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.

Support identification of new business opportunities and acquisition of new business from potential and existing customers through industry research, prospecting, and client interactions. Support overall sales productivity improvement efforts via supporting the implementation of best practices, supporting the improvement of existing processes, ensuring the integrity of various sales databases, and ensuring the accurate analysis and reporting of data to leadership.  

Fujifilm Diosynth Biotechnologies U.S.A., Inc. is offering a summer internship in our Supply Chain Department.  The successful candidates will have completed their collegiate sophomore year or higher.  We offer a supportive, collaborative teaching environment to develop our Interns' skills and identify their career goals.  This is a great opportunity to gain invaluable experience working for an industry-leading biopharmaceutical contract manufacturing organization. 

We are looking for a Lead of Automation to join in on our journey towards establishing the largest End-to-End cell culture CDMO provider in North America.   As Head of Automation, you will be responsible for setting the direction and managing the automation activities in a $2 billion global project. We offer the possibility of building and leading a visionary business-driven digitalization team with the responsibility for implementing state of the art automation and digital technologies at the new factory.   We are looking for a leader with positive energy, entrepreneurship and courage to empower and inspire others. You will join an organization focusing on growth, a steep learning curve and most importantly a focus on people and what you can bring to the table.

We are looking for a dedicated, result-oriented Senior Process Engineer to join our Engineering Sciences team. As a Technology Lead, you will be providing engineering technical leadership, and primarily designs, and specify new equipment for all Drug Substance (DS) processing equipment and utilities on the site. You will be a subject matter expert in technical investigations and in the technology transfer of new products/processes. You will champion transformation of engineering, manufacturing and facility technologies, participate in industry forums and provide technical engineering expertise for new processing equipment installations and modifications to existing equipment.   We are looking for someone with positive energy, entrepreneurship and courage to empower and inspire others. You will join an organization focusing on growth, a steep learning curve and most importantly a focus on people and what you can bring to the table.

We are looking for a Head of Engineering Technology to manage our Engineering Science department in North Carolina. As Head of Engineering Technology, you will be responsible for the Site Master Plan (SMP) and technical leadership in the assessment and process design / fits for new equipment, facility and operational capabilities. In addition, you will drive engineering studies and provide expertise and drive implementation of improvements in DSM, DP & FGM. As the Head of Engineering Technology, you will ensure that assigned deliverables are completed on schedule and within budget. In this role you will be managing the Engineering Science staff by developing department vision and strategy and performs other duties as required in support of department, functional and company goals.

FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Senior Engineering Manager reporting to the Director of Engineering. The successful candidate will lead the Computer Systems Validation (CSV) and Lab Engineering (LE) groups as part of the Engineering Department. The position will ensure deliverables for the respective groups are well established and in line with their stakeholders expectations. The CSV group consists of 2 exempt FDBU employees and 1-2 contractors responsible for validation of computer systems and applications. The LE group consists of 5 exempt FDBU employees responsible for supporting installation of new analytical equipment as well as troubleshooting and preventative maintenance. The Senior Engineering Manager oversees the day-to-day activities as well as implementation of new technology and continuous improvement aimed at cost reduction, efficiency improvements, system sustainability, and quality/safety enhancement. The Senior Engineering Manager will ensure adequate support of capital projects with a CSV and/or analytical equipment   element in accordance with FDBU and GMP standards to include Data Integrity. As such, this position requires solid working knowledge of computer systems validation and analytical equipment networking.

The Bioassay Development group is seeking a Scientist II with experience in cell-based assays, ELISAs and Plate-based testing. The successful candidate will primarily be responsible for the development and qualification of assays for the characterization and identity, purity, and strength assessment of recombinant protein drugs. The position will also support the management/report of deliverables to internal &/or external customers, provide sample testing support to process development, independent generation of analysis reports and other documentation. The successful candidate will also be responsible for the development and qualification of cell-based methods, ELISAs and qPCR assays for the characterization and testing of recombinant protein drugs.

Summary:The Maintenance Planner/Scheduler under the supervision of the Facilities Support Supervisor is responsible for the planning, scheduling and performance of the maintenance program including the oversight of the Computerized Calibration & Maintenance Management System (CCMS/CMMS) in support of multiple manufacturing facilities such as 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).Primary responsibilities include managing the daily maintenance operations such as screening of incoming work orders, identification of job requirements, procurement of equipment and specialized tools, scheduling of maintenance staff, parts inventory control and monitoring of maintenance tasks performance. This position will interact with other maintenance and technical trades, such as manufacturing operators, engineers, calibrations technicians, validation, quality and external suppliers in order to provide a high level of excellence over the maintenance operational activities of FDBT.

Summary:  The Facilities Maintenance Technician, under the supervision of the Site Services Supervisor will be the individual responsible for performing routine building maintenance tasks in multiple fields such as carpentry, masonry, painting, plumbing, electrical, heating, ventilation, and air conditioning (HVAC), and general cleaning among others in support of multiple facilities of Fujifilm Diosynth Biotechnologies. Primary responsibilities include facilities and other structures inspection to detect malfunctions and identify needed repairs, perform minor electrical maintenance such as replacement or repair of fixtures, perform minor plumbing maintenance such as replacement or repair of leaks in drains and faucets, perform minor painting, carpentry and masonry work such as drywall repairs, framing installation, hanging doors, furniture dismantle/installation and fitting locks/handles, and operate and maintain HVAC systems and associated equipment. Maintenance activities would include troubleshooting, preventative and corrective interventions. This position will be required to use technical manuals, on-line resources and OEM representatives to maintain the facility and associated equipment/systems operational with a minimum of downtime. This position will work with other maintenance and technical trades, such as contractors, engineers, metrology, validation and quality to help maintain the facility and associated equipment/systems operational and in GMP condition. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory.   This position will also work in support of the Environment, Health and Safety personnel (EHS) to ensure the systems are operated safely and within limits

We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.   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.     The Financial Analyst will analyze financial status by collecting, monitoring, and studying data; recommending actions. Financial planning and strategy along with Process Improvement and problem solving are key responsibilities.

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 Facilities Maintenance Supervisor, under the supervision of the Facilities Maintenance Manager, will be responsible for day-to-day aspects of operating and maintaining the facilities in support of the operation of the Texas Biological Facility (TBF), the Flexible Biological Facility (FBF), as well as the integration of the National Center for Therapeutic Manufacturing (NCTM) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). The Facilities Maintenance Supervisor in support of the Facilities Maintenance Manager will be the lead maintenance and utility contact for covering the maintenance needs and with assigned personnel or contractors maintain the facility support equipment.  This positon will also provide support for proper installation of new facilities support equipment, working with the corresponding calibration, operations and validation department personnel, and with the various contractors and consultants working on the projects.  This position will work in support of the Facilities Manager and with Employee Health and Safety (EHS) to ensure a safe workplace is developed; and with Procurement for development of repair parts and spare parts strategies; and with Calibration manager as needed. 

Summary: The Manufacturing Associate Process Engineer is an integral part of the Manufacturing Technical Operations department, supporting Gene Therapy manufacturing at the National Center for Therapeutics Manufacturing (NCTM) and the Flexible Bio-Manufacturing Facility (FBF200), located in College Station, Texas.  This position will report directly to the Manager of Technical Operations, Gene Therapy Manufacturing.   Works independently, and with colleagues, to provide expertise and assistance for the design, development, standardization and maintenance of an operational biotechnology utilized in the manufacture of a variety of gene therapy, protein, and other types of drug substances.  This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit.  Operational biotechnologies include:  Isolators and biosafety cabinets and their use in cell propagation, Cell Culture/Single Use Technology for adherent and suspension culture, Dispensing and Mixing and Buffer Preparation, Chromatography, Tangential Flow Filtration, various filtration technologies, cCentrifugation, and Bulk Fill.  This position will also create training programs and perform training for manufacturing technicians in the unit operation categories.

Summary:  The Associate 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 experience with several 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 primarily focus on executing analytical method protocols, summarizing data, coordinating instrumentation needs, finalizing test methods and ensuring a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success. The candidate will be expected to follow cGMP documentation practices.  

Summary:  The Assistant Scientist – Analytical Method Transfer (AMT) will function collaboratively and productively in a team devoted to ensuring the quality of effective analytical methods at FDBT. This is an entry-level position that will require training on laboratory instrumentation and appropriate documentation of results to support customer programs.   The AMT group primarily performs Tech Transfer, Qualification, and Validation of test methods coming out of the FDB analytical groups and transitions them into our Quality Control department. The position will mostly focus on learning a subset of analytical techniques and following the procedures outlined in approved protocols, then analyzing and summarizing data. The individual will also be responsible for supporting the group with tasks such as ordering supplies, equipment maintenance, coordinating sample shipments, and preparing buffers. The candidate will be expected to follow cGMP documentation practices.

Summary:  The Work order coordinator, under the supervision of the Facilities Support Operations Supervisor, or designated supervisor will be responsible for performing various aspects of coordination, Work order 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 to support facilities with planning and scheduling equipment for biotech processing equipment. This position will be required to use technical manuals, on-line resources and OEM representatives to maintain the equipment. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory. This position is for day shift.

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:  The Document Control Scanning Support – Temporary, will be responsible for scanning all GMP Documents, Stamping “True Copy”, and verifying the accuracy of the documents. Exact dates of the temporary assignment will be determined between HR and the Supervisor.

Summary The Temporary Environmental Monitoring Technician, under general direction, will be assisting with routine and non-routine environmental monitoring and other duties within the Quality Control (QC) Laboratory. This position has the primary responsibility of assisting with environmental monitoring. Other responsibilities may include but are not limited to: Daily reporting of instrument calibration, and other general lab and lab related administrative responsibilities, as needed. This position may last up to, but will not exceed 12 months.