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Summary: The Technical Writer for Manufacturing Support will be primarily responsible for drafting formulation records and supporting documents for execution of manufacturing campaigns to support client needs. Additionally, this role will be responsible for the creation and revision of Standard Operating Procedures, Work Instructions/training material and any relevant technical documentation to support manufacturing activities. This role requires an understanding of cGMP production, a strong proficiency in Microsoft Office functions, as well as an active approach to learning the latest best practices across the business.
Summary: The Microbiology IV will demonstrate a strong technical background and be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
Summary: Our engineering team in College Station, Texas is expanding, and we are looking for a Laboratory Engineering Technician I. Under minimal supervision the Laboratory Engineering Technician I is responsible for the day to day operational, maintenance, calibration, and troubleshooting support for analytical equipment in manufacturing, QC, and process development. Additional responsibilities include installation and start-up of new analytical equipment in accordance with FDBT standards and cGMP/cGLP regulatory requirements. This position may require support outside of normal business hours.
This position requires a sound working knowledge of pharmaceutical analytical/processing equipment and will provide support and ownership of the analytical equipment and systems including but not limited to Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), Liquid Chromatography, Mass Spectrometry, Ultraviolet-Visible Spectroscopy Plate Reader, Densitometry, Cell Counting, and various analytical data collection systems, i.e., Empower, SoftmaxPRO, and Unicorn. The Laboratory Engineer Technician I will maintain working knowledge for all such systems allowing for effective technical support.
Summary: Senior Laboratory Engineer is a mid-level position in the Laboratory Engineering department of FDBT. The primary purpose of this position is to provide day-to-day technical support for the analytical equipment within Manufacturing, Quality Control, Analytical and Process Development organizations. In addition, this position is a major contributor to implementation of new technology and equipment life cycle monitoring.
Under minimal supervision, the Senior Laboratory Engineer is responsible for the day to day operational, maintenance, calibration, and troubleshooting support for analytical equipment in manufacturing, QC, analytical and process development. Additional responsibilities include supporting the design, procurement, installation and start-up of new analytical equipment in accordance with FDBT standards and cGMP regulatory requirements. This position may require support outside of normal business hours.
This position requires a sound working knowledge of pharmaceutical analytical/processing equipment and will provide support and ownership of the analytical equipment and systems including but not limited to Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), Liquid Chromatography, Mass Spectrometry, Ultraviolet-Visible Spectroscopy Plate Reader, Densitometry, Cell Counting, and various analytical data collection systems, i.e., Empower, SoftmaxPRO, and Unicorn. The Senior Laboratory Engineer will maintain working knowledge for all such systems allowing for effective technical support.
Summary: The primary job responsibilities of this position are to ensure clean room facilities, classified common areas and manufacturing suites (clean rooms) are cleaned, decontaminated, and disinfected according to established cGMP requirements. Responsible for administrative duties, reports, record keeping, material and supplies management, coordination of personnel work activities, troubleshooting, scheduling, and employee performance. Must be flexible to respond to changing priorities and handle changing workflow, including working on multiple projects at multiple sites and/or a flexible schedule as directed by the Shift Operations Manager.
Must be able to work effectively and efficiently in a team-oriented environment and be able to interact with internal departments to improve safety, maintenance, efficiency, and productivity. Adhere to and develop/improve department SOPs, quality compliance GMPs, and other established procedures.
The Manufacturing Trainer is recognized as key support with regard to training of Manufacturing Technicians in operations execution for cell culture and/or microbial upstream and/or recovery and/or downstream manufacturing processing. Delivers training to support Technicians being prepared to meet production execution schedule. Supports implementation of training for operational processes, new technology and modifications to existing technology or operational processes for the purposes of new Technician on-boarding, Technician cross-training or continuous Technician development and Production Schedule Readiness. Recognises and Addresses where Training opportunities exist in order to achieve cost reductions, efficiency improvements, minimization of downtime and quality/safety enhancement. Collaborates inter- and intra-departmentally e.g. with MT&S, ComOps, QA, Site Training to design and deliver fit-for-purpose Training. Receives and provides feedback regarding operational and manufacturing process performance.
The Automation IT Engineer,OpIT (Operations Information Technology) is an entry level up to 6 years’ experience position in the OpIT Engineering group of FDBU.
The Sr. Director, Manufacturing Operations or Director, Manufacturing Operations will be the business unit manager for overseeing all Manufacturing Operations for the organization. This person will oversee the cell culture, fermentation and microbial processing. This role is accountable for achieving the process outcomes for the material conversion processes from program management, process development, and then ensuring readiness and disposition for the client.
The Manufacturing Specialist is recognized as subject matter expert with regard to cell culture and/or microbial upstream and/or recovery and/or downstream manufacturing operations. Ensures delivery of production execution schedule and adherence to daily and weekly schedule. Represents Manufacturing at meetings and tours of manufacturing facility. Initiates and oversees implementation of operational processes, new technology and modifications to existing technology or operational processes aimed at cost reduction, efficiency improvements, minimization of downtime and quality/safety enhancement. Must be able to identify and communicate improvement opportunities and results. Provides feedback regarding operational and manufacturing process performance.
Reporting to the CFO, US, with a dotted line report into the Head of Site, this role is responsible for directing all strategic business and financial reporting, planning, information systems and capital expansion functions. This position will sit in Thousand Oaks, California.
We are looking for a Senior IT System Manager 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 will be to liaise with Global IT teams to stand up the IT systems needed to operate the facility. The IT systems will be needed at different phases during the project you will be working with different functional groups to ensure that the systems are ready in due time for their purposes. We are looking for passionate person within the Quality area who could advice and coach on the best industry practices and help us to implement document management system.
You will function as a local extension of the Global IT team reporting into the Head of IT.
Summary: The Quality Assurance (QA) Risk Management position will be responsible for providing leadership to the Texas site in ICH Q9 principles of Risk Management. Ability to facilitate risk assessments, train future facilitators, provide oversight and tracking of remediation actions, and communicate to leadership on the status.
Summary: FUJIFILM Diosynth Biotechnologies Texas is seeking a dynamic and dedicated Principal Scientist to fulfill the leadership role of the Process Characterization (PC) Unit as part of the Process Development team at the College Station, Texas site. This person will lead a growing team of talented scientists and work directly with counterparts within the FDB global organization to deliver on an expanding globally harmonized PC business model. The PC laboratories will include state of the art instrumentation to support late-stage process characterization activities for biopharmaceutical programs for external sponsors. It is preferred to find a candidate with exposure to upstream, downstream, and analytical biopharmaceutical development and process characterization.
(Relocation assistance provided)
Summary: The Quality Assurance – Sr. Compliance Specialist, will be responsible for supporting performance of the Quality Systems group. The Specialist will assist with the tracking and coordination and closure Change Control records, investigations, and all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.
Summary: The Senior Quality Assurance (QA) Analyst, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally. They will also provide daily guidance, work prioritization and support to other departments, such as manufacturing or QC, in absence of or in conjunction with their manager.
Our work with a myriad of biopharma companies means each project we work on brings a unique set of challenges. As Program Manager, you are the key link between our customers and our FDB team. You have the uncanny ability to work and build relationships with clients and internal cross-functional teams alike, are an effortless communicator, and can quickly get up to speed on our technology, bringing deep knowledge that will serve as the backbone for the project. You have great EQ, are the most organized person on the team, and are skilled at navigating ambiguity.
As the critical point of contact for our partners, our Program Managers are FDB’s biggest ambassadors. You represent our company: our mission of advancing tomorrow’s medicine, our passion for collaborating with our partners for life, and our dedication to seeing every project through with the highest amount of integrity and impact. If you want a high-visibility, cross-discipline, intensely collaborative position with undeniable importance, apply today.
Summary: The Program Director will be responsible for the planning and delivery of programs from the point of contract signature (Scope of Work/Letter of Intent/Contract) to project delivery including technology transfer, and taking a product/process from execution of a client commercial agreement or memorandum of understanding through process development and early stage clinical supply through program closure. The Program Director ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission (strategy and compliance).
The Head of Global Single Use (SU) Validation is responsible for designing, maintaining, and continually improving the validation systems in line with current standards. This Head will oversee all Validation aspects of the Single Use Standard across FDB. They will provide leadership, personnel development and oversite of the Company's validation teams and systems for the standard single use facilities.
Summary: The Manufacturing Readiness Coordinator I assist 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 Technical Operations – Technical Writer will be responsible for drafting batch records for execution of manufacturing campaigns to support client needs. Additionally, this role will be responsible for the creation and revision of PCL’s, procedures and protocols to support manufacturing activities. This role requires an understanding of GMP production, a strong proficiency in Microsoft Office functions, as well as an active approach to learning the latest best practices across the business.