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Summary: This is an experienced person with in depth and specialized knowledge of cGMP documentation. This position can largely function with minimal or no supervisory oversight for routine duties such as document routing, tracking document review and approval process, assessing document related training requirements and tracking training. Additionally, they have sufficient knowledge and experience to establish and modify comprehensive document control systems which are compliant with cGMP requirements. They may be assigned duties representing Quality in appropriate situations as defined by their management.
Fujifilm Diosynth Biotechnologies U.S.A., Inc. is seeking a Material Control Coordinator to work in our Biotechnology Manufacturing Plant in RTP, NC. The successful candidate will be responsible for performing tasks at pre-defined levels within projects or operations.
The candidate is a competent operation professional responsible for performing tasks at predefined levels within projects or operations. Tasks may be routine in nature, expertise is generally limited to areas of responsibility. The candidate understands the “why” part of the job and demonstrates knowledge of internal customers and support area requirements.
Summary: The Quality Assurance - Compliance Specialist II - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.
The General Accountant Supervisor performs one or more of the following accounting and/or payroll activities: checks and verifies records, prepares invoices and vouchers; posts ledger and general journal entries and/or balances accounts payable and accounts receivable records. Generates reports, conducts specialized research projects and responds to inquiries as required. May reconcile difficult accounts and is responsible for a complete and systematic set of transactions in a specific phase of accounting.
Summary: Our Capital Project team in College Station, Texas is expanding and we are looking for a Senior Project Engineer to ensure deliverables for his/her respective projects are well managed and in line with their stakeholders and company expectations. We are looking for a Senior Project Engineer who can help to plan projects and establish the criteria by which project success will be measured. The successful candidate will be responsible for establishing project inspection criteria, coordinating the review of project designs and ensuring the proper implementation of project elements. If you are a detail-oriented professional with over 10 years’ experience in project management and engineering, we encourage you to apply for this position.
We are looking for a Head of Product Supply to join our senior leadership team and help guide our journey to establishing the largest end-to-end cell culture CDMO facility in North America. As Head of Product Supply, you will lead the Drugs Substance Manufacturing, Drug Product & Finished Goods Manufacturing and Supply Chain groups within the new production facility. This is a unique opportunity to build something that has never been built before. You will set the direction for the manufacturing part of a $2B project and play a major role in setting the strategic leadership direction for Fujifilm Diosynth Biotechnologies globally. You will leverage your experience and knowledge within large-scale manufacturing of biologics, packaging, and supply chain management to create new standards in our organization.
Summary: Manager, Technical Operations – Gene Therapy and Vaccine Manufacturing is an integral management position overseeing the Technical Operations team.
The Technical Operation team will provide Process/Manufacturing Technology expertise to the manufacturing organization to support:
- Customer Program Fit Assessments
- Technical Transfer from PD to Manufacturing
- Equipment SME support
- Manufacturing excellence
- Technical support for trouble shooting
- Technical training
It is expected that members of the Technical Operations team will have a strong background in Process/Equipment Engineering or GMP Bio Pharmaceutical Manufacturing experience.
FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a dynamic individual to fulfill the role of Senior Commercial Process Engineer (CPE) Position, within the Commercial Operations organization. The focus of the Commercial Operations team is to provide technical support to Commercial programs manufactured at FDBU, as well as be the point of contact with the client for the manufacturing department.
The successful candidate must have a background in Biotherapeutic Manufacturing, with a proven ability to work independently and collaboratively to achieve optimized strategies, and execute programs with the ultimate goal of delivering products that transform the lives of patients. The CPE will provide oversight for the technical execution, standardization and monitoring of commercial product(s), as well as drive continuous improvement around production, compliance and safety. The CPE will be the technical subject matter expert for core manufacturing and operational technologies, such as Fermentation, Cell Culture, Filtration, Centrifugation, Chromatography and Single Use Technologies.
The Quality Assurance (QA) Analyst II, under general direction, will be responsible for review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting in and performing product related activities; Assisting in and performing Quality audit functions; Identifying process and Quality System improvements; Acting as a QA liaison internally.
Summary: The Quality Assurance (QA) Analyst III, 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.
Summary: The Quality Assurance - Compliance Specialist III - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.
Summary: The Program Manager, with mentoring and support from the Head of Program Management and/or Associate Program Director or 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 program 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 Manager ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission (strategy and compliance). The Program manager typically manages programs of shorter duration and/or fewer concurrent programs relative to a Associate Program Director.
Summary: The Sr. eQMS Analyst will be the Quality organization's Subject Matter Expert (SME) as it relates to the configuration, implementation, analysis as well as the maintenance of the (eQMS) across multiple FDB facilities.
Summary: The Calibration Technician II is responsible for maintaining and improving the cGMP Calibration Programs at the Fujifilm Diosynth Biotechnology Texas (FDBT) facilities in College Station Texas. This includes complex bio-pharma processing equipment such as Mobile Bio Processing Rooms, Mobile Clean Rooms, Bioreactors, Fermenters, centrifuges of various sizes and process, filtration skids, columns, critical water systems and a variety of analytical and test equipment.
We are searching for a Process Support equipment engineer that will ensure that the cleaning, steaming, and ancillary process equipment deliverables from Fujifilm and from EPCM provider are timely and in the required quality. You will act as driver of the process equipment activities and must be able to, proactively, facilitate cross organizational interaction with external EPCM providers and use your extensive experience from a similar role in large pharma/biotech projects.
We are looking for someone with positive energy, entrepreneurship, and courage to empower and inspire others. You will join an organization with focus on growth, you will have a steep learning curve but most essential there is a focus on people first and what you can bring to the table. We have a diverse workplace for people driven to make a difference.
Summary: The Calibration Supervisor oversees the cGMP Calibration Program at the Fujifilm Diosynth Biotechnology facilities in College Station Texas, including both research and production facilities. The Supervisor initiates, implements, and schedules the calibration of instruments and devices in the facility with an emphasis on planning and scheduling calibration through the use of technicians, and outside resources and vendors. The Supervisor prepares SOPs and calibration instructions for the new instruments entering the system, the periodic calibration of those instruments during their life cycle, and the proper documentation when those instruments and devices may either fail calibration, or be retired from the system. This includes complex bio-pharma processing equipment such as Mobile Bio Processing Rooms, Mobile Clean Rooms, Bioreactors, Fermenters, centrifuges of various sizes and process, filtration skids, columns, critical water systems and a variety of analytical and test equipment. This is a key position in the readiness of the instrumentation and equipment to enable the company to meet the expectations of our clients.
Summary: The Supply Chain Planner is responsible for the planning and execution of materials in support of FDBT GMP projects as per the S&OP asset plan via the site ERP/ SAP system. The Supply Chain Planner will convert the requirements ofthe Process Consumable List after handoff of the required materials and catalog numbers from Process Science. The Supply Chain Planner will create the Bill of Materials, Material Masters and Project Recipes in SAP. In order to create Work in Progress (WIP), The Supply Chain Planner will via SAP, convert planned orders into process orders for material picking in the GMP warehouses. The Planner is required to have the right materials, released and available at the correct time to the correct specification to support the Master Schedule. Materials planning will be conducted via SAP following MRP planning principles. The Supply Chain Planner will work with the Process Development, Process Science, Manufacturing,Quality groups and other areas of Supply Chain to ensure the identification of materials meets the Compliance and Quality requirements for the facilities.
SUMMARY The Senior Validation Engineer, under minimal supervision, will be responsible for drafting and executing utility, process systems and process support systems qualification test work across multiple GMP facilities as well as support cleaning and process validation when necessary. Preparing validation summary reports for the qualification and validation of systems used to manufacture drug or biologics products.
Summary: The Validation Engineer III, under general direction, will be responsible for drafting and executing validation protocols for facilities, utilities, manufacturing equipment and quality control equipment, as well as preparing validation final reports for the same.
Our Capital Project team in College Station, Texas is expanding and we are looking for a Project Engineer to ensure deliverables for his/her respective projects are well managed and in line with their stakeholders and company expectations. We are looking for a Project Engineer who can help to plan projects and establish the criteria by which project success will be measured. The successful candidate will be responsible for establishing project inspection criteria, coordinating the review of project designs and ensuring the proper implantation of project elements.