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Search Results Page 13 of 14

Job Locations US-TX-College Station
Posted Date 2 months ago(5/12/2022 2:12 PM)
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
Requisition ID
2021-14933
Job Locations US-TX-College Station
Posted Date 11 months ago(7/28/2021 6:03 PM)
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.
Requisition ID
2021-14932
Job Locations US-TX-College Station
Posted Date 1 month ago(5/24/2022 10:29 AM)
Summary: The Program Coordinator II, with minimal supervision, will support site business planning and customer projects by maintaining relevant databases and liaising with Program Directors.
Requisition ID
2021-14919
Job Locations US-TX-College Station
Posted Date 2 weeks ago(6/17/2022 10:11 AM)
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.
Requisition ID
2021-14917
Job Locations US-TX-College Station
Posted Date 7 months ago(12/10/2021 6:25 PM)
  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. 
Requisition ID
2021-14897
Job Locations US-TX-College Station
Posted Date 9 months ago(9/23/2021 3:42 PM)
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. 
Requisition ID
2021-14871
Job Locations US-TX-College Station
Posted Date 1 month ago(5/18/2022 9:50 AM)
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.
Requisition ID
2021-14776
Job Locations US-TX-College Station
Posted Date 1 month ago(5/18/2022 9:49 AM)
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
Requisition ID
2021-14767
Job Locations US-TX-College Station
Posted Date 1 month ago(5/18/2022 9:50 AM)
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
Requisition ID
2021-14766
Job Locations US-TX-College Station
Posted Date 1 year ago(4/3/2021 12:13 PM)
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: - 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
Requisition ID
2021-14765
Job Locations US-TX-College Station
Posted Date 1 year ago(4/20/2021 2:09 PM)
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.
Requisition ID
2021-14521
Job Locations US-TX-College Station
Posted Date 1 year ago(2/8/2021 2:59 PM)
Summary:  The Downstream Process Development Associate Principal Scientist functions in a supervisory role in the Downstream Process Development Group, actively engaged and engaging others in process development within a team based PD laboratory. The individual will independently lead customer projects and is expected to complete technical assignments through the self-sufficient design, execution and interpretation of complex experiments. The individual will be expected to significantly contribute to the technical growth and mentorship of the Downstream Process Development group, suggest new areas for development, present his or her own original ideas and research findings, and demonstrate a solid theoretical understanding within their own scientific discipline. 
Requisition ID
2020-14095
Job Locations US-TX-College Station
Posted Date 5 months ago(1/14/2022 10:14 AM)
Summary: Senior Laboratory Engineer is a mid-level position in the Laboratory Engineering department of FDBT.  The primary purpose of this position is to provide day-to-day technical support for the analytical equipment within Manufacturing, Quality Control, Analytical and Process Development organizations.  In addition, this position is a major contributor to implementation of new technology and equipment life cycle monitoring.  Under minimal supervision, the Senior Laboratory Engineer is responsible for the day to day operational, maintenance, calibration, and troubleshooting support for analytical equipment in manufacturing, QC, analytical and process development. Additional responsibilities include supporting the design, procurement, installation and start-up of new analytical equipment in accordance with FDBT standards and cGMP regulatory requirements. This position may require support outside of normal business hours. This position requires a sound working knowledge of pharmaceutical analytical/processing equipment and will provide support and ownership of the analytical equipment and systems including but not limited to Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), Liquid Chromatography, Mass Spectrometry, Ultraviolet-Visible Spectroscopy Plate Reader, Densitometry, Cell Counting, and various analytical data collection systems, i.e., Empower, SoftmaxPRO, and Unicorn.  The Senior Laboratory Engineer will maintain working knowledge for all such systems allowing for effective technical support.
Requisition ID
2020-13754
Job Locations US-TX-College Station
Posted Date 2 months ago(5/2/2022 8:37 PM)
For over 25 years, FUJIFILM Diosynth Biotechnology’s mission has been advancing tomorrow’s medicine. In our rapidly growing Texas location, we work in partnership with the most innovative biopharma and biotech companies across the world. We help accelerate their progress, expand their capabilities, streamline their processes, and strengthen their innovation. So, when our customers’ potential cures, vaccines, biologics, and accomplishments make strides – or even become new realities for patients – we know we helped make it happen. FDB has been successfully attracting biopharma professionals to their College Station location from national and international pharma hubs. Employees have relocated from Boston, North Carolina, San Francisco, and Puerto Rico for the more affordable quality of life that College Station offers.   Are you ready to take your life science career to the next level?    Summary 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.
Requisition ID
2020-13592
Job Locations US-TX-College Station
Posted Date 1 year ago(2/8/2021 3:00 PM)
Summary: The Associate Scientist - Upstream Process Development will assist in the development and execution of experiments for the development, optimization, and characterization of  cell-based and viral vaccine processes and will be involved in experimental design, data analysis, and interpretation.  This individual will assist the Process and Analytical Development  Teams to drive processes  towards manufacturing processes for multiple viral projects and provide technical support for associated regulatory filings.  The individual should have familiarity with a range of cell-based and viral vaccine production technologies, including cell and virus expansion, infection, scale-up, harvest and filtration technologies.The successful candidate will also be experienced in basic laboratory techniques.  
Requisition ID
2020-13528
Job Locations US-TX-College Station
Posted Date 4 months ago(2/17/2022 2:50 PM)
Summary: The Quality Control Analyst position, under general direction, will be responsible for performing review of routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory.  The data reviewer is responsible to ensure activities are reviewed in an efficient and cGMP compliant manner.
Requisition ID
2020-13433
Job Locations US-TX-College Station
Posted Date 3 weeks ago(6/10/2022 1:17 PM)
Summary:  The Manufacturing Supervisor – Drug Product Operations will work directly with the processes associated with the Vanrx SA25 Automated Filling machine.  This includes but is not limited to formulation, aseptic filling, vial inspection and vial labeling following cGMP procedures.  This individual will also supervise a team of employees directly or indirectly in the production of Drug Product at FUJIFILM Diosynth.  
Requisition ID
2020-13339
Job Locations US-TX-College Station
Posted Date 4 weeks ago(6/3/2022 3:14 PM)
Summary: The QC Coordinator will construct, maintain, and oversee the Quality Control Testing Schedule to include release testing, stability testing, and method qualification activities.  The Quality Control Coordinator, under general direction, will be responsible for implementing a Quality Control Master Schedule to guide QC activities supporting batch release and stability testing.  The position will also require frequent communication with the Analytical Development and Assay Method Transfer groups to coordinate and schedule method qualification activities.  The Coordinator will assist the QC Analyst’s and QC Management to navigate GMP documents through the EDMS system.  Close attention to detail is required to update the Master Schedule on a daily basis to ensure QC deadlines and milestones are met.  Other responsibilities may include but are not limited to: Compiling data for Batch Disposition.  Attending planning meetings as needed.  Communicating gaps and schedule changes to QC Area Managers.  
Requisition ID
2020-12965
Job Locations US-TX-College Station
Posted Date 10 months ago(8/17/2021 4:03 PM)
State of the art technology at FDB College Station includes Viral Gene Therapies unique in the CDMO space, along with an intense program of preclinical trials underway on a treatment for muscular dystrophy within children.  We’re growing our College Station location, 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.Our employees choose to come to FDB College Station from big pharma companies in order to expand the range of medicines they can work on. We currently have 80 client projects running and offer a broad range of drugs and different types of therapies that constantly expand our employee's professional experience.  What's stopping you advancing your career in life science?      Summary:  The Senior Scientist Upstream will provide technology leadership for the Upstream Process Development for a variety of technical platforms, provide technical support for associated regulatory filings, and improve processes or propose modifications to equipment to deliver improvements.  The Senior Scientist will act as technical lead for the development and optimization of novel cell culture and bioreactor processes for multiple viral projects.  Responsibilities include cell line selection, process development, process scale-up, and tech transfer.  Requires hands-on execution of process optimization, cell culture media, along with process characterization of cell culture production processes that can be transferred to the Manufacturing group as well as external collaborators. 
Requisition ID
2020-12769
Job Locations US-TX-College Station
Posted Date 1 year ago(2/8/2021 2:45 PM)
Summary:  The Process Sciences - Associate Scientist/Engineer, under general direction, functions within a team based organization to actively address cGMP manufacturing issues. The individual is responsible for analyzing process technologies to assist in the technical transfer of new processes into the manufacturing group. This individual must work in a collaborative manner to assist the transfer of biological drug processes from process development (internal or client) groups in a CDMO environment.
Requisition ID
2020-12653