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The Director Quality Operations is responsible for QA oversight of CGMP manufacturing operations and areas at one of our manufacturing facilities at FDBT. Lead the Quality Operations organization to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders. Direct all QA on-the-floor (QAOTF), batch record review (BRR), and product disposition activities including QA review and approval of any associated deviations, CAPAs, and change controls to meet established targets for right first time execution and on-time delivery. Ensure products are manufactured to meet all CGMP regulatory...
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 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 Manufacturing Compliance Coordinator II assists with the tracking, coordination, and closure of Manufacturing CAPAs, change controls and deviations, and assists in supporting the timely release and disposition of batches and other post-execution activities.
The Engineer II functions within a team based organization to actively address complex cGMP manufacturing issues. The individual is responsible for analyzing process technologies in support of new project proposals and assist in the technical transfer into the manufacturing group. This individual must work in a collaborative manner coordinating the transfer of biological drug processes from process development (internal or client) groups in a CMO environment.
The Associate Director of QC Microbiology will provide strategic, technical, and operational leadership for QC Microbiology related activities. The individual will proactively identify and implement industry standard methodologies for Quality Control Microbiology Laboratories. Such efforts are related to rapid microbiological methods, media simulations and inspection requirements, gowning qualifications, aseptic operator qualifications, facility sanitization and cleaning, investigation assistance and continuous improvement plans.
The Manufacturing Technician III will work directly with a range of technologies.
The Senior Automation Engineer 2, MES provides support to Drug Substance Manufacturing (DSM). 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 leads projects and handles complex changes while coordinating with other internal and external groups.
The Manufacturing Technician III will work directly with a range of technologies. Dependent upon assignment, the range of technologies exposed to will be:
The EHS Specialist, under the supervision of the Sr. Manager, Biosafety & EHS, will be responsible for assisting in helping develop various safety and compliance programs at Fujifilm Diosynth Biotechnologies Texas (FDBT). Programs include occupational health and safety, fire safety, emergency response, management of hazardous and other special wastes, industrial hygiene, respiratory protection and environmental programs within the scope of EHS.
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 Manufacturing Technician II work directly with a range of technologies.
TheQuality Assurance Supervisor, Document Controlwill be responsible for...
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 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 Manufacturing Technician II work directly with a range of technologies.
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 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 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...
QC Instrumentation Specialist, Quality Control is an individual contributor supporting the quality control analytical, microbiology and operations teams. The candidate must have advanced knowledge of instrument lifecycle from procurement through validation for both direct and indirect GMP impact systems. The candidate must have strong GMP experience with an emphasis on instrumentation as it pertains to QC laboratories. Experienced with a wide variety of instrumentation and their distinct maintenance and qualification needs. Must be able to quickly adapt and learn new instrumentation and processes. The position requires strong technical expertise, leadership, and project management...