Summary:  The Senior Scientist Upstream will provide technology leadership for the Upstream Process Development for a variety of technical platforms, provide technical support for associated regulatory filings, and improve processes or propose modifications to equipment to deliver improvements.  The Senior Scientist will act as technical lead for the development and optimization of novel cell culture and bioreactor processes for multiple viral projects.  Responsibilities include cell line selection, process development, process scale-up, and tech transfer.  Requires hands-on execution of process optimization, cell culture media, along with process characterization of cell culture production processes that can be transferred to the Manufacturing group as well as external collaborators. 

Summary:  The Process Sciences - Associate Scientist/Engineer, under general direction, functions within a team based organization to actively address cGMP manufacturing issues. The individual is responsible for analyzing process technologies to assist in the technical transfer of new processes into the manufacturing group. This individual must work in a collaborative manner to assist the transfer of biological drug processes from process development (internal or client) groups in a CDMO environment.

Summary:  The Senior Engineer functions independently and productively 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 takes responsibility for 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.

Summary:  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.    

Summary:  The Materials Management Specialist is responsible for drafting and implementing supply chain management procedures governing the receiving, warehousing, ordering, shipping and internal distribution of cGMP (current Good Manufacturing Practices) and non-GMP materials.

Summary:  The Program Manager, with mentoring and support from the Head of Program Management and/or Associate Program Director or Program Director, will be responsible for the planning and delivery of programs from the point of contract signature (Scope of Work/Letter of Intent/Contract) to program delivery including technology transfer and taking a product/process from execution of a client commercial agreement or memorandum of understanding through process development and early stage clinical supply through program closure.  The Program Manager ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission (strategy and compliance).  The Program manager typically manages programs of shorter duration and/or fewer concurrent programs relative to a Associate Program Director.

  Summary:  The Facilites Engineer II, under the supervision of the Associate Director, Facility Engineering, will be responsible for performing various aspects of engineering, operational and troubleshooting support for facilities, utilities and process equipment including but not limited to bioreactors, fermenters, 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 boilers, water purification and distillation units, waste water treatment systems, etc. at the National Center for Therapeutic Manufacturing (NCTM), the Texas Biological Facility (TBF) and the Flexible Biological Facility FBF on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). This position will apply engineering principles to monitor the running condition of complex equipment, and use technical manuals, on-line resources and OEM representatives to maintain the equipment with a minimum of downtime. This position will also work closely with manufacturing resources, validation, QA/QC and maintenance/calibration technicians to help maintain complex process equipment operational and troubleshoot to identify issues when needed. This position will require involvement in the utilities and production processes to identify and implement process improvements using Change Control procedures as well as perform corrective and preventive actions using the CAPA system. This position will also support P&ID development, maintenance strategies development, equipment life cycle development, any software and/or hardware upgrades and equipment commissioning/qualification activities as required. This position may also assist in the identification of equipment of the proper type, size, materials, throughput, physical dimensions, required utilities and URS development for future projects. 

Summary:  Our Capital Project team in College Station, Texas is expanding and we are looking for a Project Manager to ensure deliverables for his/her respective projects are well managed and in accordance with their stakeholders and company expectations. The Project Manager will oversee the day-to-day of capital projects from simple scope equipment procurement to more complex scopes involving facility construction/modification, efficiency improvements, systems sustainability and quality/safety enhancement.

Summary:  The Scientist II independently designs, executes and interprets complex laboratory experiments and development activities with priorities set by supervisor/project lead to achieve project goals. The individual should display good technical knowledge and scientific understanding of downstream purification of viruses, proteins, and plasmid DNA as well as having knowledge of process development at both small and large process scales.

Our Automation team in College Station, Texas is expanding and we are looking for Automation Engineers to provide technical and operational support, execution of critical projects, installation, operation, maintenance and troubleshooting of FUJIFILM Diosynth Biotechnologies Texas, LLC automation systems to meet organizational goals and objectives. This position will also work closely with other operators, technicians, managers and engineers to maintain complex systems.

Summary: The Validation Specialist II, under direct supervision, will be responsible for drafting and executing protocols and preparing validation final reports for facilities, utilities, manufacturing and quality control equipment in a GMP environment.

The Validation Specialist III, under general direction, will be responsible for execution of individual validation projects. These projects may include drafting and execution of IQ, OQ, and PQ protocols for utility systems, process equipment, laboratory equipment, and process support equipment/systems across multiple GMP facilities, preparing validation summary reports for those systems and the development and approval of related lifecycle documentation.

Summary: The Validation Project Manager will be responsible for managing the execution of multiple validation related projects at FDBT facilities.

Summary: The Microbiology Analyst III will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. 

Summary: The Microbiology Analyst II will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. 

Summary: The Microbiology Analyst I will be responsible for assisting the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. 

Summary:  The Associate Director, Program Management, with mentoring and support from the Head of Program Management and/or a Program Director, will be responsible for the planning and delivery of programs from the point of contract signature (Scope of Work/Letter of Intent/Contract) to program delivery including technology transfer and taking a product/process from execution of a client commercial agreement or memorandum of understanding through process development and early stage clinical supply through program closure.  The Associate Program Director ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission (strategy and compliance).  The Associate Program Director typically manages programs of shorter duration and/or fewer concurrent programs relative to a Program Director.

Summary: The Director, Program Management will be responsible for the planning and delivery of programs from the point of contract signature (Scope of Work/Letter of Intent/Contract) to project delivery including technology transfer, and taking a product/process from execution of a client commercial agreement or memorandum of understanding through process development and early stage clinical supply through program closure.  The Program Director ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission (strategy and compliance). 

Summary: The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally.

Summary: 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.