Overview We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.     The Contract Quality Assurance Technical Specialist (Supplier and Materials Management ) position is a technical professional that is a recognized authority within their specialized field.  It provides execution of Quality System programs related to...

Overview We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients. Our manufacturing organization is searching for a Nightshift Downstream Production Manager. The DS Production manager is recognized as the subject matter expert with regard to manufacturing processes. The ideal candidate will Initiate and oversee...

Overview We are looking for a Head 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 Head 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 FDB has never been more...

Overview We are seeking a team of Senior Process equipment Engineers in our journey to establishing the largest End-to-End cell culture CDMO provider in North America but more importantly, someone who wants to be a part of the largest growth journey that we in Fuji Film have ever entered. Be a part of the future. Today. We offer the possibility of playing a central role in the Process Equipment work package in a a $2 billion global project. Your specialist focus could be on Upstream, downstream, media/prep, CIP/water etc. depending on your background. 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 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 create the next vaccine, cure, or gene therapy in partnership with some of the most...

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 of single-use process...

Overview Summary :   The Quality Assurance (QA) Supplier Quality manager will be responsible for leading the supplier quality team.  The manager will ensure all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility. External US Essential Functions: Leadership Provides direction to the validation team to ensure the organization is complying with local and global quality standards, regulatory requirements and partner commitments. Develop, motivate and lead direct reports towards achieving organizational and individual goals. Work collaboratively with management of other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles. Compliance QA representative to external suppliers Interface and coordinate with sister sites on supplier quality system, harmonization, and joint qualification...

Overview Summary : The Maintenance, Repair and Operationsm(MRO) Buyer Specialist under the supervision of the Facilities Support Supervisor is responsible for the buying, deliver and replenish spare parts, using the program Computerized Calibration & Maintenance Management System (CCMS/CMMS) in support of multiple manufacturing facilities such as 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). Primary responsibilities include managing the daily spare parts operations such as screening of incoming work orders, identification of parts requires, procurement of parts, equipment and specialized tools.   Scheduling of parts inventory control and monitoring of maintenance tasks performance. This position will interact with other maintenance and technical trades, such as manufacturing operators, engineers, calibrations...

Overview As a member of the Supply Chain organization, the Data Analyst/Steward – MDM is responsible for the creation and maintenance of item master material to support Fujifilm Diosynth Biotechnologies supply chain operations, ensuring business continuity, and accurate data quality. They will collaborate with business, operations, and technology stakeholders to utilize processes and workflows to build a strong data foundation for supply chain. Pioneer master data governance best practices with a focus in continuous improvement to promote growth and structure for daily supply chain operations. The Data Analyst/Steward – MDM will also be adaptable to assisting with business or IT projects to advise on master data topics and execute necessary activities. This is a contract position scheduled to last at least 12 months offering benefits. External US As a member of the Supply Chain organization, the Data Analyst/Steward – MDM is responsible for the...

Overview We are looking for a dedicated, result-oriented Senior Process Engineer to join our Engineering Sciences team. As a Technology Lead, you will be providing engineering technical leadership, and primarily designs, and specify new equipment for all Drug Substance (DS) processing equipment and utilities on the site. You will be a subject matter expert in technical investigations and in the technology transfer of new products/processes. You will champion transformation of engineering, manufacturing and facility technologies, participate in industry forums and provide technical engineering expertise for new processing equipment installations and modifications to existing equipment. We are looking for someone with positive energy, entrepreneurship and courage to empower and inspire others. You will join an organization focusing on growth, a steep learning curve and most importantly a focus on people and what you can bring to the table. External US...

Overview 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. External US Essential Functions:  Applies 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. Lead multiple overlapping cross-functional technology transfer teams that include client technical staff and internal process development and manufacturing teams. Identification of single-use process...

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 development and...

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 senior...

Overview 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. External US Essential Functions: Draft, implement and maintain warehousing procedures to include: receiving, quarantine, release, warehousing and logistics policies for GMP and Non-GMP material and supplies in a multi-client warehousing environment. Organize and conduct necessary training for warehousing operations. Create and maintain a qualified vendor list. Ensures proper function of equipment used to support warehousing operations. Receive, inspect, segregate and label incoming materials and ensure accurate inventory level to support manufacturing requirements. Perform system transactions and ensure the timely and accurate order fulfillment,...

Overview Summary :   The Lean Six Sigma (LSS) Project Lead is responsible for leading, managing, and delivering process improvement projects at Fujifilm Diosynth Biotechnologies, Texas in order to achieve annual goal delivery, revenue plan, and long-term strategic initiatives.  With minimal supervision, the incumbent will provide on-going advice, coaching, mentoring and direct support to staff and managers (particularly Green and Yellow Belt candidates) on Continuous Improvement processes and practices across the business as required.  Additionally, this individual will be expected to deliver measurable cost reductions as a result of deploying Lean Six Sigma (LSS) tools both directly and indirectly through training delivery and coaching in LSS tools to others in the business. External US Essential Functions: Initiate and lead continuous improvement projects that improve end-to-end business value and drive significant business impact. Work...