Director, QA Drug Substance Operations    Are you a strategic leader with expertise in managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you are motivated and possess strong operational excellence skills, we have an exceptional opportunity for you to lead and grow in a world-class Quality organization as the Director, QA Drug Substance...

The Supervisor, Quality Assurance Operations is responsible for providing supervision and risk-based QA support for the Drug Substance Manufacturing areas and processes.  

The QA Engineer, DSM Operations (Night) is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during the night shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that all DSM systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during your shift and resolution or mitigation of issues occurring during operation. 

The Associate Director, QA for Materials, Supply Chain and QC will be responsible for the supervision of the Quality teams supporting release of materials, Supply Chain functions including warehouse as well as providing Quality oversight for the QC function via supervision ensure that materials released are tested in accordance with GMP regulations. Provides QA support for approval of specifications, documentation, reports, deviations, and changes coming from the QC function. Assures product compliance through Quality systems and effectively ensure initiatives that promote a robust Quality Culture within Quality function and for supporting functions. Proactively engage with the organization...

Senior Associate Scientist role supports Analytical Development operations by executing analytical method development, characterization testing, and data analysis in support of cell therapy processes.  The candidate must be able to quickly adapt and learn new techniques and methodologies.  The role requires strong technical expertise, communication, problem solving and time management skills.  The candidate must have strong laboratory skills in bioassay, cell biology and immunology.  The role requires a self-motivated, detailed oriented individual, able to prioritize, multi-task, and work in a fast-paced & demanding environment.

The HR Intern supports the HR department by assisting in various tasks such as maintaining employee records, conducting recruitment activities, and facilitating onboarding processes. The role exists to provide hands-on experience through exposure to HR operational activities while supporting the efficient execution of HR functions. This position aids in ensuring smooth HR processes and enhancing employee experience through effective administrative support.

The Sr. Analyst 1, QC Raw Materials is accountable for GMP compliant laboratory operations according to USP/EP/JP regulations. The role will be responsible for participating in the Technology Transfer of established methods into the FDBN Quality Control Laboratory. Following Tech‐Transfer Activities, the position will be responsible for performing raw material testing and disposition using the established analytical methods

The Vice President (VP) of Quality Assurance (QA) is a senior leader overseeing QA functions at our Holly Springs site. This pivotal role ensures compliance with regulatory standards, drives quality initiatives, and safeguards product and process integrity. Responsibilities include strategic planning, team leadership, and cross-department collaboration to promote quality excellence.   You will develop and implement the QA...

The Scientist, Process Development, is a critical position responsible for development activities associated with cell therapy process development and design at Fujifilm Diosynth Biotechnologies, California (FDBC).  This position provides hands-on support for all aspects of process development experimental design and execution, will be responsible for experimental process monitoring (data capturing), and process troubleshooting.  This position...

The Sr. Manager Quality Control (QC) Microbiology at Fujifilm Diosynth Biotechnologies California (FDBC) requires both leadership, technical, and business expertise. From a leadership perspective, the selected individual will need to lead, develop, and motivate staff. This requires a self-motivated, flexible, and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment. From a technical perspective, the selected individual will directly oversee QC Microbiology activities and deliverables to provide systems and processes to enable QC to complete department objectives. The Sr. Manager is...

The Automation Engineer 3, DSM Upstream will provide 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. This role focuses on supporting the delivery of DeltaV logic for Upstream process areas including Inoculum Lab, Media Preparation, Seed Culture, Large Scale Bioreactors, and Harvest. 

The Quality Assurance Operations Engineer DSM (Night) is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during the night shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that all DSM systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during your shift and resolution or mitigation of issues occurring during operation

The Sr. Engineer, Quality Assurance is responsible for establishing and maintaining a robust and efficient Technology Transfer program at the Holly Springs, NC site. This position is responsible for ensuring the quality and compliance of initial Technology Transfer (TT) activities and supporting the continuous improvement and ongoing success of the TT lifecycle. This position interacts cross-functionally with Manufacturing, Supply Chain, Quality Control, Process Sciences, Validation, and various Client functions to ensure Quality objectives and initiatives are effectively delivered in a phase compliant manner.

The Supply Chain Planner 3 role supports the project phase and operations of GMP Purchasing and Supply Chain Planning at FDBN to ensure that the right materials are available at the right time, in the correct quantity to support process validations and GMP production. This role supports the materials planning process and direct purchasing while liaising with both internal and external stakeholders on the status of material readiness. This role is

The Upstream Engineer/Scientist 2 will provide tech transfer support and technical oversight for a large-scale cell culture in monoclonal antibody manufacturing.

The Engineer / Scientist 3, Downstream MSAT will provide tech transfer support and technical oversight for large scale purification activities for Monoclonal antibody production.

This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required.  This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.  

The Associate Manager of Instrumentation & Controls (I&C) ensures the efficiency and operational reliability of the site instruments through an effective calibration process. This role sets the direction and manages the development of the I&C team as the site transitions from construction to operations. Additionally, this role assists with establishing efficient programs designed fit for future operations by utilizing current Good Manufacturing Practice (cGMP) / Good Laboratory Practice (GLP) knowledge, work scheduling, instrument calibration, repair, and troubleshooting. This role also provides day-to-day oversight and development of the I&C team. 

Summary:  The Sample Management Analyst I, under general direction, will be responsible for performing routine and non-routine support of samples submitted to the Quality Control (QC) Laboratory for evaluation. This position works as part of the Sample Management team to manage the receipt, organization and inventory of samples from manufacturing, clients, other Fujifilm facilities and third parties. The Sample Management Analyst I arrange sample shipments for outsource testing and shipments to Clients or other facilities and controls dispensing of samples...

The Tech 2, Instrumentation & Controls (I&C) is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility-wide equipment, and facility systems through effective Preventive and Corrective Maintenance and Calibration practices and know-how.