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Summary:
The Scientist I assist in the planning of, conducting, evaluating, and interpreting routine laboratory experiments. The individual monitors ongoing experiments and identifies and resolves or suggests alternates or solutions to complex occurrences. The individual understands and applies use of equipment, technology and materials associated with analytical development and related studies and projects. The individual takes a more active role in non-routine analytical or process development activities.
This role is dedicated to driving operational excellence through the application of Lean methodologies within the Quality Control operations in a GMP environment. The successful candidate will have a passion for reducing waste, improving process efficiency, and enhancing overall quality.
Summary: The Manufacturing Director – Gene Therapy is responsible for the planning, directing, and coordinating activities related to the manufacturing processes for the National Center for Therapudic Manufacturing (NCTM), and Flexible BioManufacturing Facility – 200 (FBF – 200), while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics. The Manufacturing Director/Sr. Director will work as the Value Stream Owner for the VGT Modality and all supporting departments to ensure appropriate Return on Sales. The Manufacturing Director will be responsible for the cGMP production, manufacturing and...
The Sales Specialist, Diagnostic Oncology, in the Invitro Diagnostics Division, is responsible for identifying, prioritizing, and establishing relationships with Key Accounts and Opinion Leaders within the Liver/Hepatology Medical Oncology community. Manage specific assigned geographic areas and successfully drive the FUJIFILM HCC Risk Biomarkers sales through that community. As assigned interface with Senior Management teams from major IVD manufacturers. Maintain a comprehensive understanding of IVD reagent systems, distribution modalities, as well as clinical performance and utility of assays.
The IP Counsel is a member of the FUJIFILM Holdings America Corporation (“HLUS”) Legal Department reporting to the Chief IP Counsel. The IP Counsel will work on intellectual property matters for HLUS and its subsidiary companies, both independently and in collaboration with members of the HLUS Legal Department and outside counsel.
Sr. Specialist 1, QC Lab Support works under moderate supervision, supporting and participating in QC activities related to investigations, deviations, OOS/OOT, CAPAs, and Change Controls. This role assists in creating and maintaining GMP documents and processes, collaborating with stakeholders and QA. This role contributes to customer contact and CLO communication to support QC capabilities in delivering materials and results. This role helps ensure QC compliance with policies and procedures. This role participates in project management and process improvement initiatives, developing skills in risk assessment. The role requires the ability to work effectively both independently and as part...
The Regional AD, Procurement is strategic role of developing world-class procurement processes and frameworks. This role is responsible for managing this function and work closely with Finance, Legal, other functions and 3rd parties to ensure procurement activities are carried out in accordance with company standards. This role will be building and leading a business-driven regional team while utilizing your previous experience and skills within procurement strategy, processes, and negotiation to ensure our procurement-related activities foster success of the organization.
We are hiring a Research Scientist – Formulation and Lyophilization. The Research Scientist – Formulation and Lyophilization will be responsible for leading formulation development studies to improve solubility, stability, and bioactivity of recombinant cytokines and growth factors, design and execute lyophilization cycles with a focus on reducing moisture content, improving cake appearance, and maintaining activity. They will evaluate excipients and delivery system compatibility for liquid and lyophilized formats (vials, bags, etc.), and provide scientific guidance to junior team members and support troubleshooting of formulation-related challenges.
This role will perform manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.
Summary: The Process Engineer II, under the supervision of the Director of Engineering, will be responsible for performing engineering activities, new equipment/systems installation, new products introduction support, infrastructure assessments, troubleshooting support and technical expertise for process equipment and site utilities on behalf of the different facilities at Fujifilm Diosynth Biotechnology Texas (FDBT). Equipment support includes bioreactors, incubators, filtration skids, chromatography skids, centrifuge, autoclaves, freezers, refrigerators, walk-in cold rooms, QC/PD lab equipment, air cooled chillers, air compressors and dryers, air handling units, MCRs, MBUs, steam/water...
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.
The Automation Engineer 3, MES provides support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. Additionally, this role participates in designing and maintaining the Manufacturing Execution System (MES).
The LEAD PROJECT TEAM SUPPORT ENGINEER-MI provides remote technical, applications and system support for HCUS customers and supported business units. This role primarily interacts with FUJI Technical Assistance Center (TAC), FUJI customers and other FUJI business units with the management, execution, and administration of operational, billable, and more in-depth projects and support. Supports complex issues where analysis of situations or data requires an in-depth evaluation of variable factors which may include customer impact, HCUS business priorities and regulatory requirements. Provides to assistance to all connected teams on technical and product knowledge and department...
The QA Engineer, DSM is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during project phase through to operational readiness. The QA Engineer, DSM is responsible for quality assurance oversight of day‐to‐day activities and resolution or mitigation of issues.
The QA Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Drug Substance Manufacturing (DSM) ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.
The Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability.
The Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability.
The Process Engineer 1 will provide engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability.
The Process Engineer 1 will provide engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability.
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