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Summary: The Quality Assurance - Manager Compliance and Change Control, will be responsible for the leading the compliance team with the management, metrics, and closure of Change Controls. The Manager will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.
Summary: The Quality Assurance (QA) Specialist for Data Integrity will be responsible for the day to day running of the FDBT Data Integrity Program, performing data integrity assessments, gap confirmation and risk assessments, in addition to supporting client and regulatory audits (when required).
Summary: The Quality Assurance (QA) Specialist of compliance, will be responsible for supporting performance of the Quality Systems group. The Specialist will assist with the tracking and coordination and closure of Deviations, Events, Change Controls, and CAPAs.
Summary: The Quality Assurance (QA) Specialist Supplier quality will be responsible for supporting the supplier quality program. The Specialist will assist with ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.
The Downstream Process Development Scientist II functions to design, execute, and interpret 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 will typically lead customer process transfer projects. The individual should display good 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: As part of the Human Resources team, the Human Resources Senior Talent Acquisition Specialist will be responsible for leading the staffing efforts of Fujifilm Diosynth Biotechnologies Texas, LLC (FDBT) and building a strong workforce that adds to the company’s bottom line. This highly skilled Senior Talent Acquisition Specialist should possess knowledge of employment and labor laws, have a deep understanding of the organization, its staffing needs, and possess strong interpersonal and communication skills. The HR Specialist will be expected to find potential candidates, screen, recruit, interview, and recommend the candidate for placement. The Senor Talent Acquisition Specialist must be able to match candidate talents and qualifications for specific jobs in the biotechnology field. The process of recruiting may involve both internal and external sourcing methods, thereby requiring the Senior Talent Acquisition Specialist to be adept at understanding where and how to locate candidates; able to source potential candidates through the local university and through various social media sites (e.g., LinkedIn), job boards, employee referral programs, state employment agencies, recruiting firms, etc.
Summary: The Facilities Engineer II, under the supervision of the Associate Director, Facility Engineering, will be responsible for performing various aspects of engineering, operational and troubleshooting support for facilities, utilities and process equipment including but not limited to bioreactors, fermenters, incubators, filtration skids, chromatography skids, centrifuge, autoclaves, freezers, refrigerators, walk-in cold rooms, QC/PD lab equipment, air cooled chillers, air compressors and dryers, air handling units, MCRs, MBUs, steam boilers, water purification and distillation units, waste water treatment systems, etc. at the National Center for Therapeutic Manufacturing (NCTM), the Texas Biological Facility (TBF) and the Flexible Biological Facility FBF on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). This position will apply engineering principles to monitor the running condition of complex equipment, and use technical manuals, on-line resources and OEM representatives to maintain the equipment with a minimum of downtime. This position will also work closely with manufacturing resources, validation, QA/QC and maintenance/calibration technicians to help maintain complex process equipment operational and troubleshoot to identify issues when needed. This position will require involvement in the utilities and production processes to identify and implement process improvements using Change Control procedures as well as perform corrective and preventive actions using the CAPA system. This position will also support P&ID development, maintenance strategies development, equipment life cycle development, any software and/or hardware upgrades and equipment commissioning/qualification activities as required. This position may also assist in the identification of equipment of the proper type, size, materials, throughput, physical dimensions, required utilities and URS development for future projects.
The Scientist I assists in the planning of, conducting, evaluating, and interpreting routine laboratory experiments. The individual monitors ongoing experiments and identifies and resolves or suggests alternates or solutions to complex occurrences. The individual understands and applies use of equipment, technology and materials associated with analytical development and related studies and projects. The individual takes a more active role in non-routine analytical or process development activities.
Summary: The Manufacturing Technician IV will work directly with a range of technologies. The Technician IV level provides an opportunity to stay on the technical track, or work towards a supervisory path. Dependent upon assignment, the range of technologies.
Summary: The Manufacturing Technician III will work directly with a range of technologies. Dependent upon assignment, the range of technologies.
Spherion Staffing has partnered with FUJIFILM Diosynth Biotechnologies to recruit for the Manufacturing Technician positions. To apply for this position, please apply on Spherion's website by clicking on the follow link: https://www.spherion.com/jobs/manufacturing-technician_college-station_37311934/
Summary: The Manufacturing Technician II work directly with a range of technologies. Dependent upon assignment, the range of technologies.
Summary: The Maintenance Technician II, under the supervision of the Facilities Maintenance Supervisor, or designated supervisor will be responsible for performing various aspects of utilities, facilities and process equipment maintenance, utilities operation and support for the Texas Biological Facility (TBF), the Flexible Biological Facility (FBF) and the National Center for Therapeutic Manufacturing (NCTM) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT).
Primary responsibilities include various aspects of maintenance, utilities operation and support for facilities, utility equipment and biotech processing equipment.
This position will be required to use technical manuals, on-line resources and OEM representatives to maintain the equipment operational with a minimum of downtime. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory.
Summary: The Senior Scientist – Analytical Method Transfer (AMT) will function collaboratively and productively in a team devoted to ensuring the quality of effective analytical methods at FDBT. The individual should possess broad scientific knowledge of bioanalytical techniques that are used to assess viruses and proteins as well as strong technical writing skills.
The AMT group is a protocol-driven group which will primarily perform Tech Transfer, Qualification, and Validation of test methods coming out of the FDB analytical groups and transition them into our Quality Control group. The position will predominately focus on creating analytical method protocols and summary reports, executing protocols, reviewing data, ensuring a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success, troubleshooting issues/spearheading investigations and working closely with the QA group and client. The candidate will be expected to follow cGMP documentation practices.
Summary: The Upstream Process Development Scientist II is responsible for driving the development of new cell culture and fermentation processes at laboratory-scale, manufacturing-scale, technical transfers of client processes into Process Development or Manufacturing, and technical transfers from Process Development to Manufacturing. Projects include, but are not limited to, cell and virus culture, cell banking, fed batch as well as perfusion bioreactor processing, and in-process testing. The individual should display strong technical knowledge and scientific understanding of cell culture, expansion, harvest, medium development, clone selection and development, and DOE studies, as well as having experience in process development with both small and large process scales. The individual may lead a project and assist in multiple projects. The individual is expected to provide strong scientific and technical contributions within the Process Development Group and will work closely with other Departments to develop strong working relationships.
Summary: Fujifilm Diosynth Biotechnologies, Texas, Inc. is offering part time work (10-20 hours per week) for college students majoring in Life Sciences or preferably Biological Sciences. We offer a supportive, collaborative teaching environment to develop our student worker’s skills and identify their career goals. This is a great opportunity to gain invaluable experience working for an industry-leading biopharmaceutical contract manufacturing organization. The student worker will work in direct contact with the department staff to assist with department specific duties as requested. The duration of the position will be determined between the supervisor, and Human Resources.
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 analytical and/or virology, and applies knowledge in support of product development and new technologies. The individual should display strong technical knowledge and scientific understanding of the development of analytical and/or virology assays, and DOE studies. The individual may lead a project and assist in multiple projects. The individual is expected to provide strong scientific and technical contributions within the Process Development Group and will work closely with other Departments to develop strong working relationships
Summary:The Sr. Manufacturing Process Engineer is a mid-level position in the Manufacturing Technology Operations department in support of either the SATURN mAb or Gene Therapy manufacturing facilities located at the Texas BioManufacturing Facility – 100 (TBF – 100) or the Flexible Biomanufacturing Facility - 200 (FBF-200) respectively in College Station, Texas. The SATURN Platform utilizes entirely single use technology and is a multi-stream, multi-product facility that manufactures clinical and commercial products. The Gene Therapy operations at FBF-200 also utilizes single use technology in support of COVID-19 vaccine candidate manufacturing.
As a CDMO, customer liaison is a vital part of our business and the Technical Operations team act as the point of contact for our customers during manufacturing execution. This position will report directly to the Manager, Technical Operations, but may also have a functional reporting relationship to a senior colleague on a project-to-project basis.
The Sr. Manufacturing Process Engineer works independently, with minimal supervision, and leads projects and colleagues to provide expertise and assistance for the design, development, standardization and maintenance of operational biotechnology utilized in the manufacture of proteins and drug substances. This person will be the subject matter expert on core manufacturing and operational technologies for the manufacturing unit. Operational biotechnologies include: Isolators and their use in cell propagation, Cell Culture/Single Use Technology, Filtration, Chromatography and Final Filtration. Core manufacturing technologies include Weigh and Dispensing and Mixing and Buffer Preparation.
The Program Coordinator II, with minimal supervision, will support site business planning and customer projects by maintaining relevant databases and liaising with Program Directors.
Summary: The Supply Chain Planner is responsible for the planning and execution of materials in support of FDBT GMP projects as per the S&OP asset plan via the site ERP/ SAP system. The Supply Chain Planner will convert the requirements ofthe Process Consumable List after handoff of the required materials and catalog numbers from Process Science. The Supply Chain Planner will create the Bill of Materials, Material Masters and Project Recipes in SAP. In order to create Work in Progress (WIP), The Supply Chain Planner will via SAP, convert planned orders into process orders for material picking in the GMP warehouses. The Planner is required to have the right materials, released and available at the correct time to the correct specification to support the Master Schedule. Materials planning will be conducted via SAP following MRP planning principles. The Supply Chain Planner will work with the Process Development, Process Science, Manufacturing,Quality groups and other areas of Supply Chain to ensure the identification of materials meets the Compliance and Quality requirements for the facilities.
Summary: The Manufacturing Readiness Coordinator II assists the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones.