The QA – Supervisor - Compliance, will be responsible for the leading the compliance team with the management, metrics, and closure of CAPAs, Change Controls, Deviations, and Events.  The Supervisor will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.   

The QA Validation Specialist will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, and discrepancies for Quality Assurance.  The QA Validation Specialist will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance. 

The Senior Commercial Development Director – Drug Product will work with the VP Commercial to co-develop and execute commercial strategies aligned with FDB budget/growth plans in a specific territory or technology area.     This is a global position that will support all four sites (Raleigh, NC, College Station, Texas , Billingham, United Kindgom, or Hillerod, Denmark ). This position can be based at any of our locations around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site.

Summary The Sample Receipt Analyst I, under general direction, will be responsible for performing routine and non-routine support of samples submitted to the Quality Control (QC) Laboratory for evaluation.

Summary: The Quality Control Supervisor - Microbiology under general direction, will be required to plan, organize, direct and evaluate the routine activities of the Quality Control staff and laboratory functions to ensure the safety and reliability of products produced in compliance with The Company Quality and various regulatory requirements. In addition, the QC Supervisor will be responsible for performing routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory.  Candidates for this position must have experience in Microbiology and Environmental Monitoring (EM) in a regulated pharmaceutical setting. Strong candidates will have a working knowledge of additional QC functions in a regulated pharmaceutical setting.   Other responsibilities may include but are not limited to staff hiring, supervision, coaching, discipline and performing annual review assessments. Duties include reviewing data and problem solving in support of microbiological analysis.  Additional responsibilities may include supervision of specified chemical or biological testing.   The Quality Control Supervisor (Microbiology) candidate will also be involved in method development, method validation, method transfer and routine testing for incoming, in-process, release and stability testing on finished product, critical reagents and raw materials, as needed.    In the absence of other supervisory staff they will provide guidance to other groups within the QC organization.

Summary:  The Downstream Process Development Associate Principal Scientist functions in a supervisory role in the Downstream Process Development Group, actively engaged and engaging others in process development within a team based PD laboratory. The individual will independently lead customer projects and is expected to complete technical assignments through the self-sufficient design, execution and interpretation of complex experiments. The individual will be expected to significantly contribute to the technical growth and mentorship of the Downstream Process Development group, suggest new areas for development, present his or her own original ideas and research findings, and demonstrate a solid theoretical understanding within their own scientific discipline. 

Summary: The primary job responsibilities are preparing media according to strict quality standards and providing exceptional customer service. Safely operate processing equipment including autoclaves and pressurized tanks per procedure and report any issues. Work effectively and efficiently in a team-oriented environment to keep Media Prep operations running smoothly. Interact with customers, vendors, suppliers, and internal departments to improve safety, maintenance, efficiency, and productivity. Report any training or policy deficiencies and identify opportunities to improve procedures and operations. Adhere to and improve department SOPs, quality compliance GXPs, GMPs, GLPs, and other established procedures. Identify and support service delivery improvements to increase customer satisfaction.

The Assistant Scientist is an entry level position within each of the Process Development groups. The individual will learn and assist in the development and characterization of customer programs, and technology transfer to the manufacturing and/or Quality control group as appropriate. This individual will be expected to require training on laboratory instrumentation and then use instrumentation to perform elementary lab experiments and document results appropriately.

Summary:  The Information Technology Lab Engineer serves as the IT support for Quality and/or Laboratory Information Systems.

Summary:  The Manufacturing Process Engineer II 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 Bio-Manufacturing 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 Technology for adherent and suspension culture, Dispensing and Mixing and Buffer Preparation, Chromatography, Tangential Flow Filtration, various filtration technologies, cCentrifugation, and Bulk Fill.  This position will also create training programs and perform training for manufacturing technicians in the unit operation categories.

Summary:  Under limited supervision of the Sr. Manager, Materials Management, the Materials Specialist II is responsible for the accurate receipt, verification, record keeping, distribution, and shipment of materials and goods.

Summary:  The Manufacturing Technician III and 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: - Upstream Unit: - Single-Use Cell Culture Vessels/Bioreactors up to 2000L - Bacterial Fermentation Culture Vessels up to 2000L - Alpha Wasserman Continuous Flow Centrifuges - Disposable Magnetic Mixing Bags and Totes - Cell Expansion and Propagation - Banking/Cryopreservation of Cell Lines and Viruses - Hyperstack, Cellstack, and other Adherent Cell Technologies - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Downstream Unit: - Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration - Medium to Large-scale Chromatographic systems (ÄKTA). - Pre-Packed Columns from 1L to 100L - Single use mixing systems (Pall & GE) - Single Use connectivity types such as GE DAC and Colder AseptiQuik - Bulk filling - Aseptic process simulation and drug product filling - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Buffer Preparation Unit: - Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures - Integrity testing of filters

  Summary:  The Manufacturing Technician I and II work directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following: - Upstream Unit: - Single-Use Cell Culture Vessels/Bioreactors up to 2000L - Bacterial Fermentation Culture Vessels up to 2000L - Alpha Wasserman Continuous Flow Centrifuges - Disposable Magnetic Mixing Bags and Totes - Cell Expansion and Propagation - Banking/Cryopreservation of Cell Lines and Viruses - Hyperstack, Cellstack, and other Adherent Cell Technologies - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Downstream Unit: - Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration - Medium to Large-scale Chromatographic systems (ÄKTA). - Pre-Packed Columns from 1L to 100L - Single use mixing systems (Pall & GE) - Single Use connectivity types such as GE DAC and Colder AseptiQuik - Bulk filling - Aseptic process simulation and drug product filling - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Buffer Preparation Unit: - Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures - Integrity testing of filters

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.

Summary The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations.  This individual will supervise a team of employees directly or indirectly in these production process units.

Summary: The Associate Scientist - Upstream Process Development will assist in the development and execution of experiments for the development, optimization, and characterization of  cell-based and viral vaccine processes and will be involved in experimental design, data analysis, and interpretation.  This individual will assist the  Process and Analytical Development  Teams  to drive processes  towards manufacturing processes   for multiple viral projects and provide technical support for associated regulatory filings.  The individual should have familiarity with a range of cell-based and viral vaccine production technologies, including cell and virus expansion, infection, scale-up, harvest and filtration technologies.The successful candidate will also be experienced in basic laboratory techniques.  

Summary:  The Upstream Manufacturing Technician II will work directly with cell culture and viral propagation techniques, buffer and equipment preparations, cell culture and bioreactor operation, bacterial and fermentation operations, and aseptic technique following GMP procedures.

Summary: The Quality Control Analyst position, under general direction, will be responsible for performing review of routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory.  The data reviewer is responsible to ensure activities are reviewed in an efficient and cGMP compliant manner.

Summary: The Quality Control Analyst position, under general direction, will be responsible for performing review of routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory.  The data reviewer is responsible to ensure activities are reviewed in an efficient and cGMP compliant manner.

Our work with a myriad of biopharma companies means each project we work on brings a unique set of challenges. As Program Manager, you are the key link between our customers and our FDB team. You have the uncanny ability to work and build relationships with clients and internal cross-functional teams alike, are an effortless communicator, and can quickly get up to speed on our technology, bringing deep knowledge that will serve as the backbone for the project. You have great EQ, are the most organized person on the team, and are skilled at navigating ambiguity.   As the critical point of contact for our partners, our Program Managers are FDB’s biggest ambassadors. You represent our company: our mission of advancing tomorrow’s medicine, our passion for collaborating with our partners for life, and our dedication to seeing every project through with the highest amount of integrity and impact. If you want a high-visibility, cross-discipline, intensely collaborative position with undeniable importance, apply today.