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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.
Summary: The Administrative Assistant/Receptionist (Temporary) provides overall administrative support to the Human Resources Department as well as supporting other departments requiring general administrative assistance. This position will be responsible for providing a professional point of contact for all guests entering and leaving the business office, answering and directing incoming calls, ordering and maintaining office supplies, and assisting with special projects as needed.
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.
The Occupational Toxicologist provides expertise in health hazard identification and risk assessment (primarily occupational and product related toxicology) across Fujifilm Diosynth Biotechnologies’ global sites, ensuring safe laboratory and manufacturing work practices as well as product quality and safety.
We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
The Sr. Quality Assurance Technical Specialist (Supplier and Materials Management) position is a senior technical professional that is a recognized authority within their specialized field. It provides expert leadership for Quality System programs related to supplier and materials management that have significant scope within the organization. The incumbent provides GMP and compliance oversight of supplier management and materials management and other assigned systems, as well as ensuring appropriate and timely technical review/approvals as required by the system. As a Senior Technical Specialist, this role coordinates the execution creation, revision and creation of new materials as well as quality management of existing and newly proposed suppliers. Cross functional interactions are a significant component of this job.
FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Instrumentation and Controls Technician (Internally known as Senior Instrumentation 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.
Summary The Cell Biology Analyst II will be responsible for participating in the Technology Transfer of established methods into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
Summary The Cell Biology Analyst I, under general direction, will be responsible for performing routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory.
Summary: The Senior Automation Engineer provides technical support and accountability for the execution of capital projects that are critical to the success of our business. The Senior Automation Engineer will participate in the development, installation, operation, maintenance, and repair of all FUJIFILM Diosynth Biotechnologies Texas automation systems to meet organizational goals and objectives.This position will also work closely with other operators, calibration technicians and engineers to maintain complex systems.
The Corporate Finance Business Partner M&A will be a business partner to the Strategic Business Development Group (SBD) as well as work alongside the CFO and the VP Commercial Finance, taking the lead on Finance due diligence and integration activities for global M&A.
This role requires an experienced, commercially minded individual who is a quick learner and enjoys working in a fast-paced environment. It will require a good understanding of our competitors and the market in which we operate as well as our internal growth strategy.
Summary: The Quality Assurance (QA) Compliance Specialist II for Audit & Inspection will be responsible for supporting and client audits, regulatory inspections, conducting internal and supplier assurance audits.
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 site senior leadership team member who will join as Head of Product Supply on our journey to establish the largest end-to-end cell culture CDMO facility in North America. As Head of Product Supply, 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 Product Supply, 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.
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.
As a member of the Supply Chain organization, the Contract Master Data Coordinator 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 Contract Master Data Coordinator 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 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 (QA) Specialist III for Audit & Inspection will be responsible for supporting and client audits, regulatory inspections, conducting internal and supplier assurance audits.
The Lead QC Associate I level analyst performs high throughput, right-first-time laboratory work to meet
production schedules and project milestones.
This is a first shift (0700-1700), Wednesday - Saturday position
This testing could include, but is not limited to: aseptic technique, bioburden testing (membrane filtration),
endotoxin determination (kinetic chromogenic, gel clot), environmental and clean utility monitoring, Gram
staining, and culture purity testing.