Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Specialist/Senior Specialist, Quality Control will report directly to the Head of Quality Control at the FUJIFILM Diosynth Biotechnologics California (FDBC) location. The job holder will be responsible for investigating deviation events for Quality Control Laboratories. They will own, review and approve investigation reports to address nonconforming events.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Quality Assurance Specialist/Senior Specialist will report directly to the Director, Qualty Operations at the FUJIFILM Diosynth Biotechnologies Caiifornia (FDBC) location.  The job holder will be responsbile for understanding regulatory requirements related to QC system and Data.  They will collaborate and lead discussions with other managers to ensure deliverables meet the needs across the organization.    

The Process Sciences Engineer II (Downstream) 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 Process Engineer II will have downstream purification process skills such as tangential flow filtration, general filtration, chromatography purification and recipe development/execution/evaluation using Unicorn®

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Senior Specialist - Manufacturing will report directly to the Manufacturing Manager at the FUJIFILM Diosynth Biotechnologics California (FDBC) location. The job holder will be responsible for ensuring successful identification and implementation of applicable contamination controls. They will investigate and document details of deviation events that occur during the manufacture of FDB products.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Director/Senior Director, Quality Control will report directly to the Head of Quality Control at the FUJIFILM Diosynth Biotechnologics California (FDBC) location. The job holder will be responsible for leading and developing a team in alignment with Quality Control's objectives. They will develop phase-appropriate QC capabilities, business processes and procedures..  

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Specialist/Senior Specialist Quality Control will report directly to the Head of Quality Control at the FUJIFILM Diosynth Biotechnologics California (FDBC) location. The job holder will be responsible for the investigation of deviation events for Quality Control Laboratories. They will own, review and approve investigation reports to address noncomforming events.

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.

Summary:  The Purchasing & Planning Manager is responsible for the operations of GMP Purchasing and Supply Chain Planning at Fujifilm Texas to ensure that the right materials are available at the right time, in the correct quantity to support GMP production. This role will oversee the materials planning process and direct purchasing while liaising with both internal and external stakeholders on the status of material readiness. The full life cycle of material management will also include the running of the ERP SAP system using MRP. Within SAP, Bill of Material creation, planned demand and conversion to process orders (WIP) will be the responsibility of the Supply Chain teams. The Purchasing & Planning Manager will provide SME over site to these processes as well as managing the Supply Chain teams on a longer strategic planning horizon.

The Director, Strategic Planning is responsible for building and leading a new site planning function. This position will lead the site and our functional departments through mid and long term planning and delivery and leverage S&OP processes to deliver a consensus driven demand plan that optimizes the balance between market capability and supply capability.  The ideal candidate will be a strong and collaborative people leader who can work cross functionally.  This role will assess our pharmaceutical site capability in terms of production, and work with sales to create informed decision making for revenue generating activities to supplement the site’s production suites, spacing and resource capability.  This role will also lead the strategic oversight of program materials required for the longer term basis, and then partner with supply chain procurement for leveraging orders/planning.

Summary:  As part of the Human Resources team, the Talent Acquisition Specialist will be responsible for supporting the staffing efforts of Fujifilm Diosynth Biotechnologies Texas, LLC (FDBT) and building a strong technical workforce that adds to the company’s bottom line. This highly skilled technical recruiting professional should possess knowledge of employment and labor law, have a deep understanding of the organization and its staffing needs, and possess strong interpersonal and communication skills. The Talent Acquisition Specialist must be able to match candidate talents and qualifications for specific jobs in the biotechnology field by screening them and recommend them for placement. The process of recruiting may involve both internal and external sourcing methods, thereby requiring the Talent Acquisition Specialist to be adept at understanding where and how to locate candidates.

Summary:  The Information Technology Quality Engineer serves as the IT Administrator for Quality and/or Laboratory Information Systems.

The Manufacturing Lead will oversee and perform cGMP manufacturing operations for manufactured biopharmaceutical products.  Ensure the effective use of material, equipment, and personnel while making products at high quality levels. Recognized as a subject matter expert with regard to manufacturing processes.

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

The QC Scientist I is responsible for independent problem solving and the individual is specialized in at one or more discipline area within the department. The primary responsibility is to execute components of a project, both internal method improvement projects and larger customer technology/method transfer and qualification projects with the objective of revenue, profit plan, and manufacturing schedule attainment. The QC Scientist I supports the project management and quality systems related to the routine testing and technology transfer. The Scientist may have a lead role in method development and transfer projects from the customer to the QC laboratory. The incumbent represents the department as a discipline or technology subject matter expert, assisting with the development, trouble-shooting, improvement, and implementation of analytical methodology into the group. The individual interacts with all levels and departments within the company, assuring procedures, protocols, and project plans are suitable for implementation, that they meet the regulatory and customer requirements, and that they have continuity with existing processes and procedures.

Summary: The Downstream Process Development Associate Scientist functions to assist in the planning and execution of complex laboratory experiments and activities necessary for gene therapy, vaccine, and recombinant protein purification process development with priorities set by supervisor/project lead to achieve project goals. The individual typically provides technical support for GMP activities and represents the Downstream Process Development group during process transfer and manufacturing support. This individual will have familiarity with a range of purification technologies including centrifugation, filtration technologies (TFF and depth), chromatographic separations and basic laboratory analytical techniques (SDS-PAGE, spectroscopy, pH/conductivity meters, etc.)

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 Senior Cleaning Validation Engineer is a high-level position in the MT&S department of FDBU. In this position you will provide on the floor support developing automation methods, working directly with clients, working with chromatography/filtration systems and acting as the Subject matter expert for the role. 

The Manufacturing Facility Associate is responsible for activities associated with facility related job task for the manufacturing group. Authoring and ownership of deviations, change control and change over from a technical aspect. Complete support for the right first-time execution of manufacturing per locked schedule and support of the timely release and disposition of batches.  

Summary:  The Downstream Process Development Scientist I functions to assist in the planning of, execution, and interpretation of complex laboratory experiments and activities necessary for gene therapy, vaccine, and recombinant protein purification process development with priorities set by supervisor/project lead to achieve project goals. The individual may lead small customer or internal projects, and typically oversees the daily activities within ongoing projects under guidance of the project lead. The individual should display technical knowledge and scientific understanding of downstream purification of viruses, proteins, and plasmid DNA as well as having knowledge of process development at both small and large process scales.

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.