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.  

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.

Join FUJIFILM Diosynth Biotechnologies (FDB) in our new facility location - Thousand Oaks, California (FDBC)! The IT Business Analyst, Quality Management Systems (QMS) will serve as a liaison between business and technology to assist or gather business requirements needed for the Quality Management Systems (QMS). This person will be the subject matter expert and lead for all applications for the Quality department and report to the IT Applications Lead. In addition, this person will lead multiple initiatives for these systems in alignment with the Global FDB IT organization.

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 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.

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 Quality Control Cell Biology Supervisor will be responsible for coordinating the installation and qualification of new analytical equipment in support of GMP release and stability testing.  The Cell Biology/Immunology Supervisor will lead tech transfer activities of qualified cell based and immunological methods from designated donor laboratories.  The Supervisor will play a pivotal role in selecting qualified personnel to staff the QC Cell Biology laboratory.  

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Quality Control Senior 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 planning and implementing the design, configuration and/or customization of LIMS according to business requirements . They will lead optimization of LIMS activities in collaboration with functional areas, which include defining LIMS workflows, maintain dynamic/static data in LIMS, perform and participate in GMP review, LIMS Access review and internal/external audits.

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 Validation Project Manager will be responsible for managing the execution of multiple Computer Systems validation (CSV) and Data Integrity (DI) related projects at FDBT facilities. Support the Director of Validation by ensuring effective implementation and maintenance of the CSV and DI program. Serve as a CSV subject matter expert, and track and report action plan status/ completion as relates to CSV/DI validation systems improvement efforts.

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:  Fujifilm Diosynth Biotechnologies, Texas, Inc. is offering temporary work opportunities (20 hours per week) for current students who have completed their sophmore year in Life Sciences or related fields.  We offer a supportive, collaborative environment that encourages development of necessary skills, identify, and attain career goals.  This is a great opportunity to gain invaluable experience working for an industry-leading biopharmaceutical contract manufacturing organization.  The position offers prospects of working experienced scientific personnel on key projects.  The duration of the position can be discussed with the supervisor and Human Resources. The temporary position also offers possibilities of translating into a full-time position within Fujifilm Diosynth.

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 QC Stability Coordinator III, will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data.  The Quality Control Coordinator III, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry, Cell Biology, Microbiology, and Quality Assurance groups to coordinate execution of testing, deviation management, and issuance of deliverables. The Coordinator will have visibility to method qualification to ensure timing of stability laydowns. Close attention to detail is required to oversee and compile the stability testing and data, to facilitate meeting deadlines and milestones. Other responsibilities may include but are not limited to: ownership of CAPA’s and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software.

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 QC Stability Coordinator II will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data.  The Quality Control Coordinator II, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry, Cell Biology, Microbiology, and Quality Assurance groups to coordinate execution of testing, deviation management, and issuance of deliverables. The Coordinator will have visibility to method qualification to ensure timing of stability laydowns. Close attention to detail is required to oversee and compile the stability testing and data, to facilitate meeting deadlines and milestones. Other responsibilities may include but are not limited to: ownership of CAPA’s and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software.

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 QC Stability Coordinator I, will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data.  The Quality Control Coordinator I, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry, Cell Biology, Microbiology, and Quality Assurance groups to coordinate execution of testing, deviation management, and issuance of deliverables. The Coordinator will have visibility to method qualification to ensure timing of stability laydowns. Close attention to detail is required to oversee scheduling the stability testing and compiling data, to facilitate meeting deadlines and milestones. Other responsibilities may include but are not limited to: ownership of CAPA’s and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software.

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 QC Stability Coordinator III, will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data.  The Quality Control Coordinator III, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry, Cell Biology, Microbiology, and Quality Assurance groups to coordinate execution of testing, deviation management, and issuance of deliverables. The Coordinator will have visibility to method qualification to ensure timing of stability laydowns. Close attention to detail is required to oversee and compile the stability testing and data, to facilitate meeting deadlines and milestones. Other responsibilities may include but are not limited to: ownership of CAPA’s and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software.

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 remote and should be located in the eastern US. 

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 Microbiology IV will demonstrate a strong technical background and be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.

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 Quality Assurance (QA) Risk Management Manager position will be responsible for providing leadership to the Texas site in ICH Q9 principles of Risk Management.  Ability to facilitate risk assessments, train future facilitators, provide oversight and tracking of remediation actions, and communicate to leadership on the status.

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: FUJIFILM Diosynth Biotechnologies Texas is seeking a dynamic and dedicated MSATPrincipal Scientist to fulfill the leadership role of the Process Characterization (PC) Unit as part of the Process Development team at the College Station, Texas site. This person will lead a growing team of talented scientists and work directly with counterparts within the FDB global organization to deliver on an expanding globally harmonized PC business model. The PC laboratories will include state of the art instrumentation to support late-stage process characterization activities for biopharmaceutical programs for external sponsors. It is preferred to find a candidate with exposure to upstream, downstream, and analytical biopharmaceutical development and process characterization.   (Relocation assistance provided)

Summary: The Quality Assurance – Sr. Compliance Specialist, will be responsible for supporting performance of the Quality Systems group.  The Specialist will assist with the tracking and coordination and closure Change Control records, investigations, and all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.   

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 Quality Assurance (QA) Analyst, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally. They will also provide daily guidance, work prioritization and support to other departments, such as manufacturing or QC, in absence of or in conjunction with their manager.

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 Readiness Coordinator I assist the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones. 

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 Operations – Technical Writer will be responsible for drafting batch records for execution of manufacturing campaigns to support client needs.  Additionally, this role will be responsible for the creation and revision of PCL’s, procedures and protocols to support manufacturing activities. This role requires an understanding of GMP production, a strong proficiency in Microsoft Office functions, as well as an active approach to learning the latest best practices across the business.