The Process Sciences Engineer II represents the technical operations department before FDBU customers, regulatory agencies and management. This individual will manage the new client process and ensure project objectives are completed. The Process Scientist/Engineer will also contribute to the technology transfer of multiple projects at various project life-cycle stages (clinical material to commercial supply). Additionally, this individual must possess strong process understanding to implement and execute process risk review and process/cleaning qualification and validation activities. 

The Downstream Process Development group at FDBU group is seeking an Associate Scientist at our Bioprocess Innovation Center in Research Triangle Park, NC. The successful candidate’s primary responsibility is the execution and documentation of scientific experiments and maintaining laboratory equipment. The position assists scientific staff in conducting and reporting the results of laboratory experiments. The individual monitors ongoing experiments for any unusual occurrences. The individual will develop a practical understanding of own scientific discipline and apply this knowledge in support of product development.

The QC Lead Associate I 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 will work with moderate supervision. They are expected to follow procedures and have/gain familiarity with a wide variety of analytical methods and supporting data management processes. The individual effectively and efficiently manages more complex or difficult tasks. Analytical disciplines common to the laboratory include, but are not limited to: Chromatography, HPLC, Concentration determination, pH, Total Organic Carbon, Gel based protein separation, EF, Plate Based Assay, and conductivity. The position primarily works with or may take from peers within the department, but may work more independently according to the scheduled workload. Individuals in this role are expected to have or build proficiency within the assigned disciplines. Experience in a GMP facility is required.  

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Associate Director, New Product Introductions will report directly to the Director, Manufacturing Science and Technology at FUJIFILM Diosynth Biotechnologies. The job holder will be responsible for leading the New Product Introduction team in day-to-day operations They will ensure that new programs are onboarded successfully.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Manager, Quality Control, Bioanalytical will report directly to the Associate Director, Quality Control at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for managing Quality Control activities at FDBC's QC Bioanalytical labs, including raw materials, in-process, stability, and product release testing.  They will lead and develop a team of QC Associates/Sr Associates in alignment with FDBS's and department objectives.

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. 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.  

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Supervisor Quality Control will report directly to the Associate Director, Quality Control at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for managing and scheduling Quality Control activities at QC Bioanalytical laboratories including cell culture, in-process, stability and product release testing. They will lead and develop a team of QC Associates/Sr Associates in alignment with department objectives.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Director, Quality Systems and Compliance report directly to the Director, Quality at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for Quality Systems and Compliance. They will lead the Quality Systems and Compliance Team.

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.   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 Site & Facility Service/Office Coordinator, who will join our journey to establish the largest end-to-end cell culture CDMO facility in North America. You will support the Facilities Manager in various aspects including, but not limited to various administrative duties and assist People & Culture with onboarding. You will be responsible for creating a dynamic experience for the staff on the Galaxy Project. As Site & Facility Service/Office Coordinator, you will be responsible for managing the site and supporting the facilities manager in a $2 billion global project.   We are looking for a Site & Facility Service/Office Coordinatorthat is passionate about what they do and driven to get it done. You will join an organization focusing on growth, people and a learning curve as well as a diverse workplace with others driven to make a difference.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Senior Manager, Document Management will report directly to the Director, Quality Management Systems and Compliance at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for management of the Document Management process and team. They will maintain and implement policies and procedures regarding document creation, revision, and obsoletion.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The QA Specialist, GMP Learning and Development will report directly to the Director, Quality Systems and Compliance at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for developing and updating documents to support programs and system requirements. They will assist with curriculum development, as well as design and delivery of GMP and onboarding training for GMP staff.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The QA Associate, Document Management will report directly to the Senior Manager, Document Management at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for scanning and management documents for electronic storage. They will support document workflows in the system as a Document Coordinator.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Quality Assurance Specialist will report directly to the Manager, Quality Operations at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for evaluating compliance issues, providing recommendations, and assuring progress of quality records to completion . They will perform and support routine quality audits in Manufacturing.

The QC Lead Associate I will support a broad range of analytical disciplines within the Quality Control laboratory. This position will perform testing in the QC Analytical Chemistry laboratory. The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with minimal supervision. They are expected to follow procedures and have familiarity and proficiency with a wide variety of analytical methods and supporting data management processes. The individual effectively and efficiently manages complex or difficult tasks. 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, but may work more independently according to the scheduled workload. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter expert.

The QA Manager is responsible for specific quality and compliance areas within Quality Assurance for a site. Manage Quality Assurance systems and staff to meet site quality and compliance expectations.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Specialist, Process Validation will report directly to the Senior Manager, Technical Services at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for driving aseptic process verifications (media simulations). They will own business process and standard operating procedure(s) for aseptic process verifications.

Summary: The Assistant Scientist - Process Development is an entry level position for graduates with no prior experience or training. The individual will assist in the development and characterization of customer programs, and technology transfer to the manufacturing and/or Quality control group as appropriate. This individual will be expected to require training on laboratory instrumentation and then use instrumentation to perform elementary lab experiments and document results appropriately.

The QC Lead Associate I 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 will work with moderate supervision. They are expected to follow procedures and have/gain familiarity with a wide variety of analytical methods and supporting data management processes. The individual effectively and efficiently manages more complex or difficult tasks. Analytical disciplines common to the laboratory include, but are not limited to: Chromatography, HPLC, Concentration determination, pH, Total Organic Carbon, Gel based protein separation, EF, Plate Based Assay, and conductivity. The position primarily works with or may take from peers within the department, but may work more independently according to the scheduled workload. Individuals in this role are expected to have or build proficiency within the assigned disciplines. Experience in a GMP facility is required.  

The QC Lead Associate I will support a broad range of analytical disciplines within the Quality Control laboratory. This position will perform testing in the QC Analytical Chemistry laboratory. The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with minimal supervision. They are expected to follow procedures and have familiarity and proficiency with a wide variety of analytical methods and supporting data management processes. The individual effectively and efficiently manages complex or difficult tasks. 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, but may work more independently according to the scheduled workload. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter expert. This position is 2nd shift Sunday-Wednesday 2:00pm-12:00am.

The QC Lead Associate I 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 will work with moderate supervision. They are expected to follow procedures and have/gain familiarity with a wide variety of analytical methods and supporting data management processes. The individual effectively and efficiently manages more complex or difficult tasks. Analytical disciplines common to the laboratory include, but are not limited to: Chromatography, HPLC, Concentration determination, pH, Total Organic Carbon, Gel based protein separation, EF, Plate Based Assay, and conductivity. The position primarily works with or may take from peers within the department, but may work more independently according to the scheduled workload. Individuals in this role are expected to have or build proficiency within the assigned disciplines. The ideal candidate has experience providing test support in biochemistry and experience with gel and plate based disciplines. Experience in a GMP facility is required.