Summary: As part of the Human Resources team, the Office Manager/ HR Assistant provides overall day-to-day administrative  support to the facility as well as supporting other departments requiring general administrative duties and HR responsibilities. The HR Assistant/Office Manager will be responsible for supporting the staffing efforts of Fujifilm Diosynth Biotechnologies Massachusetts (FDBM) and building a strong workforce that adds to the company’s bottom line. This skilled HR/Administrative professional should possess knowledge of HR functions and have a deep understanding of the organization and its staffing needs, and possess strong interpersonal and communication skills. Any and all administrative duties that support Human Resources and other departments. 

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 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.  

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:  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.

Summary:   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.

  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. 

Summary: The QC Chemist – Raw Materials I, under direct supervision, will be responsible for assisting with raw material sampling, managing quarantine materials and prepare sample shipments for contract laboratory testing. They will also assist with supporting the Quality Control department in the release of all raw materials from the Quarantine Cage/Area for use in Non-GMP and GMP manufacturing activities for NCTM and TBF-100.   Other responsibilities may include but are not limited to: Filing folders, Managing SAP for material accountability at TBF-100 and at NCTM, ordering materials for sampling, coordinating with Materials Management/Warehouse Department on release of components and chemicals, and acquiring BSE/TSE, OAF, USP Class VI statements and/or applicable documents from vendors.

Summary:  This position is responsible for the design, development, maintenance, and delivery of technical training for the Manufacturing organization.  Prepare training design documents and manage instructional design projects. 

Summary This position requires working 2nd shift. The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations.  This individual will supervise a team of employees directly or indirectly in these production process units.

Summary: This positon requires working 2nd shift.   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 may include any of the following: - Upstream Unit: - Single-Use Cell Culture Vessels/Bioreactors up to 2000L - Bacterial Fermentation Culture Vessels up to 2000L - Alpha Wasserman Continuous Flow Centrifuges - Disposable Magnetic Mixing Bags and Totes - Cell Expansion and Propagation - Banking/Cryopreservation of Cell Lines and Viruses - Hyperstack, Cellstack, and other Adherent Cell Technologies - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Downstream Unit: - Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration - Medium to Large-scale Chromatographic systems (ÄKTA). - Pre-Packed Columns from 1L to 100L - Single use mixing systems (Pall & GE) - Single Use connectivity types such as GE DAC and Colder AseptiQuik - Bulk filling - Aseptic process simulation and drug product filling - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Buffer Preparation Unit: - Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures - Integrity testing of filters

Summary: This position requires working 2nd shift.   The Manufacturing Technician III will work directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following: - Upstream Unit: - Single-Use Cell Culture Vessels/Bioreactors up to 2000L - Bacterial Fermentation Culture Vessels up to 2000L - Alpha Wasserman Continuous Flow Centrifuges - Disposable Magnetic Mixing Bags and Totes - Cell Expansion and Propagation - Banking/Cryopreservation of Cell Lines and Viruses - Hyperstack, Cellstack, and other Adherent Cell Technologies - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Downstream Unit: - Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration - Medium to Large-scale Chromatographic systems (ÄKTA). - Pre-Packed Columns from 1L to 100L - Single use mixing systems (Pall & GE) - Single Use connectivity types such as GE DAC and Colder AseptiQuik - Bulk filling - Aseptic process simulation and drug product filling - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Buffer Preparation Unit: - Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures - Integrity testing of filters

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: This position requires working 2nd shift. The Manufacturing Technician II work directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following:  

Summary:  The Senior Scientist - Downstream Process Development, functions independently and productively in the Downstream Process Development Group actively engaged in process development within a team based PD laboratory.  The individual should display strong technical knowledge and scientific understanding of protein purification as well as having experience in process development at both small and large process scales. The individual will provide significant scientific and technical contributions within the Process Development Group.