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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.
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 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.
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.
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 QC Manager will be responsible for managing Analytical and Biochemistry testing within the cGMP Quality Control labs. The manager will be responsible to manage a team of analysts and scientists focused on the analysis of stat, release and stability testing of biotechnology products. The manager will have accountability for exceptions associated with test execution (deviations, CAPAs, OOS, OOT) and be expected to manage each to their timely closure in partnership with technical product leads, the clients and Quality Assurance.
The performance of the team is measured against milestones established on a monthly basis, ownership of the testing milestones resides with the QC management team. The position will be expected to work with peers in Quality Assurance, Analytical Method Technology and Analytical Development to ensure testing turnaround times are met and in accordance with cGMP expectations. The department’s core responsibilities are centered on providing manufacturing support for STAT in-process assays, stability testing of drug substance and client drug product samples, release testing and supplement (protocol based) testing.
A core responsibility of the QC manager will be ensuring the development of the staff. It is the expectation that a culture of ownership and accountability is fostered at all levels within the laboratory setting.
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.
FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a IT Engineering Manager (Internally known as 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.
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.
Summary: 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.
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 Associate Director of Program Design will partner with the Sales and site technical/operations teams in acquiring new business for Fujifilm Diosynth. They will lead technical discussions with potential clients projecting Fujifilm experience and expertise in microbial, mammalian, and advanced therapies. They will develop and author customer-tailored proposals and assist throughout the sales process.
For U.S.-based positions, it is preferred, but not required, that the job holder be based in close proximity to a FDB site (RTP, NC, Boston, MA, or College Station, TX) or in the Western U.S
Regular out of hours calls may be required and travel to other FDB sites 3-4x a year is necessary.
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.
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.
The Materials Planning Manager position is responsible for delivering contracted product per the revenue forecast and establishing a central production plan. This position is also responsible for inventory levels, material readiness and various monthly reports.
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.
The QA Manager (Product Leader) is responsible for specific quality and compliance areas within Quality Assurance for a site. They will manage Quality Assurance systems and staff to meet site quality and compliance expectations. Other responsibilities include being a customer liaison, acting as the project compliance lead for manufacturing readiness (including process validation programs), being the Quality SME during customer audits and health authority inspections, and quality oversight for batch record review, deviation review and closure, managing customer requirements, and final product quality decisions.
As a member of the Supply Chain organization, the Data Analyst/Steward – MDM is responsible for the creation and maintenance of item master material to support Fujifilm Diosynth Biotechnologies supply chain operations, ensuring business continuity, and accurate data quality. They will collaborate with business, operations, and technology stakeholders to utilize processes and workflows to build a strong data foundation for supply chain. Pioneer master data governance best practices with a focus in continuous improvement to promote growth and structure for daily supply chain operations. The Data Analyst/Steward – MDM will also be adaptable to assisting with business or IT projects to advise on master data topics and execute necessary activities.
This is a contract position scheduled to last at least 12 months offering benefits.
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.
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.