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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 currently hiring for a business development specialist (internally known as commercial development specialist). The business development specialist will support identification of new business opportunities and acquisition of new business from potential and existing customers through industry research, prospecting, and client interactions. They will 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.
As a business development specialist, you are a key link between our customers and the FDB team, and will typically be our customer’s first point of contact at FDB. You have the ability to foster collaborative relationships with both customers and key internal stakeholders, are a skilled communicator, and have the ability to quickly get up to speed with our various technologies. As one of FDB’s biggest ambassadors, you are a key frontline representative of our company: embodying our mission of advancing tomorrow’s medicines and our passion for collaborating with our partners for life. If you want a high-visibility, cross-functional, intensely collaborative position with undeniable importance – apply today.
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.
Principal Software Engineer - Bothell, WA
FUJIFILM, Sonosite, Inc . We are an innovative and high performance culture with tremendous opportunities. People who work here are given the unique opportunity to contribute to the advancement of healthcare throughout the world. Headquartered in Bothell, WA USA, Fujifilm Sonosite is represented by a global distribution network in over 100 countries. Since its inception, Fujifilm Sonosite’s lightweight, robust products have created and led the point-of-care ultrasound market. From sophisticated urban hospital emergency rooms to clinics in austere, remote villages, Fujifilm Sonosite systems are used by over 21 medical specialties and provide clinicians around the world with a cost-effective tool for improving patient safety and workflow efficiency. Fujifilm Sonosite holds a number of prestigious design awards and has in excess of 145 patents.
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 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 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.
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 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 Manufacturing Readiness Coordinator I 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 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 Manufacturing Compliance Coordinator II leads the tracking, coordination, and closure of Manufacturing CAPAs, change controls and deviations, and assists in supporting the timely release and disposition of batches and other post-execution activities.
We are hiring for a Director of Internal Audit to be located in Valhalla, NY or remote from the following states: NY, NJ, CT, PA, DE and MA.
As the Director of Internal Audit you will be responsible for leading the performance, process, financial and compliance audits, among others, covering Fujifilm Holdings America Corporation subsidiaries and affiliates, primarily in North America and Latin America. This position will be responsible for reviewing our companies’ business processes and controls, assessing and mitigating risks, providing reports and feedback to management and creating action plans to ensure continuing improvements to our companies’ business processes and internal controls. The Director of Internal Audit will be involved in regional and company-specific risk assessments on a regular basis and work with other functions and subsidiaries to develop countermeasure plans.
Our Internal Audit team serves the crucial role of ensuring that our companies have adequate systems of internal control, confirming that systems are operating satisfactorily, assessing the accuracy and reliability of our companies’ financial reporting, safeguarding company assets and information, monitoring adherence to corporate policies and procedures and providing our companies’ leadership teams with risk mitigation plans and recommendations. The Director of Internal Audit will provide key input into the development of the company’s annual audit plan, lead and manage the Internal Audit team and help develop programs that assist our companies in improving operational efficiencies, improve internal controls and minimize risk across our businesses.
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.
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.
We are hiring two Equipment Maintenance Technicians for our 3rd shift. The Equipment Maintenance Technicians perform general equipment repairs and maintenance on our production, packaging, quality and research and development (R&D) equipment to ensure the site meets cGMP and OSHA compliance. This role also serves as the on-site contact person for contractors. The Equipment Maintenance Technicians are expected to work second shift, third shift, weekdays, weekends, and holidays as necessary and as assigned. The Equipment Maintenance Technicians will also be expected to respond to emergency production and packaging equipment troubleshooting needs.
Summary: The Quality Control Compliance Manager leads the tracking, coordination, and closure of Quality Control’s CAPAs, change controls and deviations. The successful candidate will also assist the QC department in OOS/OOT investigations. The candidate will ensure all PRs and change controls are closed out in a timely manner.
Summary: The Quality Control Stability Coordinator will be responsible for carrying out supporting activities on the stability program according to current regulations. This includes working with Clients to draft stability protocols, physically setting up stability studies according to respective stability protocols (staging), updating and maintaining stability planning/scheduling tools, ensuring timely execution of stability pulls at each time point, ensuring timely execution of in-house or external testing, writing summary reports, and ensuring the timely delivery of customer-oriented data and documentation.