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At a Glance: Are you keen to start your career in Biotech? Are you interested in learning about complete solutions in pharmaceutical manufacturing and advancing tomorrow’s medicines? Do you enjoy the freedom to act and have passion to learn?
What can you expect?
Fujifilm Diosynth Biotechnologies Texas (FDBT) offers university graduates the opportunity to become part of our Biotech organization and join us on our journey of innovation. The two-year Graduate Program will start in January 2022. The Fujifilm Graduate Program offers the opportunity to work in our College Station, Texas location.
The program provides you with a fast track into FDBT’s organization and aims to equip you with highly innovative knowledge and skills to develop a successful, long-term career at FDBT. As part of multicultural and high-performing teams, you will work on a broad variety of state-of-the-art solutions.
The QC Lead Associate II – Data Reviewer is a senior analyst position able to perform independently in a high throughput, right-first-time, GMP laboratory environment, while meeting production schedules and project milestones.
The primary responsibilities for this role are to ensure that all data generated in the QC Microbiology laboratory is technically sound, meets ALCOA+ requirements, and is available to support business and project timelines. The reviewer will be responsible for identifying errors, ensuring GMP compliant corrections when possible, and escalating to management when appropriate. The reviewer will not be responsible for scheduling or overseeing testing, but may be consulted for project planning or investigation support. The reviewer may be responsible for creating reports and/or CoA’s based on the data generated.
Summary: The Microbiology Analyst III will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
Summary: The Microbiology Analyst II will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
The QC LIMS Technician I is accountable for support of the Laboratory Information Management system (LIMS) in accordance with appropriate regulatory, corporate, and scientific guidelines. The QC technician will work under the guidance of other experienced LIMS team members for guidance. S/he will be responsible to implement approved configuration changes within the LIMS platform as outlined in controlled change management records. The position will also be accountable to support documentation revisions in accordance with governing SOPs to ensure the system and procedures operate in a state of control. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success.
The QC LIMS Technician is responsible for configuration and ongoing maintenance of the Laboratory Information Management System. This positon is responsible for ensuring that the LIMS system meets the requirements of the LIMS procedures. The LIMS Technician works closely with Quality Control, Analytical Development, Manufacturing and Quality Assurance to ensure compliance with GMP requirements.
Summary: As part of the Human Resources team, the Human Resources Recruiting Specialist will be responsible for supporting the staffing efforts of Fujifilm Diosynth Biotechnologies Texas, LLC (FDBT) and building a strong workforce that adds to the company’s bottom line. This highly skilled HR professional should possess knowledge of employment and labor law, have a deep understanding of recruiting and possess strong interpersonal and communication skills. The HR Specialist will be expected to recruit potential candidates, screen them, and recommend them for placement. The process of recruiting may involve both internal and external sourcing methods, thereby requiring the HR Recruiting Specialist to be adept at understanding where and how to locate candidates.
We are looking for a Senior Electrical Engineer for our project who wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. More importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered.
In the project phase, your main responsibility as the Senior Electrical Engineer will be to provide engineering input about design of the electrical systems, equipment specifications, P&ID’s, development of maintenance and operating procedures among other duties.
We are looking for a Senior HVAC Engineer for our project who wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. More importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered.
In the project phase, your main responsibility as the Senior HVAC Engineer will be to provide engineering input about design of the GMP and non-GMP HVAC systems, equipment specifications, P&ID’s, development of maintenance and operating procedures, and other duties deemed appropriate to support the project.
We are growing our locations and are investing more than $40 million for a new facility in Watertown, Massachusetts. We are looking to hire a Site Services Supervisor to support the facility operations, materials management, shipping/receiving, and equiptmant maintiance and calibration functions. This position will work closely with supporting groups at our Texas site and with contractors to perfrom these functions.
The initial Boston facility is an 8000 sq.ft. Process Development & Analytical Development laboratory with a capacity of up to 6 client programs per year. The second phase Boston facility is a 36,000 sq.ft. space that will consist of Process Development, Analytical Development, and clinical GMP manufacturing with a capacity of up to 15 programs per year. The phase 2 facility will be operational in 2023 and is on the same campus as the initial facility.
FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Senior Instrumentation and Controls Technician to perform general to advanced Instrument and Controls repairs/troubleshooting/preventive maintenance (PM) to all plant equipment/systems, process measurement and control, utility, laboratory and bench top instrumentation and to perform routine scheduled calibration.
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 I 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
Summary: Fujifilm Diosynth Biotechnologies, Texas, Inc. is offering temporary work opportunities (40 hours per week) for current or recent Graduates in Life Sciences or related fields. We offer a supportive, collaborative environment that encourages development of necessary skills, identify and attain career goals. This is a great opportunity to gain invaluable experience working for an industry-leading biopharmaceutical contract manufacturing organization. The position offers prospects of working experienced scientific personnel on key projects. The duration of the position can be discussed with the supervisor and Human Resources. The temporary position also offers possibilities of translating into a full time position within Fujifilm Diosynth.
We are looking for a site senior leadership team member who will join as Head of Manufacturing on our journey to establish the largest end-to-end cell culture CDMO facility in North America. As Head of Manufacturing, you will be responsible for Drugs Substance Manufacturing, Drug Product & Finished Goods Manufacturing and Supply Chain within the new production facility.
You will be responsible for heading up and setting the direction for the manufacturing part of the project. As Head of Manufacturing, you will play a major part in setting strategic leadership direction for FDB globally and contribute to new standards within our area by leveraging existing experience within large-scale manufacturing of biologics, medical device assembly, packaging and supply chain management.
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.
FDB is currently seeking a Head of Finance in our Morrisville, NC location. Reporting to the CFO US, the Head of Finance is responsible for directing all operational business and financial reporting, planning, information systems and capital expansion functions.
The Sr. Manager – Drug Product Operations is recognized as subject matter expert with regard to manufacturing processes and system owner. The Manager will:
- Ensure delivery of production execution schedule and adherence to daily and weekly schedule.
- Initiate and oversee implementation of new technology and modifications to existing technology aimed at cost reduction, efficiency improvements, minimization of downtime and quality/safety enhancement.
- Make recommendations regarding departmental profit plan, capital planning, budget, and standards development.
- Recognizes and investigates opportunities for financial savings across a broad spectrum of operational activities.
- Be able to identify and communicate improvement opportunities and results.
- Coordinate and lead production training across shifts.
- Identify operational needs for special projects (new product sub team, capital projects, etc.) ensuring site/divisional linkage is achieved.
- Mentor and train new managers and other new departmental employees.
The Associate Director, as part of the Global Program Design Team, will secure new business in line with the company vision. This team is responsible for delivering bespoke, high quality proposals to potential clients based on extensive understanding of global FDB’s technical and business capabilities, and an ability to match them to client’s actual needs. Proposal building requires in depth understanding of FDB program management systems, technical capabilities of Process Development, manufacturing capabilities, the quality aspects of program delivery, regulatory requirements, and program financials. Program Design directly contributes to new business acquisition and market share growth by projecting to potential clients FDB's technical competence, operational excellence, vast experience, and broad capabilities.
Summary: The Materials Management Specialist is responsible for drafting and implementing supply chain management procedures governing the receiving, warehousing, ordering, shipping and internal distribution of cGMP (current Good Manufacturing Practices) and non-GMP materials.
Summary: The Quality Assurance (QA) Specialist for Training will be responsible for helping to deliver Quality Specific training for the department and the site. They will be responsible for delivery of onboarding training.
We are looking for a Head of Process Equipment, who will join our journey to establish the largest end-to-end cell culture CDMO facility in North America. As Head of Process Equipment, you will be responsible for setting the direction and managing central workstreams in a $2 billion global project.
We offer the possibility of building and leading teams of dedicated specialists within the area of Drug Substance Manufacturing (DSM) and/or Drug Product Manufacturing and Finished Goods Manufacturing (DP&FGM). You will be directing them on the journey by leveraging your existing experience as SME and people manager in Greenfield capital projects and technical projects. You will be responsible for design, optimization and implementation of manufacturing processes, equipment and technology. Additionally, you will take up the responsibility for securing that the equipment is ready for operations.
We are looking for a Head of Procurement, who will join our journey to establish the largest end-to-end cell culture CDMO facility in North America. You will be responsible for setting the direction and managing a central workstream in a $2 billion global project.
As the Head of Procurement, you will have the strategic role of developing world-class procurement processes and frameworks. You will be responsible for managing this function and work closely with Finance, Legal, workstreams and 3rd parties to ensure procurement activities are carried out in accordance with company standards.
We offer the possibility of building and leading a visionary business-driven team while utilizing your previous experience and skills within strategy, processes, and negotiation to ensure functional leaders are equipped with the knowledge to perform their procurement related activities.