management of LDO MX, working in cross functional teams both sitewide and globally.  The Site BP Lead should have a broad knowledge of GMP prep, manufacturing execution and QA activities in relation to batch records, to help make informed decisions.  This position will own the business processes associated with the LDO MX platform, tracking and communication of data and KPIs associated with project goals (reduce disposition time by 50% and GDP errors by 80%).  They will also collaborate with the Master Control MX teams to influence their roadmap; own the LDO SOPs, WIs and eLearning material; and partake in the global LDO committee to promote and ensure alignment across sites.

We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.

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 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.