The Warehouse Associate is responsible for the physical and administrative tasks of GMP receiving of GMP materials for Manufacturing use and just in time processing of final drug product orders for clinical and commercial distribution.

Summary:   Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking an eQMS Manager to lead the configuration, implementation, analysis, and maintenance of the electronic Quality Management Systems (eQMS). This role ensures compliance with cGMP, and regulatory requirements while optimizing eQMS functionality and efficiency. The ideal candidate will have strong leadership skills, technical expertise in eQMS systems, and experience with...

Summary:   The Quality Assurance Regulatory Affairs Supervisor is responsible for supporting the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Diosynth partner companies. The primary focus of this position is on moderate to complex regulatory submissions in both eCTD and non-eCTD format. Actual work assignments are based on the FUJIFILM Diosynth portfolio of work along with the incumbent's experience, knowledge, demonstrated technical skills, and...

  Summary: The QC Stability Coordinator I, will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data. The Quality Control Coordinator I, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for...

Summary: Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking Quality Assurance (QA) Validation - Associate Director to oversee the review and approval of commissioning, qualification, and validation protocols, reports, and discrepancies. This role will ensure compliance with FUJIFILM Diosynth Biotechnologies’ quality policies, site SOPs, and regulatory requirements while providing strategic leadership to the validation team.  

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.

Summary:  Under supervision of the Supervisor, Logistics Specialist III is responsible for the assurance of accurate receipt, verification, record keeping, distribution, and shipment of materials and goods.

Summary:  Under general direction, the Logistics Specialist II is responsible for the accurate receiving, packing, shipping, and external distribution of cGMP (current Good Manufacturing Practices) and non-GMP materials in support of company operations.

Summary:  Under general supervision, the Logistics Specialist I is responsible for the accurate packing, shipping, and external distribution of cGMP (current Good Manufacturing Practices) and non-GMP materials in support of company operations.

The Principal Quality Officer, (FUJIFILM Life Sciences) FFLS Corporate Quality Office is proactive senior level position designed to provide proactive compliance oversight through advisory audits, data-driven insights, and collaborative support at FUJIFILM Life Sciences platform level.   By fostering transparency, learning, and risk awareness, the FFLS Corporate Quality Office assists FFLS companies turn audits into opportunities for growth while maintaining consistency, accountability, and regulatory excellence across the...

Summary: The Quality Control Project Coordinator III will construct, maintain, and oversee the Quality Control Testing Schedule to include release testing, stability testing, and method qualification activities.  The Quality Control Coordinator III, under general direction, will be responsible for implementing a Quality Control Master Schedule to guide QC activities supporting batch release and stability testing.  The position will also require frequent communication with the...

Fujifilm Diosynth Biotechnologies U.S.A., Inc. is seeking a Production Technician II. The successful candidate will be performing glass wash, cell culture sterilization techniques, support mammalian cell culture manufacturing processes, sustaining purification of bio-pharmaceuticals, operate various process equipment, documenting daily manufacturing operations in a cGMP environment, working with single- use and stainless steel bioreactors, fermentation, and/or filtration.  This will be a first shift role 7am-7pm. 

The Raw Material Sampler 3 position is responsible for sampling of materials and products at the Holly Springs FDBN large scale manufacturing facility, which produces Drug Substance (DS), Drug Product (DP), and Finished Goods (FG) products. This role works with multiple functions to support operations: Warehouse, Supply Chain, Quality Control (QC), and other customers, as needed. The Raw Material Sampler 3 uses Systems and Applications

The Director, Operational Excellence is responsible for driving continuous improvement initiatives and promoting Lean Sigma methodologies across the manufacturing facility. This role leads the implementation and sustainability of process improvement projects, reduce waste, optimize processes, and ensure that the facility meets its operational goals with a focus on efficiency, quality and cost reduction. This role also helps to define, establish and nurture a continuous improvement culture. This role is responsible for defining what good looks like starting with establishing the foundations of a strong program, developing and rolling out the right tools to be used, training to help all levels...

The QA Specialist, Operations (Nights) is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes for 12-hour overnight shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that applicable DSM systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during the shift and resolution or mitigation of issues occurring during operation.

The QA Specialist, QC Compliance is responsible for partnering in the Quality oversight of the Quality Control area. The QA Specialist helps drive Quality oversight for the direction of all QC laboratory processes, from project phase through operational readiness, and provides oversight of validation program execution for these processes. This role collaborates with other project teams and QA departments at other sites to align strategies and procedures. In operations, the role ensures that all QC laboratory systems and processes are operated and maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration, as well as QA...

The job holder will primarily support Project Managers and the Finance team with commercial and contract management, profitability analysis, business partnering to strategic commercial projects, pricing, and sales and operational planning.

The Digital Marketing Operations Senior Specialist is a global role requiring proven experience in developing, managing and optimizing the marketing technology stack and ecosystem. This role within the Global Marketing team is responsible for executing omni-channel demand generation campaigns. The individual will also develop and maintain SEO optimized web-pages, configure lead capture platforms for events, and deliver timely, accurate, and insightful reporting and analytics across the managed platforms enabling the Global Marketing team to achieve optimal results.

Summary:  The Manufacturing Readiness Coordinator II assists the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones.

The Quality Assurance (QA) Analyst I, under direct supervision, will be responsible for assisting with the review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting with product related activities; Assisting with Quality audit functions; Identifying process and Quality System improvements.   Reports to     ...