Careers

Are you ready to grow your career?

People are the essence of any organization and at FUJIFILM Diosynth Biotechnologies our employees keep our company thriving. Our team consists of smart, diverse, passionate people who enjoy working in a stimulating environment with locations in Research Triangle Park, North Carolina, USA; College Station, Texas, USA, Billingham, United Kingdom and Hillerød, Denmark.

Grow Your Career

As we continue to grow, we look for qualified candidates for a variety of administrative, business, manufacturing, technical, and scientific career opportunities.  We offer a work environment that promotes individual responsibility and growth, a collaborative spirit, and an atmosphere that encourages learning and professional development.

Gender pay gap statement
At FUJIFILM Diosynth Biotechnologies we are committed to our people and ensuring that everyone no matter what their background or gender – has an opportunity to  develop. We are confident that our gender pay gap is not caused by men and women being paid differently to do the same job but is driven instead by the structure of our workforce. To view the full UK  site 2018 report: Gender Pay Gap Report 2018

 

Learn more about our CURRENT opportunities around the globe:

 

 

 


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Analytical Development – Scientist I

  • College Station, Texas

Summary: The Scientist I, under general supervision, will help FDBT to develop new methods to support clients and adapt client-specific methods to FDBT instrumentation as well as helping to qualify and/or validate them.

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Analytical Development – Technician I

  • College Station, Texas

Summary:

The Technician I, under direct supervision, will assist in the preparation, transfer and development of analytical methods for in-process, and finished product including release testing and testing of critical reagents.

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Associate Director of Program Design

  • Cambridge, Massachusetts, Research Triangle Park, North Carolina

The Associate Director of Program Design will be an expert in supporting Sales in acquiring new business, particularly from the Boston Area. They will lead technical discussions with potential clients projecting Fujifilm experience and expertise in microbial, mammalian, and gene therapy focus. They will author customer-tailed proposals in support of sales. This position is open to Boston, MA and RTP, NC. If the candidate sits in RTP, NC, they would need to support the Boston area and spend a few days a month in Boston. The job holder will be responsible for providing technical support to new customers, primarily located in the Northeastern United States.

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Associate Director of Program Design, Gene Therapy

  • College Station, Texas

The Associate Director of Program Design will be an expert in viral-vectors and gene-therapy engaging potential clients in support of sales. They will author customer-tailored proposals and act as the technical advisor to management on the latest trends in viral vectors and gene therapy. The job holder will be responsible for providing technical support with an emphasis on viral-vectors and gene therapy with the focus on the potential customers located in the United States and the development and production capabilities of Fujifilm’s Texas site.

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Associate Director, Downstream Process Development

  • College Station, Texas

Summary: The Associate Director is responsible for directing a group including upper level scientists to achieve project milestones and to provide senior technical and scientific leadership to the department. The individual assumes a managerial leadership role by setting standards, timeframes and priorities, interacting with other departments and handling some administrative, sales and marketing and managerial resources duties for the group.

The individual provides leadership for multiple projects and/or programs within the group to contribute to revenue generation.

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Associate Director, Program Management

  • College Station, Texas

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.

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Associate Director, Supply Chain – TBF 100

  • College Station, Texas

Summary: The Associate Director, Supply Chain – TBF 100 is responsible for delivering contracted product per the revenue forecast and as well as establishing the central production plan activities for the start-up of the new SATURN Project located at the Texas BioManufacturing Facility – 100 (TBF – 100) in College Station, Texas. This position is also responsible for inventory levels, material readiness, various monthly reporting, conveying company expenditures, and facilitating the contract process between internal customers and external parties as well as responsibility for implementing an Enterprise Resource Planning System (e.g., SAP) for the Texas site. The SATURN Project is a multi-product manufacturing facility using a single-use bioreactor platform with multiple Upstreams feeding the Downstream. SATURN is a high throughput mAb (monoclonal antibody) facility that will create a world class platform to support our customers’ clinical and commercial products

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Associate Principal Scientist – Analytical Method Transfer

  • College Station, Texas

Summary: The Associate Principal Scientist, Group Leader – Analytical Method Transfer will lead the AMT group and will directly oversee technical transfers, qualifications, and validations of analytical methods conducted at FDBT. Responsibilities will include ensuring the success of all protocol-driven analytical activities, delivery of project milestones, development of personnel, technical support, and operational excellence within the AMT group. This position will provide scientific leadership to manage the success of AMT analysts executing method transfers, qualifications, and validations, and will directly collaborate within the Analytical Development and Quality Control Departments to establish that analytical methods are fit for purpose to support cGMP biopharmaceutical manufacturing processes.

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Associate Principal Scientist – Innovation

  • College Station, Texas

Summary:

The Associate Principal Scientist Group Leader is responsible for managing a group of scientists as the initial supervisor in the Science and Innovation organization. The individual will actively participate and lead projects in innovation research and scientific collaborations and handle the administrative and supervisory duties for the group.

The Associate Principal Scientist independently applies scientific and/or cross-functional knowledge to achieve project goals and provide technical and scientific leadership within the department. The individual will lead innovation projects and is expected to assist with technical evaluation of new technologies with collaborators and the development of alternative analytical methods through self-sufficient design, execution and interpretation of complex experiments. The individual will suggest new areas for innovation, present his or her original ideas and experimental findings and demonstrate a solid theoretical understanding within Advanced Viral Therapeutics.

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Associate Scientist – Analytical Method Transfer

  • College Station, Texas

Summary: The Associate Scientist – Analytical Method Transfer (AMT) will function collaboratively and productively in a team devoted to ensuring the quality of effective analytical methods at FDBT. The individual should possess experience with several bioanalytical techniques that are used to assess viruses and proteins as well as strong technical writing skills.

The AMT group is a protocol-driven group which will primarily perform Tech Transfer, Qualification, and Validation of test methods coming out of the FDB analytical groups and transition them into our Quality Control group. The position will primarily focus on executing analytical method protocols, summarizing data, coordinating instrumentation needs, finalizing test methods and ensuring a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success. The candidate will be expected to follow cGMP documentation practices.

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Associate Scientist – Downstream Process Development

  • College Station, Texas

Summary:
The Associate Scientist – Downstream Process Development will assist in the development and characterization of scalable purification processes, and technology transfer to the manufacturing group as appropriate. This individual will have familiarity with a range of purification technologies including centrifugation, filtration technologies (TFF and depth), chromatographic separations and basic laboratory analytical techniques (SDS-PAGE, spectroscopy, pH/conductivity meters, etc.)

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Associate Scientist, Bioassay Development

  • Research Triangle Park, North Carolina

The Bioassay Development group is seeking an energetic Associate Scientist with protein chemistry experience to become an integral member of a high performing development team supporting process and formulation development groups. The successful candidate will primarily perform sample analysis using bioassay based techniques such as qPCR, ELISA or plate-based potency assays for the characterization and testing of recombinant protein pharmaceuticals.

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Automation Engineer

  • College Station, Texas

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.

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Automation Engineer

  • Hillerød, Denmark

Do you enjoy working with batch processes?
Then join a strong automation team at Fujifilm Diosynth Biotechnologies.

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Biocampus Estate Manager

  • Billingham, United Kingdom

Fujifilm Diosynth Biotechnologies based in Billingham, Stockton-on-Tees specialise in developing manufacturing processes for biologic drugs and offering stability studies to support customer drug substance and drug products.

With plants in Billingham UK, North Carolina and Texas USA and Hillerod in Denmark our global vision is to be the leading and most trusted global Contract Development and Manufacturing Organisation partner in the biopharmaceutical industry.

As we invest in expanding our UK site, a new position has arisen for a Biocampus estate manager within our site engineering team.

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Business Application Lead

  • Billingham, United Kingdom

Fujifilm Diosynth Biotechnologies based in Billingham, Stockton-on-Tees specialise in developing and manufacturing processes for customer’s biologic drugs and offering stability studies to support customer drug substance and drug products.

With plants in Billingham UK, Hillerod Denmark, North Carolina and Texas USA our Global Vision is to be the leading and most trusted global Contract Development and Manufacturing Organisation partner in the biopharmaceutical industry.

We have an exciting opportunity for a Business Application Lead to join our UK IT team.

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Business Development Manager (Biologics)

  • United States, West Coast

The Commercial Development Manager will identify, manage the initial qualification, and close through the signing of a letter of agreement for new business, concentrating on Biologics.

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Calibration Technician II

  • College Station, Texas

Summary: The Calibration Technician II is responsible for maintaining and improving the cGMP Calibration Programs at the Fujifilm Diosynth Biotechnology Texas (FDBT) facilities in College Station Texas. This includes complex bio-pharma processing equipment such as Mobile Bio Processing Rooms, Mobile Clean Rooms, Bioreactors, Fermenters, centrifuges of various sizes and process, filtration skids, columns, critical water systems and a variety of analytical and test equipment.

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Calibration Technician III

  • College Station, Texas

Summary: The Calibration Technician III is responsible for maintaining and improving the cGMP Calibration Programs at the Fujifilm Diosynth Biotechnology Texas (FDBT) facilities in College Station Texas. This includes complex bio-pharma processing equipment such as Mobile Bio Processing Rooms, Mobile Clean Rooms, Bioreactors, Fermenters, centrifuges of various sizes and process, filtration skids, columns, critical water systems and a variety of analytical and test equipment. This is a key position in the readiness of the instrumentation and equipment for the new Texas Bio-Manufacturing Facility as well as maintaining the current operation of the existing facility.

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Cell Biology Analyst I

  • College Station, Texas

Summary The Cell Biology Analyst I, under general direction, will be responsible for performing routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory.

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Cell Biology Analyst I

  • College Station, Texas

The Cell Biology Analyst I, under general direction, will be responsible for performing routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory.

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Cell Biology Technician

  • College Station, Texas

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

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Commercial Development Manager

  • Cambridge, Massachusetts, Research Triangle Park, North Carolina

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 Commercial Development Manager will identify, manage the initial qualification, and close through the signing of a letter of agreement for new business.

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Commercial Development Manager

  • Hillerød, Denmark

We have an opportunity for a Commercial Development Manager to join the Company. The role requires significant interactions with senior technical and commercial client contacts.

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Commercial Process Engineer II

  • Research Triangle Park, North Carolina

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 Commercial Process Engineer II is part of the Manufacturing Organization. The individual in this role works under general supervision with the latitude for independent judgment. This role provides day-to-day leadership and oversight for the monitoring of commercial product(s), as well as continuous improvement around production, compliance and safety for supported programs. This position requires an understanding of core manufacturing and operational technologies for the manufacturing unit, which include: Fermentation, Cell Culture/Single Use Technology, Filtration, Centrifugation and Chromatography. Additionally, this position will be responsible for supporting deviation investigations, internal and regulatory document updates, as well participating in client and regulatory audits.

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Director of Program Design

  • Cambridge, Massachusetts, Research Triangle Park, North Carolina

The Director of Program Design will be an expert in supporting Sales in acquiring new business, particularly from the Boston Area. They will lead technical discussions with potential clients projecting Fujifilm experience and expertise in microbial, mammalian, and gene therapy focus. They will author customer-tailed proposals in support of sales. This position is open to Boston, MA and RTP, NC. If the candidate sits in RTP, NC, they would need to support the Boston area and spend a few days a month in Boston. The job holder will be responsible for providing technical support to new customers, primarily located in the Northeastern United States.

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Director of Program Design, Gene Therapy

  • College Station, Texas

The Director of Program Design will be an expert in viral-vectors and gene-therapy engaging potential clients in support of sales. They will author customer-tailored proposals and act as the technical advisor to management on the latest trends in viral vectors and gene therapy. The job holder will be responsible for providing technical support with an emphasis on viral-vectors and gene therapy with the focus on the potential customers located in the United States and the development and production capabilities of Fujifilm’s Texas site.

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Director Process Development Management

  • College Station, Texas

Summary: The Director of Operations is responsible for the development & maintenance of systems and ways of working within process development. In addition the individual will be responsible for the development and subsequent management of a Technical Project Leadership function. The individual assumes a managerial role by setting standards, timeframes and priorities, interacting with other departments. The individual provides leadership within the process development group to contribute to revenue generation.

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Director, Program Management

  • College Station, Texas

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).

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Document Control Lead

  • College Station, Texas

Summary: This is an experienced role with in-depth and specialized knowledge of cGMP documentation. This position can largely function with minimal or no supervisory oversight for routine duties such as document routing, tracking document review and approval process, maintaining Document Control KPIs, etc. Additionally, the Document Control Lead will establish and modify comprehensive document control systems that are compliant with cGMP requirements, as well as assist in preparation for and help with quality audits. This role provides technical knowledge and leadership for the team and may act as a Quality representative in certain situations when necessary.

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Document Control Specialist I

  • College Station, Texas

Summary: The Document Control Specialist I, under general direction, will be responsible for routing and archiving company controlled documents. Documents include but are not limited to; Standard Operating Procedures (SOPs), production records (PRs), training records, validation documents, and policies.

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Downstream Manufacturing Technician I

  • College Station, Texas

Summary: The Downstream Manufacturing Technician I will work directly with viral purification (either whole particle or split particle), continuous flow centrifuge operation, and sucrose gradient separation, techniques for filtration and chromatographic separation (i.e. column chromatography and HPLC) and viral inactivation.

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Downstream Manufacturing Technician II

  • College Station, Texas

Summary: The Downstream Manufacturing Technician II will work directly with a range of purification technologies and equipment including: filtration technologies (TFF and depth), chromatographic separations (Single Use GE AKTA systems), viral inactivation, and centrifugation following aseptic techniques and procedures in a cGMP environment.

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Downstream Manufacturing Technician III

  • College Station, Texas

Summary: The Downstream Manufacturing Technician III will work directly with a range of purification technologies including: filtration technologies (TFF and depth), chromatographic separations (Single Use GE AKTA systems), viral inactivation following aseptic techniques and procedures in a cGMP environment.

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Drug Product Operations – Technician I

  • College Station, Texas

Summary: The Drug Product Operations Technician I will work directly with the Vanrx SA25 Vial Filling Isolator, following aseptic techniques and procedures in a cGMP environment.

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Drug Product Operations – Technician II

  • College Station, Texas

The Drug Product Operations Technician II will work directly with the Vanrx SA25 Vial Filling Isolator, following aseptic techniques and procedures in a cGMP environment.

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Drug Product Operations – Technician III

  • College Station, Texas

The Drug Product Operations Technician I will work directly with the Vanrx SA25 Vial Filling Isolator,. following aseptic techniques and procedures in a cGMP environment.

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Drug Product Operations – Technician IV

  • College Station, Texas

Summary: The Drug Product Operations Technician IV will work directly with the Vanrx SA25 Vial Filling Isolator,. following aseptic techniques and procedures in a cGMP environment.

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Drug Product Operations Coordinator

  • College Station, Texas

The Drug Product Operations Coordinator assists the Drug Product Manufacturing team to ensure Right-First-Time execution on the GMP manufacturing floor by developing and driving systems for readiness, compliance, and performance of new knowledge. The Drug Product Operations Coordinator will assist in supporting the timely release and disposition of drug product batches and other post-execution activities.

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Drug Product Operations Process Engineer

  • College Station, Texas

The Drug Product Process Engineer is a mid-level position in the Drug Product Operations department in support of the production of drug product in the Texas BioManufacturing Facility – 100 (TBF-100) and the Flexible BioManufacturing Facility – 200 (FBF-200) in College Station, Texas. Drug Product Operations utilizes a state of the art Aseptic Filling Workcell to provide scalable, flexible capacity for sterile injectable manufacturing. As a CDMO, customer liaison is a vital part of our business and the Drug Product Technical Operations team will act as the point of contact for our customers during manufacturing execution.

The individual in this position will work independently and with colleagues to provide expertise and assistance for the design, development, standardization and maintenance of the technology utilized in the manufacture of drug product. This person would become the subject matter expert on core manufacturing and operational technologies for the drug product manufacturing unit. Operational technologies include: Isolators in the preparation of components required for aseptic filling and gloveless robotic isolator technology in the aseptic filling of drug product.

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Equipment Engineer III

  • College Station, Texas

Summary: The Equipment Engineer III, under the supervision of the Associate Director, Facility Engineering, will be responsible for life cycle development of new process and utility equipment for both critical upstream and downstream processes, as well as clean utility equipment in an advanced Bio-Technology facility. This engineering position will work with process development engineers, research scientists and clients in identification of equipment through development of the URS, for prototype, analytical and full scale production, for purchase and installation. The position will assist in identification of equipment of the proper type, size, materials, throughput, physical dimensions and required utilities.

The Equipment Engineer will support P&ID development; software and hardware requirements, streamline processes and participate in FATs and SATs for expeditious commissioning of equipment for the process. The Equipment Engineer III will also work with vendors and OEM through the functional design phase and traceability matrix confirmation of the equipment proposals and procurement. This position will support the various aspects of equipment procurement through initial engineering, maintenance and follow on support as well as validation and qualification. The job requires some degree of knowledge and experience with procurement and support for biotechnology equipment including fermenters, bioreactors, centrifuges, ultra-filtration skids, Chromatography skids, as well as support equipment such as incubators, ultra-low temp freezers and clean utilities.

This position requires intimate knowledge of the biotechnology processes, typical operations and the equipment used in such processes. This position may also be called upon to support utility systems (pneumatics, plumbing, electrical, chilled water), bio-waste treatment system, Quality Control (QC) laboratory critical equipment and building automation and environmental monitoring systems. Activities may also involve working with Validation, Operations and Quality Control personnel to troubleshoot and identify issues with equipment or processes.

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Facilities Engineer I

  • College Station, Texas

Summary: The Facilities Engineer I, 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.

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Facilities Engineer II

  • College Station, Texas

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.

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Facility Maintenance Technician

Summary: The Facilities Maintenance Technician I, under the supervision of the Facility Supervisor, will be responsible for performing various aspects of maintenance and support at one or more facilities at the Fujifilm Diosynth Biotechnologies Texas site, including the National Center for Therapeutic Manufacturing, (NCTM), and Building 100/Building 200. This is an entry level position for maintenance and support of the facility as well as the equipment and systems installed therein, including 200 to 500 ton air cooled chillers, air handlers and fan coil units, heat recovery systems, heating water and steam boilers, water filtration and distribution systems, waste water treatment systems, freezers, refrigerators, walk in cold rooms, split systems, temperature control systems, as well as chilled water systems and pumps, etc.

The Maintenance Technician I will assist other technicians in installation and intervention of new process equipment on arrival and assist with check out for new or currently installed equipment. The Facility Technician I will also be available to support maintenance in other areas as needed and requested by work orders, etc. As an entry level position, there is an expectation of learning and improvement of maintenance and other skills and knowledge including environmental, safety and health regulations and cGMP procedures, etc.

The Maintenance Technician I will be expected to develop good electrical and mechanical skills to monitor the running condition of the above listed systems, as well as Building Monitoring Systems, Automation Systems, SCADA systems to monitor equipment associated with both process and building HVAC and refrigeration and freezer equipment. This position, with occasional supervision, will be expected to develop trouble shooting techniques using technical manuals, on-line resources and OEM representatives to maintain the equipment and systems. This position will also work closely with other operators, process and maintenance technicians and engineers to help maintain equipment and execute work orders. This position may also be called upon to support other utility and process systems (pneumatics, plumbing, electrical and chilled water), Quality Control (QC) laboratory equipment and building automation systems and EH&S.

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Film/Videography Intern – Summer 2020

  • Research Triangle Park, North Carolina

Fujifilm Diosynth Biotechnologies U.S.A., Inc. is searching for a Film student to assist in videography, scripting, and securing data for Industrial Training in our QC Department. The successful candidates will have completed their sophomore or junior year or higher.  We offer a supportive, collaborative teaching environment to develop our Interns’ skills and identify their career goals.  This is a great opportunity to gain invaluable experience working for an industry-leading biopharmaceutical contract manufacturing organization.

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General Accountant

  • Research Triangle Park, North Carolina

We are searching for a General Accountant for our RTP, NC location to perform one or more of the following accounting and/or payroll activities: checks and verifies records, prepares invoices and vouchers; posts ledger and general journal entries and/or balances accounts payable and accounts receivable records. Generates reports, conducts specialized research projects and responds to inquiries as required. May reconcile difficult accounts and is responsible for a complete and systematic set of transactions in a specific phase of accounting. The General Accountant participate in the company’s capex, payroll, receivables, payables and revenue recognition processes within established financial control policies and procedures.

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Head of Operational Excellence

  • College Station, Texas

Summary: The Head of Operational Excellence is responsible for leading, managing, and delivering the site portfolio of process improvement projects at Fujifilm Diosynth Biotechnologies, Texas in order to achieve the annual company delivery and revenue plan and longer term strategic initiatives. The incumbent will be responsible for leading and managing a team of full time black belts and part-time dedicated green belts commensurate with the size of the site.

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Head of Program Management

  • Research Triangle Park, North Carolina

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 Head of Program Management will lead, direct and manage program delivery at Fujifilm Diosynth Biotechnologies in order to achieve the annual company revenue plan whilst providing outstanding customer service for all clients from pre-clinical to commercial manufacturing.

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Intern

  • College Station, Texas

Summary: Fujifilm Diosynth Biotechnologies, Texas, Inc. is offering summer internships for college students majoring in Life Sciences or Chemical/Mechanical/Electrical/Industrial Engineering disciplines, with positions open in Process Development, Quality Assurance, Environmental Health & Safety, Validation, Manufacturing Technology & Support, IT, Accounting, and Manufacturing. The successful candidates will have completed their sophomore year or higher. We offer a supportive, collaborative teaching environment to develop our Interns’ skills and identify their career goals. This is a great opportunity to gain invaluable experience working for an industry-leading biopharmaceutical contract manufacturing organization. The Intern will work in direct contact with the department staff to assist with department specific duties as requested. Internships generally run from mid-May to August, but may vary. The dates will be determined between the intern, supervisor, and Human Resources.

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Internship Opportunities for Summer 2020

  • Research Triangle Park, North Carolina

Fujifilm Diosynth Biotechnologies R.T.P., Inc. is offering summer internships for college students majoring in Life Science or Chemical/Mechanical/Electrical/Industrial Engineering disciplines, with positions open in Process Development, Quality Assurance, Environmental Health & Safety, Manufacturing Technology Support and Manufacturing. The successful candidates will have completed their sophomore or junior year or higher. We offer a supportive, collaborative teaching environment to develop our Interns’ skills and identify their career goals. This is a great opportunity to gain invaluable experience working for an industry-leading biopharmaceutical contract manufacturing organization. This is only for interns interested in working in RTP, NC.

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Maintenance Technician I – Night Shift

  • College Station, Texas

Summary: The Maintenance Technician I, under the supervision of the Facilities Maintenance Supervisor, or designated supervisor will be responsible for performing various aspects of utilities, facilities and process equipment maintenance and support for the Texas Biological Facility (TBF), the Flexible Biological Facility (FBF) and the National Center for Therapeutic Manufacturing (NCTM) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT).

Primary responsibilities include various aspects of maintenance and support for facilities, utility equipment and biotech processing equipment.

This position will be required to use technical manuals, on-line resources and OEM representatives to maintain the equipment operational with a minimum of downtime. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory.

This position is for a night shift position after an appropriate training period with more technical staff.

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Manager, Accounting

  • College Station, Texas

Summary: The Accounting Manager is responsible for fiscal functions of the Company in accordance with generally accepted accounting principles and in accordance with financial management techniques and practices appropriate within the contract manufacturing industry. The Accounting Manager will be responsible for monitoring general accounting practices, budgeting, internal accounting controls, accounts payable and accounts receivable functions.

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Manager, Downstream Manufacturing – TBF 100

  • College Station, Texas

Summary: The Downstream Manufacturing Manager – TBF 100 is responsible for assisting in the planning, directing, and coordinating of the activities related to the Downstream manufacturing processes for the start-up of the new Texas BioManufacturing Facility – 100 (TBF – 100) while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics. The Downstream Manufacturing Manager will oversee the cGMP production and Downstream manufacturing systems that support project SATURN, which is a multi-product manufacturing facility using a single-use bioreactor platform with multiple Upstreams feeding the Downstream. SATURN is a high throughput mAb (monoclonal antibody) facility that will create a world class platform to support our customers’ clinical and commercial products.

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Manufacturing – Compliance Coordinator

  • College Station, Texas

Summary: The Manufacturing Compliance Coordinator leads 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.

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Manufacturing – Manager, Technical Operations – Gene Therapy

  • College Station, Texas

Summary: The Manager of Technical Operations is an integral management position overseeing the Technical Operations department supporting Gene Therapy Manufacturing.
The Technical Operation Group, consisting of Manufacturing Readiness and Compliance Coordinators and Technical Operations Engineers, will provide Manufacturing technology, materials, readiness, and compliance expertise to the Manufacturing Organization to support:
• Customer Program Fit Assessments
• Technical Transfer from Process Development to Manufacturing
• Equipment SME support
• Manufacturing excellence
• Technical support for trouble shooting
• Technical training

It is expected that members of the Technical Operations group will have a strong background in Process/Equipment Engineering or GMP Biotechnology or Gene Therapy Manufacturing experience.

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Manufacturing – Readiness Coordinator

  • College Station, Texas

Summary: The Manufacturing Readiness Coordinator 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.

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Manufacturing Associate – Tech Lead

  • Hillerød, Denmark

Er du en dygtig linje-tekniker og operatør, har du erfaring med fejlfinding på teknisk udstyr, og vil du spille en vigtig rolle i en medicinalproduktion i verdensklasse hos Fujifilm Diosynth Biotechnologies? – og trives du med natarbejde?

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Manufacturing Process Engineer I

  • College Station, Texas

Summary: The Manufacturing Process Engineer I – TBF 100 is an entry-level position in the Manufacturing Technology Support (MT&S) department in support of the SATURN Project located at the Texas BioManufacturing Facility – 100 (TBF – 100) in College Station, Texas. This position will report directly to the Associate Director, MT&S, but may also jhave 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 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: Isolators and their use in cell propagation, Cell Culture/Single Use Technology, Dispensing and Mixing and Buffer Preparation. This position will also create training programs and perform training for manufacturing technicians in the unit operation categories.

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Manufacturing Process Engineer II

  • College Station, Texas

Summary: The Manufacturing Process Engineer – TBF 100 is a mid-level position in the Manufacturing Technology Support (MT&S) department in support of the SATURN mAb manufacturing facility located at the Texas BioManufacturing Facility – 100 (TBF – 100) in College Station, Texas. The SATURN Platform utilizes entirely single use technology and is a multi-stream, multi-product facility that will be manufacturing clinical and commercial products. As a CDMO, customer liaison is a vital part of our business and the Technical Operations team will act as the point of contact for our customers during manufacturing execution

The individual in this position will work independently and with colleagues to provide expertise and assistance for the design, development, standardization and maintenance of 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: Isolators and their use in cell propagation, Cell Culture/Single Use Technology, Filtration, Chromatography and Final Filtration. Core manufacturing technologies include Weigh and Dispensing and Mixing and Buffer Preparation.

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Manufacturing Supervisor – Upstream

  • College Station, Texas

Summary

The Manufacturing Supervisor – Upstream will work directly with cell-culture and viral propagation techniques; cell-culture and bioreactor operations; bacterial and fermentation operations; pDNA, protein, and yeast-related operations; and aseptic techniques while following cGMP procedures. This individual will also supervise a team of employees directly or indirectly in the Upstream process.

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Manufacturing Supervisor, Downstream – FBF 200

  • College Station, Texas

Summary: The Manufacturing Supervisor – Downstream will work directly with a range of purification technologies including continuous flow centrifugation, sucrose gradient separation, various filtration technologies (TFF & depth), chromatographic separations technologies (GE AKTA systems), and viral inactivation following aseptic technique in a cGMP environment. This individual will also supervise a team of employees directly or indirectly in the Downstream process.

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Marketing Specialist

  • College Station, Texas

Summary: As Marketing Specialist for FujiFilm Diosynth Biotechnologies Texas, LLC (FDBT) you will have responsibilities for the general day-to-day marketing activities required to support the Global Marketing Team and the FDBT Human Resources Team. This position will report directly to the VP, Global Marketing. This position will also work alongside the site’s Human Resources Department to manage, distribute and support coordination of internal site communications, support local HR events, assist with campaign development as well as analyze the effectiveness of each campaign. This position will be responsible for interfacing with local communities and openly representing our organization among pubic officials, businesses, other agencies, news outlets, and the public to increase awareness of FDB’s local activities.

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Materials Management Specialist I

  • College Station, Texas

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.

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Materials Management Specialist II

  • College Station, Texas

Summary: Under limited supervision of the Materials Manager, the Materials Specialist II is responsible for the accurate receipt, verification, record keeping, distribution, and shipment of materials and goods. Functional job responsibilities will include but are not limited to:

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Microbiology Analyst I

  • College Station, Texas

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.

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Microbiology Analyst II

  • College Station, Texas

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.

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Microbiology Analyst III

  • College Station, Texas

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.

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Process Maintenance Lead Technician

  • College Station, Texas

Summary: The Process Maintenance Lead Technician, under the supervision of the Process Maintenance Supervisor will be the individual primarily responsible for providing operational, maintenance, monitoring, and troubleshooting support for manufacturing process areas equipment in support of both the Texas Biological Facility (TBF) and the Flexible Biological Facility FBF (TLVF) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). The Process Maintenance Lead Technician will direct and coach other technicians and contractors ensuring safe, proper and efficient hands-on operation and maintenance, both routine and corrective of all process manufacturing equipment including but not limited to fermenters, bioreactors, tanks, chromatography columns, filtration skids, autoclaves, washers, centrifuges, mixers, agitators, and related support equipment such as pumps, fans, motors, valves, traps, etc. Maintenance activities would include troubleshooting, preventative and corrective interventions. This position will be required to use technical manuals, on-line resources and OEM representatives to maintain the equipment operational with a minimum of downtime. This position will be responsible for taking the lead in developing, changing and documenting maintenance procedures and training associates in the proper execution of these procedures. This position will work with other maintenance and technical trades, such as manufacturing operators, engineers, calibrations, validation and quality to help maintain these systems operational and in GMP condition. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory. The Process Maintenance Lead Technician will also be involved in the installation and connection of new process equipment on arrival and assist with any commissioning and qualification activity as required. This position will also work in support of the Environment, Health and Safety personnel (EHS) to ensure the systems are operated safely and within limits.

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Process Maintenance Lead Technician

  • College Station, Texas

Summary: The Process Maintenance Lead Technician, under the supervision of the Process Maintenance Supervisor will be the individual primarily responsible for providing operational, maintenance, monitoring, and troubleshooting support for manufacturing process areas equipment in support of both the Texas Biological Facility (TBF) and the Flexible Biological Facility FBF (TLVF) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). The Process Maintenance Lead Technician will direct and coach other technicians and contractors ensuring safe, proper and efficient hands-on operation and maintenance, both routine and corrective of all process manufacturing equipment including but not limited to fermenters, bioreactors, tanks, chromatography columns, filtration skids, autoclaves, washers, centrifuges, mixers, agitators, and related support equipment such as pumps, fans, motors, valves, traps, etc. Maintenance activities would include troubleshooting, preventative and corrective interventions. This position will be required to use technical manuals, on-line resources and OEM representatives to maintain the equipment operational with a minimum of downtime. This position will be responsible for taking the lead in developing, changing and documenting maintenance procedures and training associates in the proper execution of these procedures. This position will work with other maintenance and technical trades, such as manufacturing operators, engineers, calibrations, validation and quality to help maintain these systems operational and in GMP condition. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory. The Process Maintenance Lead Technician will also be involved in the installation and connection of new process equipment on arrival and assist with any commissioning and qualification activity as required. This position will also work in support of the Environment, Health and Safety personnel (EHS) to ensure the systems are operated safely and within limits.

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Process Maintenance Technician III

  • College Station, Texas

The Process Maintenance Technician, under the supervision of the Process Maintenance Supervisor will be the individual primarily responsible for providing operational, maintenance, and troubleshooting support for manufacturing process areas equipment in support of both the Texas Biological Facility (TBF) and the Flexible Biological Facility (FBF) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT).

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Process Sciences – Engineer I

  • College Station, Texas

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.

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Process Sciences – Engineer II

  • College Station, Texas

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.

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Process Sciences – Technician I

  • College Station, Texas

Summary: The Biotechnology Process Sciences Technician I functions within a team based organization to actively address cGMP manufacturing requirements. The individual’s main responsibility is to obtain documentation for cGMP appropriate materials (raw materials and components), prepare item specifications for these materials and track the completion of the specification paperwork. The individual will also assist with other cGMP pre-production activities such as the selection of cGMP appropriate materials and equipment as directed. 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.

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Program Coordinator I

  • College Station, Texas

Summary:
The Program Coordinator I, with direct supervision, will support site business planning and customer projects by maintaining relevant databases and liaising with Program Directors.

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Program Coordinator II

  • College Station, Texas

Summary:
The Program Coordinator II, with minimal supervision, will support site business planning and customer projects by maintaining relevant databases and liaising with Program Directors.

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Program Design Manager – Gene Therapy    

  • Billingham, United Kingdom

Program Design Manager – Gene Therapy    

Grade – 34

Salary – £39, 801 – 49, 750

Permanent 

Post Ref –  2020ATR116

Fujifilm Diosynth Biotechnologies based in Billingham, Stockton-on-Tees specialise in developing and manufacturing processes for customer’s biologic drugs and offering stability studies to support customer drug substance and drug products.

With plants in Billingham UK, Hillerod Denmark, North Carolina and Texas USA our Global Vision is to be the leading and most trusted global Contract Development and Manufacturing Organisation partner in the biopharmaceutical industry.

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Program Design Scientist / Program Design Manager

  • Billingham, United Kingdom

Program Design Scientist / Program Design Manager

Grade – 33 – 34

Salary – £35,385 – £49, 750

Permanent

Post Ref –  2020ATR117

Fujifilm Diosynth Biotechnologies based in Billingham, Stockton-on-Tees specialise in developing and manufacturing processes for customer’s biologic drugs and offering stability studies to support customer drug substance and drug products.

With plants in Billingham UK, Hillerod Denmark, North Carolina and Texas USA our Global Vision is to be the leading and most trusted global Contract Development and Manufacturing Organisation partner in the biopharmaceutical industry.

As we continue on a period of significant growth we have an opportunity for an individual to join the Program Design group.

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Program Manager

  • Research Triangle Park, North Carolina

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.

FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Program Manager to work at our RTP, NC location. The successful candidate will be accountable for the planning & delivery of programs from the point of contract signature (Scope of Work / Letter of Intent / Contract) through program closure. They will ensure we provide services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance). The Program Manager typically handles an average load of 2-4 programs receives and receives coaching & guidance from the Head of Program Management.

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Project Engineer – Capital Projects

  • College Station, Texas

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.

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Project Manager – Capital Projects

  • College Station, Texas

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.

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Project Manager, Global Business Change

  • College Station, Texas

JOB PURPOSE

Working as part of the Fujifilm Diosynth (FDB) Enterprise Project Management Office (ePMO), the job holder will project manage and/or play a significant role in the delivery of projects which are part of the FDB Global Business Change Plan (GBCP). This will involve key strategic and large matrix projects which include to varying degrees – global, multi-site, significant third party involvement and strategic client collaborations. The post holder will manage a portfolio of business projects, encompassing both development of systems and the delivery of business change (non-customer facing projects).

To be considered for this role qualified candidates MUST have 5 years of experience working within a Biotech/Pharma organization.

The GCBP is a rolling multi-year portfolio of projects that enable achievement of the agreed FDB Business Mid Term Plan (MTP)/Long Term Plan (LTP), required for long term business success. The delivery arm of the GCBP is the ePMO, which has been identified by the Executive Leadership Team (ELT) as a necessary foundation for the delivery of the high volume of transformation projects required in the FDB MTP/LTP.

The ideal candidate will possess excellent influencing skills and have demonstrable experience in realizing and driving forward a cohesive program of work, with the ability to resolve inter-dependencies across the company. The job holder is expected to have experience of successfully leading multi-stream or multi-site projects, delivering coherent, workable and ‘bought in to’ solutions. The successful candidate will be meticulous, process-driven and have first class organizational skills. Experience of relevant project management software applications is desirable.

** Relocation assistance is available for this position.

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QA Manager (Suppliers and Material Release)

  • Research Triangle Park, North Carolina

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.

We are seeking a highly motivated individual to join us as a QA Manager in our Contract Manufacturing site located in Research Triangle Park, NC. Primary responsibilities will be to lead the team responsible for supplier qualification and materials release.

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QA Technical Specialist (ARP)

  • Research Triangle Park, North Carolina

The Quality Assurance group at Fujifilm Diosynth Biotechnologies is seeking a highly motivated individual to join us as a QA Technical Specialist in our Contract Manufacturing site located in Research Triangle Park, NC. This is a second shift position. The ideal candidate will be a subject matter expert for Quality Assurance systems and compliance activities.

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QC Associate II

  • Research Triangle Park, North Carolina

The QC Associate II level analyst performs high throughput, right-first-time laboratory work to meet production schedules and project milestones. They are expected to follow procedures and have familiarity and proficiency with a wide variety of microbiological methods and supporting data management processes. Microbiological disciplines common to the laboratory include, but are not limited to: aseptic technique, bioburden testing (membrane filtration), endotoxin determination (kinetic chromogenic, gel clot), environmental and clean utility monitoring, Gram staining, and culture purity testing. The ideal candidate also has experience with automated and/or rapid microbiological methods.

This is a 2nd shift (1:30pm – Midnight) Wednesday – Saturday position. Due to the position hours, once adequately trained, the analyst may work with minimal direct supervision. The analyst may be responsible for prioritizing their individual workload, and will be relied upon to escalate concerns appropriately.

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QC Lead Associate I (Chromatography M-F 2nd Shift)

  • Research Triangle Park, North Carolina

The QC Lead Associate I will support a broad range of analytical disciplines within the Quality Control laboratory. This position will perform testing in the QC Analytical Chemistry laboratory. The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with minimal supervision. They are expected to follow procedures and have familiarity and proficiency with a wide variety of analytical methods and supporting data management processes. The individual effectively and efficiently manages complex or difficult tasks. Analytical disciplines common to the laboratory include, but are not limited to: Chromatography, HPLC, Concentration determination, pH, Total Organic Carbon, Gel based protein separation, IEF, Plate Based Assay, and conductivity. The position primarily works with or may take direction from peers within the department, but may work more independently according to the scheduled workload. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter experts.

This position will provide testing support in the chemistry laboratory across multiple chromatographic disciplines. This is a 2nd shift position (M – F).

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QC Lead Associate I (Chromatography Wed – Sat 2nd Shift)

  • Research Triangle Park, North Carolina

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 QC Lead Associate I will support a broad range of analytical disciplines within the Quality Control laboratory. This position will perform testing in the QC Analytical Chemistry laboratory. The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with minimal supervision. They are expected to follow procedures and have familiarity and proficiency with a wide variety of analytical methods and supporting data management processes. The individual effectively and efficiently manages complex or difficult tasks. Analytical disciplines common to the laboratory include, but are not limited to: Chromatography, HPLC, Concentration determination, pH, Total Organic Carbon, Gel based protein separation, IEF, Plate Based Assay, and conductivity. The position primarily works with or may take direction from peers within the department, but may work more independently according to the scheduled workload. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter experts.

This position will provide testing support in the chemistry laboratory across multiple chromatographic disciplines. This is a 2nd Shift Position, Wednesday – Saturday (2pm – Midnight).

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QC Lead Associate I (Chromatography)

  • Research Triangle Park, North Carolina

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 QC Lead Associate I will support a broad range of analytical disciplines within the Quality Control laboratory. This position will perform testing in the QC Analytical Chemistry laboratory. The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with minimal supervision. They are expected to follow procedures and have familiarity and proficiency with a wide variety of analytical methods and supporting data management processes. The individual effectively and efficiently manages complex or difficult tasks. Analytical disciplines common to the laboratory include, but are not limited to: Chromatography, HPLC, Concentration determination, pH, Total Organic Carbon, Gel based protein separation, IEF, Plate Based Assay, and conductivity. The position primarily works with or may take direction from peers within the department, but may work more independently according to the scheduled workload. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter experts.

This position will provide testing support in the chemistry laboratory across multiple chromatographic disciplines. This is a 1st shift position (M – F).

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QC Supervisor (2nd Shift)

  • Research Triangle Park, North Carolina

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.

We are seeking a highly motivated individual to join us as a QC Supervisor to work in our Contract Manufacturing site located in Research Triangle Park, NC. The RTP facility is a 7 day a week, 2-shift operation. This position will primarily be a Monday – Friday 1st shift position, but may require occasional weekend and/or holiday work. This role will be a hands-on leader reporting to a Quality Control Manager.

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Quality Assurance – Analyst I

  • College Station, Texas

Summary:
The Quality Assurance (QA) Analyst I, under direct supervision, will be responsible for assisting with the review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting with product related activities; Assisting with Quality audit functions; Identifying process and Quality System improvements;

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Quality Assurance – Analyst II

  • College Station, Texas

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.

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Quality Assurance – Analyst III

  • College Station, Texas

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.

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Quality Assurance – Manager, Operations

  • College Station, Texas

Summary: The Quality Assurance (QA) Manager of Operations, will be responsible for the overall performance of the QA Operations group. The Manager will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.

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Quality Assurance Lead Specialist, Training

  • College Station, Texas

Summary: The Quality Assurance (QA) Specialist, will be responsible for all aspects governing GxP training. The Specialist will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.

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Quality Assurance Manager, QA Validation

  • College Station, Texas

Summary: The Quality Assurance (QA) Manager, QA Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, and discrepancies. The Manager will handle all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.

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Quality Assurance Specialist, Compliance

  • College Station, Texas

Summary: The Quality Assurance (QA) Specialist of compliance, will be responsible for supporting performance of the Quality Systems group. The Specialist will assist with the tracking and coordination and closure of Deviations, Events, Change Controls, and CAPAs.

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Quality Assurance Specialist, Supplier Quality

  • College Station, Texas

Summary: The Quality Assurance (QA) Specialist Supplier quality will be responsible for supporting the supplier quality program. The Specialist will assist with ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.

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Quality Control – Cell Biology Analyst II

  • College Station, Texas

Summary: The Cell Biology Analyst II will be responsible for participating in the Technology Transfer of established methods into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.

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Quality Control – Cell Biology Analyst II

  • College Station, Texas

Summary The Cell Biology Analyst II will be responsible for participating in the Technology Transfer of established methods into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.

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Quality Control – Cell Biology Analyst III

  • College Station, Texas

Summary: The Quality Control Cell Biology III will be responsible for assisting in the qualification of test methods for in-process and final products. Be able to work under minimal supervision. Perform advanced assays requiring precise analytical skills and understanding of cell biology and immunology principles.

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Quality Control – Cell Biology Analyst III

  • College Station, Texas

Summary The Quality Control Cell Biology III will be responsible for assisting in the qualification of test methods for in-process and final products. Be able to work under minimal supervision. Perform advanced assays requiring precise analytical skills and understanding of cell biology and immunology principles.

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Quality Control – Chemist I

  • College Station, Texas

Summary The Quality Control Chemist I, under general direction, will be responsible for performing routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory.

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Quality Control – Chemist II

  • College Station, Texas

Summary: The Quality Control Chemist II, with limited supervision, will be responsible for participating in the Technology Transfer of established methods into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. Following Tech-Transfer Activities, the candidate will be responsible for performing release and stability testing using the established analytical methods.

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Quality Control – Chemist III

  • College Station, Texas

Summary: The Quality Control Chemist III, with limited supervision, will be responsible for participating in the Technology Transfer of established methods into the FUJIFILM Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. Following Tech-Transfer Activities, the candidate will be responsible for performing in-process, release and stability testing using the established analytical methods.

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Quality Control Cell Biology Analyst II

  • College Station, Texas

Summary The Cell Biology Analyst II will be responsible for participating in the Technology Transfer of established methods into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.

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Quality Control Cell Biology Lead

  • College Station, Texas

Summary: The Quality Control Cell Biology Lead, with limited supervision, will be responsible for overseeing day to day operations of the QC Cell Biology Group. This position will involve handing out daily assignments, ensuring assignments are completed within the given time period, and reviewing data. The Quality Control Cell Biology Lead will also participate in Project Team Meetings. The successful candidate will assist in Method Qualifications, Technology Transfer of established methods, and performing in-process, release and stability testing as needed.

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Quality Control Manager – Chemistry

  • College Station, Texas

Summary The Quality Control Chemistry Manager, under general supervision, will be responsible for planning, organizing, directing, and evaluating routine activities of the QC staff as well as overseeing all raw material testing and release for use in GMP production. The Chemistry Manager will lead tech transfer activities of qualified analytical methods from designated donor laboratories. The Chemistry Manager will play a pivotal role in selecting qualified personnel to staff the QC chemistry laboratory.

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Regulatory Affairs Manager

  • Research Triangle Park, North Carolina

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 Senior QA Manager is responsible for providing regulatory expertise to the site and, as directed, to other FDB sites.  Performs regulatory surveillance, interpreting regulatory documents into site-specific and into multi-site documentation, ensures site master files are maintained and published, and collaborates with Clients on regulatory responses and commitments pre- and post-PAI.   The individual is a subject matter expert with regard to QA and regulatory practices and procedures and provides leadership to others while providing regulatory direction throughout the organization. This position reports to Associate Director, QA and will have additional matrix reporting responsibilities and accountabilities.

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Scientist I (Science Innovation)

  • College Station, Texas

Summary:

The Scientist I, under general supervision, will help FDBT perform innovation in support of Advanced Therapies by preparing AAV materials (full and empty particles), improve or develop analytical methods, evaluate cell lines and plasmid reagents, and collaborate with scientific partners to evaluate new upstream and downstream methodologies.

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Scientist II – Downstream Process Development

  • College Station, Texas

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.

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Scientist II, Analytical Development

  • Research Triangle Park, North Carolina

The Fujifilm Diosynth Biotechnologies, USA Analytical Development group is seeking a skilled scientist to fill an exciting technical leadership role as Senior Scientist located at the Bioprocess Innovation Center in Morrisville, North Carolina.

The Scientist II independently designs, executes and interprets complex laboratory experiments and development activities with priorities set by supervisor to achieve project goals. The individual demonstrates a practical understanding of own scientific discipline and applies knowledge in support of product development and new technologies.

The successful candidate will act as the technical subject matter expert. The individual will have demonstrated expertise in the development and application of analytical methods for release and characterization of recombinant biopharmaceutical products. The candidate will have demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought. This position will contribute to the success of projects in various stages of cross-functional development and tech transfer by designing and planning all analytical aspects of the project, monitoring timeline adherence, reviewing scientific data, writing protocols and reports, representing the analytical development group in client interactions and managing project deliverables internally and externally.

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Senior Commercial Process Engineer

  • Research Triangle Park, North Carolina

At Fujifilm Diosynth Biotechnologies, we are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live.  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 and partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients.

We are seeking a candidate for a Senior Commercial Process Engineer (CPE) Position, within the Commercial Operations organization.  The successful candidate must have a proven ability to work independently and collaboratively to achieve optimized strategies, and execute programs with the ultimate goal of delivering products that transform the lives of patients. The CPE will provide oversight for the technical execution, standardization and monitoring of commercial product(s), as well as drive continuous improvement around production, compliance and safety. The CPE will be the technical subject matter expert for core manufacturing and operational technologies: Fermentation, Cell Culture, Filtration, Centrifugation, Chromatography and Single Use Technologies.

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Senior Director of Human Resources

  • Research Triangle Park, North Carolina

The Senior Director of Human Resources is responsible for planning, developing, implementing and directing policies and programs encompassing all aspects of human resources, including strategic planning, organizational design, employment, compensation and benefits, employee relations, equal employment opportunity, performance management, employment law, compliance and human resource information systems management. They are responsible for driving and supporting a positive culture by sponsoring teams that focus on employee engagement programs, efforts and activities for the site. Responsible for the oversight of the FDBU Training Department. Responsible to the COO for the effective and efficient utilization of manpower for the Company.

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Senior Financial Analyst

  • College Station, Texas

Summary: The Senior Financial Analyst is responsible for fiscal functions of the Company in accordance with generally accepted accounting principles and in accordance with financial management techniques and practices appropriate within the contract manufacturing industry.

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Senior LIMS Implementation Manager

  • Research Triangle Park, North Carolina

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.

We are seeking a highly motivated individual for a Senior QA Manager (LIMS) position. The successful candidate will be responsible for developing the strategic plans for the implementation of FDB’s global LIMS (laboratory information management system). This individual will be responsible for harmonizing process across all FBD sites, present and future. In addition will be responsible to drive QC to a paperless environment. Will direct a team of LIMS experts to interpret global and site-specific needs into user and system design and configuration requirements and into the implementation plan. The individual will be the primary LIMS subject matter expert (SME) and will maintain and continuously improve the global LIMS system

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Senior Manufacturing Lead – Downstream

  • College Station, Texas

The Senior Manufacturing Lead – Downstream will lead a team and work directly with a range of purification technologies including: filtration technologies (TFF and depth), chromatographic separations (Single Use GE AKTA systems), viral inactivation, etc. following aseptic techniques and procedures in a cGMP environment.

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Senior Manufacturing Lead – Upstream

  • College Station, Texas

The Senior Manufacturing Lead – Upstream will lead a team and work directly with a range of technologies following aseptic techniques and procedures in a cGMP environment.

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Senior Quality Assurance Manager, Compliance

  • College Station, Texas

Summary: The Senior Quality Assurance (QA) Manager, Compliance will be responsible for the overall performance of the Quality Systems group. The Manager will handle all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.

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Senior Scientist – Analytical Method Transfer

  • College Station, Texas

Summary: The Senior Scientist – Analytical Method Transfer (AMT) will function collaboratively and productively in a team devoted to ensuring the quality of effective analytical methods at FDBT. The individual should possess broad scientific knowledge of bioanalytical techniques that are used to assess viruses and proteins as well as strong technical writing skills.

The AMT group is a protocol-driven group which will primarily perform Tech Transfer, Qualification, and Validation of test methods coming out of the FDB analytical groups and transition them into our Quality Control group. The position will predominately focus on creating analytical method protocols and summary reports, executing protocols, reviewing data, ensuring a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success, troubleshooting issues/spearheading investigations and working closely with the QA group and client. The candidate will be expected to follow cGMP documentation practices.

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Senior Scientist, Analytical Development

  • Research Triangle Park, North Carolina

The Fujifilm Diosynth Biotechnologies, USA Analytical Development group is seeking a skilled scientist to fill an exciting technical leadership role as Senior Scientist located at the Bioprocess Innovation Center in Morrisville, North Carolina.

The successful candidate will lead matrix team execution of client-based projects within the Analytical Development group. The individual will have demonstrated expertise in the development and application of analytical methods for release and characterization of recombinant biopharmaceutical products. The candidate will have demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought. This position will contribute to the success of projects in various stages of cross-functional development and tech transfer by designing and planning all analytical aspects of the project, monitoring timeline adherence, reviewing scientific data, writing protocols and reports, representing the analytical development group in client interactions and managing project deliverables internally and externally.

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Senior Scientist, Process Development Upstream

  • College Station, Texas

Summary: The Senior Scientist Upstream will provide technology leadership for the Upstream Process Development and Manufacturing Teams to achieve Phase I & II production in a cGMP facility 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.

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Senior Scientist, Process Development Upstream

  • College Station, Texas

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.

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Senior Validation Engineer

  • College Station, Texas

Summary: The Sr. Validation Engineer, under general direction, will be responsible for drafting and executing Installation, Operational, and Performance qualification protocols for facilities, utilities, manufacturing equipment, quality control equipment, cleaning processes, and manufacturing processes across multiple GMP facilities as well as preparing validation summary reports for the same.

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Sr. Automation Engineer (Saturn)

  • College Station, Texas

Summary: The Senior Automation Engineer provides technical support and accountability for the execution of capital projects that are critical to the success of our business. The Senior Automation Engineer will participate in the development, installation, operation, maintenance, and repair of all FUJIFILM Diosynth Biotechnologies Texas automation systems to meet organizational goals and objectives. This position will also work closely with other operators, calibration technicians and engineers to maintain complex systems.

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Sr. Principal Scientist Group Leader, Upstream Process Development

  • College Station, Texas

Summary: The Sr. Principal Scientist Group Leader, Upstream Process Development, functions independently and productively in the Upstream Process Development Group actively engaged in process development within a team-based PD laboratory to support a wide variety of vaccine development projects. The Sr. Principal Scientist Group Leader is responsible for managing a group of scientists and providing technical or scientific leadership with the research and development organization including ongoing coaching and feedback, performance management, and ensuring the goals of the group are met.

The individual should display strong technical knowledge and scientific understanding of cell and virus cultures, expansion, harvest, medium development, clone selection and development, and DOE studies, as well as having experience in process development with both small and large process scales for vaccine development. The individual will lead multiple projects and is expected to provide significant scientific and technical contributions within the Process Development Group and will work closely with other Departments to develop strong working relationships.

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System Manager

  • Hillerød, Denmark

We are looking for System Managers to join our Information Technology Department. You will be responsible for operation and maintenance of the defined GxP and non-GxP IT systems across departments as well as instruments systems.

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Upstream Manufacturing Technician I

  • College Station, Texas

Summary: The Upstream Manufacturing Technician I 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.

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Upstream Manufacturing Technician II

  • College Station, Texas

Summary: The Upstream Manufacturing Technician II will work directly with a range of technologies following aseptic techniques and procedures in a cGMP environment.

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Upstream Manufacturing Technician III

  • College Station, Texas

Summary: The Upstream Manufacturing Technician III will work directly with a range of technologies following aseptic techniques and procedures in a cGMP environment.

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Utilities Maintenance Technician I

  • College Station, Texas

Summary: The Utilities Maintenance Technician I, under the supervision of the Facilities Maintenance Supervisor, or designated supervisor will be responsible for performing various aspects of utilities maintenance and support for facility including the Texas Biological Facility (TBF), the Flexible Biological Facility (FBF) and the National Center for Therapeutic Manufacturing (NCTM) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT).
Primary responsibilities include operation and monitoring of utilities equipment including but not limited to electrical switchgear, chillers, chilled water distribution systems, air handling units and fan coil units, heat recovery systems, heating water and steam boilers, air compressors and dryers, RO water purification skids, ultrapure water distillation units, clean steam generators, waste water treatment systems, freezers, refrigerators, walk-in cold rooms, temperature control systems, and related support equipment such as pumps, fans, motors, variable frequency drives, valves, traps, etc. Light maintenance tasks will be required on the listed utility systems.
This position will be required to use technical manuals, on-line resources and OEM representatives to maintain the equipment operational with a minimum of downtime. This position will work with other maintenance and technical trades, such as contractors, engineers, metrology, validation and quality to help maintain these systems operational and in GMP condition. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory.
The Utilities Maintenance Technician I will also be available to work with higher skilled maintenance staff to support maintenance activities on other systems and equipment as needed such as, fermenters, bioreactors, tanks, chromatography columns, filtration skids, centrifuges, autoclaves, washers, agitators, etc. in coordination with other maintenance technicians and manufacturing operators. In addition, will also be involved in the installation and connection of new process equipment on arrival and assist with any commissioning and qualification activity as required. This position will also work in support of the Environment, Health and Safety personnel (EHS) to ensure the systems are operated safely and within limits.

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Utilities Maintenance Technician II

  • College Station, Texas

Summary: The Utilities Maintenance Technician II, under the supervision of the Process Maintenance Supervisor will be primarily responsible for installing, maintaining and repair of electrical components and systems as well as providing operational, maintenance, and troubleshooting support for utilities equipment in support of multiple facilities including the Texas Biological Facility (TBF), the Flexible Biological Facility (FBF) and the National Center for Therapeutic Manufacturing (NCTM) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT).
Primary responsibilities include ensuring safe and efficient hands-on maintenance of all utilities equipment including but not limited to electrical switchgear, switchboards, distribution panels, control panels standby electrical generators, chillers, chilled water distribution systems, air handling units and fan coil units, heat recovery systems, heating water and steam boilers, air compressors and dryers, RO water purification skids, ultrapure water distillation units, clean steam generators, waste water treatment systems, freezers, refrigerators, walk-in cold rooms, temperature control systems, and related support equipment such as pumps, fans, motors, variable frequency drives, valves, traps, etc.
Maintenance activities would include troubleshooting, preventative and corrective interventions.
This position will be required to use technical manuals, on-line resources and OEM representatives to maintain the equipment operational with a minimum of downtime. This position will work with other maintenance and technical trades, contractors, engineers, metrology, validation and quality to help maintain these systems operational and in GMP condition. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory.
The Utilities Maintenance Technician II will also be available to support maintenance activities on other process systems and equipment as needed such as, fermenters, bioreactors, tanks, chromatography columns, filtration skids, centrifuges, autoclaves, washers, agitators, etc. in coordination with other maintenance technicians and manufacturing operators. In addition, will also be involved in the installation and connection of new process equipment on arrival and assist with any commissioning and qualification activity as required. This position will also work in support of the Environment, Health and Safety personnel (EHS) to ensure the systems are operated safely and within limits.

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Validation Engineer

  • Hillerød, Denmark

We are looking for Validation Engineers to join our Information Technology Department. You will be part of setting the overall Computerised System Validation (CSV) strategy and set the direction on CSV for specific projects and implementations.

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Validation Engineer I

  • College Station, Texas

The Validation Engineer I, under general direction, will be responsible for drafting and executing validation protocols for facilities, utilities, manufacturing equipment and quality control equipment, as well as preparing validation final reports for the same.

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Validation Manager

  • College Station, Texas

Summary: The Validation Manager will be responsible for drafting and executing cleaning, process validation, utility, process systems and process support systems qualification test work. Preparing validation summary reports for the qualification and validation of systems used to manufacture drug or biologics products.

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Validation Specialist I

  • College Station, Texas

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

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Validation Specialist II

  • College Station, Texas

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.

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Vice President of Process Development

  • Research Triangle Park, North Carolina

The Vice President of PD provides strong leadership to the major process development departments, fostering an environment where innovation and efficiency can both thrive, setting annual goals and objectives and long range planning. The VP, PD creates high-level business strategy for the, oversees the management of resources and coordinates activities across multiple departments to achieve business objective and revenue goals. They will serve as the strategic leader for the site and advocates for the process development and Innovation departments with upper management and external parties.

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Virology Technician II

  • College Station, Texas

Summary:

The Virology Technician II, under direct supervision, will assist in the culture and growth of cells and BSL-2 viruses for the support of V-AD and PD activities for multiple client projects. This individual will support assay development by performing tests on incoming, in-process, and finished product including release testing and testing of critical reagents. This individual will also be involved in the transfer and development of analytical assays to support product release, in-process sample testing and characterization, as well as the growth and maintenance of analytical cell lines.

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