Overview We are looking for a Director of Procurement, who will join our journey to establish the largest end-to-end cell culture CDMO facility in North America. You will be responsible for setting the direction and managing a central workstream in a $2 billion global project. As the Director of Procurement, you will have the strategic role of developing world-class procurement processes and frameworks. You will be responsible for managing this function and work closely with Finance, Legal, workstreams and 3rd parties to ensure procurement activities are carried out in accordance with company standards. We offer the possibility of building and leading a visionary business-driven team while utilizing your previous experience and skills within strategy, processes, and negotiation to ensure functional leaders are equipped with the knowledge to perform their procurement related activities. External US The work we do at...

Overview 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 FDB and help manufacture the next vaccine, cure, or gene 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. We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutions   to our customers...

Overview Summary :   The Quality Control Logistics Lead will be responsible for coordinating and overseeing all aspects of Quality Control (QC) equipment procurement, installation, and qualification.  This position will require the candidate to work closely with QC, QA, Validation, Engineering, and Facility staff members to coordinate and track all activities required to bring QC equipment into a GMP compliant state.   External US Essential Functions: Liaison between the QC Department and Capital Projects Team Coordinate and oversee annual PM calibrations for QC equipment New equipment induction into Blue Mountain Ram (BMR); submit work orders in BMR Work with Metrology to facilitate monthly calibration of QC equipment Generate and manage Change Controls for new equipment installations, equipment relocation, and software upgrades as required Assist with Equipment Out of Tolerance (OOT) and missing portable...

Overview The Senior Automation Engineer is a mid-level position in the Automation Engineering department of FDBU. This position will directly report to the Associate Director, Engineering, but may also have a functional reporting relationship to a senior colleague on a project to project basis. External US Senior Automation Engineer is a mid-level position in the Process Automation Engineering group of FDBU.  The primary purpose of this position is to provide field equipment support which includes diagnostics/troubleshooting support for the manufacturing, development, and facilities controls and monitoring systems. Under minimal supervision, the Senior Automation Engineer is responsible for the day to day manufacturing control system operations and troubleshooting. The troubleshooting will include doing wire signal tracing, reading wiring schematics and being able to determined I/O communication failures. In addition to...

Overview Summary:   Our Capital Project team in College Station, Texas is expanding and we are looking for a Senior Project Engineer  to ensure deliverables for his/her respective projects are well managed and in line with their stakeholders and company expectations. We are looking for a Senior Project Engineer who can help to plan projects and establish the criteria by which project success will be measured. The successful candidate will be responsible for establishing project inspection criteria, coordinating the review of project designs and ensuring the proper implementation of project elements. If you are a detail-oriented professional with over 10 years’ experience in project management and engineering, we encourage you to apply for this position. External US Essential Functions: Collaborate with other Engineers and staff to create more efficient methods and maintain profitability Develop the specifications for...

Overview The Downstream Equipment Engineer will ensure that the downstream process equipment deliverables from Fujifilm and from EPCM provider are timely and in the required quality. You will act as driver of the process equipment activities and must be able to, proactively, facilitate cross organizational interaction with external EPCM providers and use your extensive experience from a similar role in large pharma/biotech projects. We are looking for someone with positive energy, entrepreneurship, and courage to empower and inspire others. You will join an organization with focus on growth, you will have a steep learning curve but most essential there is a focus on people first and what you can bring to the table. We have a diverse workplace for people driven to make a difference. External US 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...

Overview Summary :   The Manufacturing Process Engineer I – is an entry-level position in the manufacturing    department in support of the drug product life cycle located at the Texas Bio Manufacturing Facility in College Station, Texas.  This position will report directly to the Sr. Manager DP Manufacturing but may also have a functional reporting relationship to a senior colleague on a project to project basis. Works independently, and with colleagues, to provide expertise and assistance for the design, development, standardization and maintenance of an operational filler machines utilized in the aseptic fill for drug product.  This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit.  Operational biotechnologies include:  Isolators and their use in the single use technology, visual inspection and work under aseptic and clean rooms. This position will also require to aseptically gown,...

Overview Senior Automation Engineer is a mid-level position in the Project Automation Engineering group of FDBU.  The primary purpose of this position is to provide technical direction and project coordination for automation projects, including new equipment integrations, existing equipment migrations, and continuous improvement projects. External US Senior Automation Engineer is a mid-level position in the Project Automation Engineering group of FDBU.  The primary purpose of this position is to provide technical direction and project coordination for automation projects, including new equipment integrations, existing equipment migrations, and continuous improvement projects. Under minimal supervision, the Senior Automation Engineer is responsible for supporting the change management, design, procurement, development, FAT/SAT, installation, qualification, and start-up of automated systems in accordance with FDBU...

Overview Summary :   Our Capital Project team in College Station, Texas is expanding and we are looking for a Project Engineer to ensure deliverables for his/her respective projects are well managed and in line with their stakeholders and company expectations. We are looking for a Project Engineer who can help to plan projects and establish the criteria by which project success will be measured. The successful candidate will be responsible for establishing project inspection criteria, coordinating the review of project designs and ensuring the proper implantation of project elements.  External US Essential Functions:  Collaborate with other Engineers and staff to create more efficient methods and maintain profitability. Develop the specifications for equipment, infrastructure and systems that are required for each project. Create/maintain the frame work used to develop and monitor project metrics and manage the...

Overview The Manufacturing Process Engineer II (Validation) works independently and with colleagues to provide expertise and assistance for the design, development, standardization and maintenance of an operational biotechnology utilized in the manufacture of proteins and drug substances. This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit. Operational biotechnologies include: Fermentation, Cell Culture/Single Use Technology, Filtration, Centrifugation and Chromatography. Core manufacturing technologies include Weigh and Dispensing, Mixing and Buffer Preparation, Parts washing and Sterilization, and Homogenization. External US The Manufacturing Process Engineer II (Validation) works independently and with colleagues to provide expertise and assistance for the design, development, standardization and maintenance of an operational biotechnology...

Overview Summary :  The Manufacturing Process Engineer I position is an integral part of the Manufacturing Technical Operations department, supporting Gene Therapy manufacturing at the National Center for Therapeutics Manufacturing (NCTM) and the Flexible BioManufacturing Facility (FBF200), located in College Station, Texas.  This position will report directly to the Manager of Technical Operations, Gene Therapy Manufacturing. Works independently, and with colleagues, to provide expertise and assistance for the design, development, standardization and maintenance of an operational biotechnology utilized in the manufacture of a variety of gene therapy, protein, and other types of drug substances.  This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit.  Operational biotechnologies include:  Isolators and biosafety cabinets and their use in cell propagation, Cell Culture/Single Use...

Overview Summary :   The Material Specialist SAP Lead is responsible for the support of FDBT projects by leading the warehouse operation teams in the execution of SAP.  This role will focus on training all warehouse positions on the correct operation of SAP and day to day scanning of all material movements.  Emphasis will be placed on the understanding of why certain transactions are executed and the continuous improvement of the Standard Operating Proceudures.  This role will also be involved with various aspects of the audit process and any requested information from the SAP system.     External US Essential Functions: Review and improvement of SAP training for warehouse operation staff. Author and review of current Standard Operating Procuderes for accuracy and adherence. Work directly with SAP Analyst staff to ensure all SAP entries are accurate and timely and meet the associated requirements on a daily,...

Overview 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. External US Essential Functions:  Applies scientific and cGMP manufacturing expertise to research and resolve issues in the technology transfer and implementation of client specified manufacturing processes for biologics including viral based products and vaccines. Leads multiple overlapping cross-functional technology transfer teams that include client technical staff and internal process...

Overview Summary :   The Engineer I 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. External US Essential Functions:  Assists in applying scientific and cGMP manufacturing expertise to address issues in the technology transfer and implementation of client specified manufacturing processes for biologics including viral based products and vaccines. Serves on cross-functional technology transfer teams that include client technical staff and internal process development and manufacturing teams. Assists in the identification...

Overview Summary : The Sr. Manufacturing Process Engineer is a mid-level position in the Manufacturing Technology Operations department in support of either the SATURN mAb or Gene Therapy manufacturing facilities located at the Texas BioManufacturing Facility – 100 (TBF – 100) or the Flexible Biomanufacturing Facility - 200 (FBF-200) respectively in College Station, Texas.  The SATURN Platform utilizes entirely single use technology and is a multi-stream, multi-product facility that manufactures clinical and commercial products. The Gene Therapy operations at FBF-200 also utilizes single use technology in support of COVID-19 vaccine candidate manufacturing. As a CDMO, customer liaison is a vital part of our business and the Technical Operations team act as the point of contact for our customers during manufacturing execution.  This position will report directly to the Manager, Technical Operations, but may also have a functional reporting relationship to a...