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Fujifilm Diosynth Biotechnologies, U.S.A., Inc. is seeking Downstream Production Technicians (all levels) to work in our Downstream Manufacturing group. The successful candidate will execute Development and Production processes as well as the accompanying documentation. This position could either be a day shift position (7:00 am – 7:00 pm) or a night shift position (7:00 pm - 7:00 am). The candidate hired will be working on day shift first for training, and then transition to the night shift if assigned to nights.
Summary: The Sr. Manufacturing Process Engineer is a mid-level position in the Manufacturing Technology Support (MT&S) department in support of the SATURN mAb manufacturing facility located at the Texas BioManufacturing Facility – 100 (TBF – 100) 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. 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: 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 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.
Summary: The Technical Operations – Technical Writer will be responsible for drafting batch summary reports for executed manufacturing campaigns to support client needs. Additionally, will be responsible for the creation and revision of procedures and protocols to support manufacturing activities. This role requires an understanding of GMP monoclonal antibody production, as well as an active approach to learning the latest best practices across the business.
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.
The engineering-automation team at Fujifilm Diosynth Biotechnologies U.S.A., Inc. is offering summer internships for college students majoring Engineering disciplines. The successful candidates will have completed their sophomore or junior 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.
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 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 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 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 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 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 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 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
Summary: The Lean Six Sigma (LSS) Project Lead is responsible for leading, managing, and delivering process improvement projects at Fujifilm Diosynth Biotechnologies, Texas in order to achieve annual goal delivery, revenue plan, and long-term strategic initiatives. With minimal supervision, the incumbent will provide on-going advice, coaching, mentoring and direct support to staff and managers (particularly Green and Yellow Belt candidates) on Continuous Improvement processes and practices across the business as required. Additionally, this individual will be expected to deliver measurable cost reductions as a result of deploying Lean Six Sigma (LSS) tools both directly and indirectly through training delivery and coaching in LSS tools to others in the business.
The Senior Commercial Development Director – Drug Product will work with the VP Commercial to co-develop and execute commercial strategies aligned with FDB budget/growth plans in a specific territory or technology area.
This is a global position that will support all four sites (Raleigh, NC, College Station, Texas , Billingham, United Kindgom, or Hillerod, Denmark ). This position can be based at any of our locations around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site.
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.
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.
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.