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:

 

 

 


Filter by location: Filter by department:

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.

Read More

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.

Read More

Asset Maintenance Group Manager

  • Billingham, United Kingdom

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

With plants in Billingham and Wilton 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 to increase output from the Billingham site, an opportunity has arisen for an Asset Maintenance Group Manager to join our team.  The post holder will supervise and direct the maintenance technicians who support our GMP manufacturing assets.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

Associate Program Director

  • College Station, Texas

Summary: The Associate Program Director, 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.

Read More

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.

Read More

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.)

Read More

Associate Scientist/Scientist I, Analytical Development

  • 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 Analytical Development group is seeking an energetic Associate Scientist or Scientist I with protein chemistry experience to become an integral member of a high performing method transfer team supporting protocol based activities including technical transfer of methods from donor labs as well as training of colleagues for internal transfer, and qualification, validation and verification of methods. The successful candidate will primarily execute biochemistry based techniques such as UPLC/HPLC (SEC, IEX, RP, glycan, affinity, etc.), capillary electrophoresis (icIEF, CE-SDS), gel electrophoresis, UV, western blot (SDS-Page), plate based assays and spectrophotometry (SoloVPE) for the characterization and testing of recombinant protein pharmaceuticals.

Read More

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.

Read More

Business Analyst

  • Hillerød, Denmark

Would you like an exciting job with plenty of opportunity to grow? We are looking for a Business Analyst who will be the link between our Digital Technologies department and our business objectives. You will be close to the heart of the business and get a good understanding of the pharma industry.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

Compliance Associate (Supply Chain)

  • Hillerød, Denmark

We are looking for a new colleague in the Supply Chain organisation to provide support in all compliance and GMP related matters. 

Read More

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).

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

Electrical Engineer

  • Hillerød, Denmark

For the Plant Engineering team in Hillerød we are looking for an experienced Electrical Engineer who will act as the Subject Matter Expert on Electrical Systems, troubleshoot complex equipment failure and perform root cause analysis.

Read More

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.

Read More

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.

Read More

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.

Read More

Graduate Process Engineers

  • Billingham, United Kingdom

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

With plants in Billingham and Wilton UK, 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 a number of Graduate Process Engineers to join the Company.

Read More

Head of Engineering

  • 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.

As we invest in expanding our manufacturing facilities, a vacancy has arisen for a Head of Engineering to join the company.

Read More

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.

Read More

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.

Read More

Lead QC Associate II (Micro)

  • Research Triangle Park, North Carolina

The QC Lead Associate II is a senior analyst position and is responsible for both sample analysis as well as coordination of laboratory processes in the QC Microbiology 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 microbiological methods and supporting data management processes. Microbiological disciplines common to the laboratory include, but are not limited to: aseptic technique, bioburden testing, endotoxin determination (kinetic chromogenic, gel clot), environmental and clean utility monitoring, Gram staining, and culture purity testing. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matters experts. The ideal candidate also has experience with automated and/or rapid microbiological methods.

In addition to supporting sample testing, this position is also responsible for developing, maintaining and improving laboratory processes. This may include, but is not limited to, working with internal functions to ensure material and equipment readiness, interfacing with vendors, and implementing continuous improvement projects in the QC Microbiology laboratory.
The ideal candidate will supplement these roles with experience in one or more of the following topics, thereby expanding the subject matter expertise of the QC Department:

• Automated bioburden or endotoxin technology
• Microbial identification and assessment
• Trending of environmental monitoring data

This position will provide testing and coordination support in the microbiology laboratory. This is a 1st shift, Monday – Friday position.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

Manufacturing Associates for Drug Substance Manufacturing

  • Hillerød, Denmark

For the Drug Substance Manufacturing Unit in Hillerød, Fujifilm Diosynth Biotechnologies is looking for Manufacturing Associates to support biopharmaceutical production operations.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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:

Read More

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.

Read More

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.

Read More

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.

Read More

Plant Engineer

  • Hillerød, Denmark

We are looking for a new colleague to join our Plant Engineering team. Do you have experience with Plant Utility systems and would you like to provide engineering technical support for Plant Utilities and Support Equipment at our Manufacturing Facility in Hillerød?

Read More

Principal Scientist – Downstream Group

  • Wilton, 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 opportunity for a Principal Scientist (Maternity cover) for 12 months in the Wilton Downstream Group in our Research & Development department within FUJIFILM Diosynth Biotechnologies, Wilton, UK in a brand new, state of the art facility.

Read More

Principal Scientist – Upstream Mammalian

  • 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.

As we continue on a period of significant growth we have an opportunity for a Principal Scientist to join the Company.

Read More

Principal Scientists x 3

  • Billingham, United Kingdom

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

With plants in Billingham and Wilton 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 a period of significant growth, we are currently recruiting a number of scientists in Analytical Development and Upstream and Downstream Operations in our Process Development department within Fujifilm Diosynth Biotechnologies, UK.

Read More

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.

Read More

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.

Read More

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).

Read More

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.

Read More

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.

Read More

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.

Read More

Production Technologists

  • 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 and Wilton 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 immediate opportunities for Production Technologists within the Microbial Manufacturing team.

Read More

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.

Read More

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.

Read More

Program Director

  • College Station, Texas

Summary: The 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 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).

Read More

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.

Read More

Programme Manager

  • 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 and Wilton 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 a Programme Manager to join the Company.

Read More

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.

Read More

Project Engineer I

  • 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 searching for a Project Engineer I, entry level position in the Engineering department of FDBU. This position will directly report to the Engineering Director, but may also have a functional reporting relationship to a senior colleague on a project to project basis. The Project Engineer I oversees the day-to-day project management activities of small to medium sized projects ($10K – $1M) for new processing or facility equipment, modifications to existing systems aimed at cost reduction, safety/quality/efficiency improvements, sustainability, and budgetary proposals for new business.

Read More

Project Engineering Manager

  • 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.

An exciting opportunity has arisen for a Project Engineering Manager to become an integral part of our continued expansion. The role is responsible for managing a team of project engineers to deliver technically assured engineering projects in the highly regulated GMP environment.

Read More

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.

Read More

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).

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.

Read More

Project Manager, Global Business Change

  • 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 searching for a Project Manager, Global Business Change. 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.

Read More

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.

Read More

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.

Read More

QA/QE Specialist for Finished Goods Manufacturing and Drug Substance MFG

  • Hillerød, Denmark

Are you a self-driven and motivated team-player with a “go-do” attitude, and are you a person who takes ownership and responsibility of your assignments? Then you might be our new colleague!

Read More

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.

Read More

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;

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

Research/Senior Scientists x 7

  • Billingham, United Kingdom

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

With plants in Billingham and Wilton 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 a period of significant growth, we are currently recruiting a number of scientists in Analytical Development and Upstream and Downstream Operations in our Process Development department within Fujifilm Diosynth Biotechnologies, UK.

Read More

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.

Read More

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.

Read More

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 Scientist II 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.

Read More

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.

Read More

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

Read More

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.

Read More

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.

Read More

Senior Production Technologist (MCC, NPI)

  • Billingham, United Kingdom

Fujifilm Diosynth Biotechnologies based in Billingham, Stockton-on-Tees specialise in developing manufacturing processes for customers 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 a Senior Production Technologist within the MCC Manufacturing NPI team.

Read More

Senior QA Technical Specialist (QA Systems and Compliance)

  • 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 function as a Quality Assurance SME, with limited supervision, in our Contract Manufacturing site located in Research Triangle Park, NC. Primary responsibilities will be to support the QA Systems team responsible for monitoring Deviations, CAPAs, and Change Controls/management, performance of external audits/site inspections and readiness activities. Successful candidate will have a proven track record of leading teams and collaborating cross-functionally. Experience with change management review boards is a plus.

Read More

Senior QA Technical Specialist, Supplier Management 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 Senior QA Technical Specialist in our Contract Manufacturing site located in Research Triangle Park, NC. The position acts as the subject matter expert (SME) for multiple or complex Quality Assurance supplier management and material release activities under limited supervision. Successful candidate will have a proven track record of managing projects and cross-functional collaboration.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

Senior Staff Scientist (Process Design)

  • 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 and Wilton 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 temporary Senior Staff Scientist to join the Process Desgin Department. Reporting to the Director of Late Phase CMC –The position will be a key member of the Process Design team.

Read More

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.

Read More

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.

Read More

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.

Read More

UK Student Industrial Placements – 2020/21

  • Billingham, United Kingdom

FUJIFILM Diosynth Biotechnologies is a biopharmaceutical company within FUJIFILM corporation with development and manufacturing sites in Billingham, UK, Research Triangle Park, North Carolina and College Station, Texas, USA employing over 1000 staff. Globally we have over 35 years of clinical and commercial experience in biopharmaceutical development and cGMP manufacturing. We are one of the world’s leading GMP drug Contract Manufacturing Organisations (CMO) through the continuous innovation of technologies, service delivery and quality – contributing to the enhancement of the quality of life of people worldwide.

Every year in the UK, we recruit undergraduate degree students on sandwich degree courses for a 12 month work experience placement. The scheme provides paid placements in our Process Development department within FUJIFILM Diosynth Biotechnologies, Billingham, UK.

This is a fantastic opportunity to gain an insight into the operation of an international biopharmaceutical CMO. Working alongside experienced scientists you will advance your own academic knowledge and technical skills.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More