The Automation Engineer 2, DSM - CSV will provide support to the Drug Substance Manufacturing (DSM) facility. This includes preparing validation  documentation, contributing to the qualification of Drug Substance Manufacturing (DSM) GxP Automation Computerized Systems, and being a part of Automation on-call support as needed. This role will partner with other departments locally and other sites to align strategies and procedures. This role will be responsible for ensuring that all DSM GxP Automation Computerized Systems are...

The Quality Assurance (QA) Operations Supervisor, will be responsible for the overall performance of the QA group.  The supervisor will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.     Reports to                Senior Manager, Quality Assurance

As an upstream supervisor, you’ll lead and inspire a team of manufacturingassociates, supporting the start up of a new large scale cell culture

The Sr Automation Engineer 1, 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

The Manufacturing Technician IV will work directly with a range of technologies. The Technician IV level provides an opportunity to stay on the technical track, or work towards a supervisory path. Dependent upon assignment, the range of technologies may include any of the following:

The Instrumentation & Controls Technician 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 knowhow. While in project phase, the schedule will be M-F during normal business hours.  Upon transitioning to operations, this position will transition to the appropriate shift that will be defined prior to the transition. You will join an organization focusing on growth, people, and a steep learning curve as well as a diverse workplace with people driven to make a...

This position reports to the Process Engineering Manager, Upstream in support of the Process Equipment team for the Galaxy project, a greenfield construction project in Holly Springs, NC.  The initial assignment is to assume the Responsible Engineer role for the Seed Train unit operations.   As the site moves into commercial operations circa 2025, this position is planned to continue as a Process Engineering role supporting commercial operations, technology transfers, and small capital projects related...

The Head of Global Program Management (VP) is responsible for leading the Global Program Management team in the Manufacturing Sciences organization to ensure timely manufacturing campaign starts of robust operations and is a member of the global Operations Leadership Team.  Other projects may be managed as well, for example new technology implementations or special studies carried out within the manufacturing environment.  Deployment of standard work processes and developing the global culture to embrace them is critical to success, and measured by low stress, highly efficient project teamwork.  Active participation in global planning, and the development of...

The Manufacturing Supervisor works as part of the Manufacturing team to deliver on goals to generate high quality materials that can be used both in the clinic as well as commercial.  This position will contribute to the successful delivery of released product in support of clinical trials and commercial requirements.  The Manufacturing Supervisor will work in different activities including manufacturing processes, facility cleaning, document review, inventory control and materials management.  The position will also provide manufacturing processing input for the design and operation of computer systems (MES, ERP, LIMS, QMS, EMS).  The candidate will also understand the...

The Microbiology IV will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FUJIFILM Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.  This position is a pivotal role to either a technical career path as a Microbiologist IV or a managerial career path as a Lead for the team, and a successful individual in this role will lead the team regardless of the career path they decide to pursue.  

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 our new FDB facility in Thousand Oaks, CA and help manufacture the next cell 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 we call Genki.  The Manager Quality Control Analytical will manage a group of Quality Control activities at...

The QC Operations Manager will manage, maintain, and oversee the day-to-day operations of the Quality Control Coordinators, Sample Management, and Stability Coordinators.  The Quality Control Operations Manager will oversee and manage staff in a multi-functional support role.  This position will require the QC Operations Manager to supervise QC employees staffed in the following areas:  QC Project Coordinators, Sample Management, and Stability Coordinators. The position will also require frequent communication with the Analytical Development and Assay Method Transfer groups to coordinate and schedule method qualification activities.  The QC Operations...

The QC Supervisor, Cell Biology will be responsible for coordinating the installation and qualification of new analytical equipment in support of GMP release and stability testing.  The Cell Biology/Immunology Supervisor will lead tech transfer activities of qualified cell based and immunological methods from designated donor laboratories.  The Supervisor will play a pivotal role in selecting qualified personnel to staff the QC Cell Biology laboratory.   

The Senior Computerized Systems Validation Engineer, under general direction, will be responsible for oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems.

The QC Chemistry Sr. Analyst 1 works with limited direction to execute QC analytical chemistry methods used in biological product manufacturing, including chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The QC Chemistry Sr. Analyst 1 adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identifies laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs). The role is primarily responsible for executing routine analytical methods in...

The Sr. Specialist 2, QC Instrumentation manages routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program with minimal supervision. This role ensures compliance with Data Integrity standards in alignment with regulatory guidelines and company policies. The Sr. Specialist executes and monitors the performance of routine maintenance, performs periodic reviews to ensure continued compliance, and leads the identification and correction of deviations. The role provides guidance to stakeholders and addresses issues related to QC analytical instruments. It also includes periodic on-call and weekend support as needed

The Project Manager 2 is responsible for collaborating with internal and external stakeholders, including but not limited to Environmental, Health & Safety(EHS), Maintenance, contractors, vendors, and clients. This role is responsible to handle administrative aspects of the project from start to completion, track and monitor the project status and milestones, and ensure projects meets all standards, timelines, and budgets.