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 and Billingham, United Kingdom.

Grow Your Career

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

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

 

Learn more about our CURRENT opportunities around the globe:

 

 

 


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Analytical Development – Scientist I

  • College Station, Texas

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

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Analytical Development – Technician I

  • College Station, Texas

Summary:

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

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Apprentice – Instrument Technician

  • United Kingdom, Billingham

Fujifilm Diosynth Biotechnologies is one of the world’s leading contract manufacturers of biopharmaceuticals, with development and manufacturing sites in Billingham, UK and in North Carolina and Texas, USA. Employing over 1000 staff globally, Fujifilm has over 30 years of clinical and commercial experience in biopharmaceutical development and cGMP manufacturing.

Our customers, who are international pharmaceutical and biotechnology companies, invent drugs to help cure diseases which currently may have no effective treatment. Our role is to develop and operate processes to manufacture these drugs efficiently and cost-effectively, thereby potentially saving or enhancing the lives of thousands of people worldwide.

The development of biopharmaceuticals and viral products is at the forefront of innovation in science today, and it provides a world of exciting opportunity. At Fujifilm Diosynth we work in partnership with our customers, helping them to bring their biologics and vaccines products from the initial laboratory stages right through to the patient whose life they’ll be changing for good. So, if you are looking for an inspiring career at the cutting edge of science then there are opportunities for you.

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Apprentice – Mechanical Technician

  • United Kingdom, Billingham

Fujifilm Diosynth Biotechnologies is one of the world’s leading contract manufacturers of biopharmaceuticals, with development and manufacturing sites in Billingham, UK and in North Carolina and Texas, USA. Employing over 1000 staff globally, Fujifilm has over 30 years of clinical and commercial experience in biopharmaceutical development and cGMP manufacturing.

Our customers, who are international pharmaceutical and biotechnology companies, invent drugs to help cure diseases which currently may have no effective treatment. Our role is to develop and operate processes to manufacture these drugs efficiently and cost-effectively, thereby potentially saving or enhancing the lives of thousands of people worldwide.

The development of biopharmaceuticals and viral products is at the forefront of innovation in science today, and it provides a world of exciting opportunity. At Fujifilm Diosynth we work in partnership with our customers, helping them to bring their biologics and vaccines products from the initial laboratory stages right through to the patient whose life they’ll be changing for good. So, if you are looking for an inspiring career at the cutting edge of science then there are opportunities for you.

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Apprentices – Site Services Technicians (x2)

  • United Kingdom, Billingham

Fujifilm Diosynth Biotechnologies is one of the world’s leading contract manufacturers of biopharmaceuticals, with development and manufacturing sites in Billingham, UK and in North Carolina and Texas, USA. Employing over 1000 staff globally, Fujifilm has over 30 years of clinical and commercial experience in biopharmaceutical development and cGMP manufacturing.

Our customers, who are international pharmaceutical and biotechnology companies, invent drugs to help cure diseases which currently may have no effective treatment. Our role is to develop and operate processes to manufacture these drugs efficiently and cost-effectively, thereby potentially saving or enhancing the lives of thousands of people worldwide.

The development of biopharmaceuticals and viral products is at the forefront of innovation in science today, and it provides a world of exciting opportunity. At Fujifilm Diosynth we work in partnership with our customers, helping them to bring their biologics and vaccines products from the initial laboratory stages right through to the patient whose life they’ll be changing for good. So, if you are looking for an inspiring career at the cutting edge of science then there are opportunities for you.

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Associate Director, Downstream Process Development

  • College Station, Texas

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

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

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Associate 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 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 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 Project Director typically manages programs of shorter duration and/or fewer concurrent programs relative to a Project Director.

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Associate Scientist – Downstream Process Development

  • College Station, Texas

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

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Business Development Specialist (West Coast/Texas)

  • College Station, Texas

Fujifilm Diosynth Biotechnologies, U.S.A., Inc. is seeking a Business Development Specialist (internally known as Commercial Development Specialist) to support our West Coast/Texas business. The successful candidate will Identify and manage the initial sales lead qualification and support the Directors of Commercial Development in acquiring new business with new customers.

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Calibration Technician II

  • College Station, Texas

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

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Calibration Technician III

  • College Station, Texas

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

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Central Service Coordinator I

  • College Station, Texas

Summary: The primary job responsibilities of this position will be scheduling the cleaning regiments for our three different locations, as well as reviewing the log books for all three sites.

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Director, Capital Project Management

  • College Station, Texas

Summary:

FUJIFILM Diosynth Biotechnologies Texas, LLC. (FDBT) is seeking a Program Director (Capital Projects). The successful candidate is recognized as a senior level project manager with an extensive background in capital project management. The position will ensure deliverables for his/her respective projects are well managed and in line with their stakeholders expectations.

Reporting directly to the Head of Program Management, the Program Director (Capital Projects) oversees the day-to-day project management activities of capital projects ranging from simple scope equipment procurement ($10K – $1M) to more complex scope involving facility construction/modification ($1M – $10M) aimed at cost reduction, efficiency improvements, system sustainability, and quality/safety enhancement.

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Director, Program Design for Advanced Therapy Programs

  • 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 Program Design Director will be the technical lead for potential projects from customers; leading technical discussions and presenting Fujifilm Diosynth’s experience, expertise and leadership in viral-derived advanced therapy production, including but not limited to gene therapy and viral vectors. They will proactively engage with both commercial and process development teams at all locations (with Texas focused) to scope and draft compelling and innovative proposals to support the commercial team in winning new business with a focus on advance therapy opportunities.

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Director, QC

  • Research Triangle Park, North Carolina

The Director / Senior Director of QC is responsible for directing Fujiflm Diosynth Biotechnologies U.S.A., Inc. (FDBU) Quality Control (QC) Laboratory operations at the Morrisville North Carolina site. The QC laboratories, equipment, operations, methods, and procedures are expected to be maintained in compliance with applicable cGMP regulations. The FDBU QC Laboratory provides analytical and microbiological testing of: raw materials; both clinical and commercial Active Pharmaceutical Ingredients (API) and Drug Products (DP) for in-process, release and stability programs; cleaning and Environmental Monitoring. This position is expected to provide strong leadership within their department, as a key cross-functional partner within the site, and a partner with our customers regarding QC operations. They are responsible for assuring compliance in the Quality Control laboratory operation, managing and developing people, managing to budget, achieving revenue and profit goals.

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Director, Quality Assurance Compliance

  • College Station, Texas

Summary: The Director, QA Compliance will be responsible for oversight of QA Compliance for cGMP manufacturing of monoclonal antibodies and Gene Therapy/Viral products.
The individual will work with global and site Quality to implement, maintain and improve Quality Management Systems and programs to maintain FDBT facilities inspection ready.

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Director, Upstream Process Development

  • College Station, Texas

Summary: The Director, 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 individual should display strong technical knowledge and scientific understanding of cell and virus culture, 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 provide significant scientific and technical contributions within the Process Development Group and will work closely with the customer to develop strong working relationships.

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Downstream Manufacturing Technician I

  • College Station, Texas

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

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Downstream Manufacturing Technician II

  • College Station, Texas

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

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Downstream Manufacturing Technician III

  • College Station, Texas

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

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Downstream Process Development Intern (Purification)

  • College Station, Texas

Summary: The Downstream Process Development Intern (Purification) will provide support in the PD department by assisting in development of a downstream plasmid DNA purification process. The intern will establish and assist in automating the process for efficiency. The internship typically will last up to 3 months and the time frame/schedule for the position will be determined by the Director, HR and Intern.

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Downstream Production Technician

  • Research Triangle Park, North Carolina

Fujifilm Diosynth Biotechnologies, U.S.A., Inc. is seeking a Downstream Production Technician to work in our Downstream Manufacturing group. The successful candidate will execute Development and Production processes as well as the accompanying documentation. We have day and night shift rotating shifts available (7:00 am – 7:00 pm and 7:00 pm – 7:00 am).

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Drug Product Operations – Technician IV

  • College Station, Texas

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

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EHS Specialist I

  • College Station, Texas

Summary: The EHS Specialist, under the supervision of the Sr. Manager, Biosafety & EHS, will be responsible for development and application of various safety and compliance programs at Fujifilm Diosynth Biotechnologies Texas (FDBT). Programs include occupational health and safety, fire safety, emergency response, management of hazardous and other special wastes, industrial hygiene, respiratory protection and environmental programs within the scope of EHS.

This position is expected to be aware of all applicable OSHA and environmental regulations as they apply to FDBT and help maintain compliance with local, state and federal regulations for occupational and environmental safety. The EHS Specialist will be familiar with the processes involved in pharmaceutical manufacturing and provide EHS support, as applicable

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EHS Technician Apprenticeship

  • United Kingdom, Billingham

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

As we continue on a period of significant growth we have an opportunity for an Apprentice Environmental, Health and Safety technician to join the Company.

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EM Technician I – Temporary

  • College Station, Texas

Summary The Temporary Environmental Monitoring Technician, under general direction, will be assisting with routine and non-routine environmental monitoring and other duties within the Quality Control (QC) Laboratory. This position has the primary responsibility of assisting with environmental monitoring. Other responsibilities may include but are not limited to: Daily reporting of instrument calibration, and other general lab and lab related administrative responsibilities, as needed. This position may last up to, but will not exceed 12 months

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Equipment Engineer III

  • College Station, Texas

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

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

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

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Facility Maintenance Technician

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

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

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

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Head of Operational Excellence

  • College Station, Texas

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

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Head of Process Development

  • College Station, Texas

Summary: The Head of Process Development provides strong scientific and administrative leadership to the Process Development and Process Sciences Departments, setting annual goals and objectives and long range planning. The Department Head creates high-level business strategy for the departments, oversees the management of resources and coordinates activities across multiple departments to achieve business objectives and revenue goals. This individual serves as the strategic leader and an advocate for the departments’ issues with upper management and external parties.
The Head of Process Development will lead Downstream, Upstream, Virology/Analytical Development and Process Sciences groups.
The individual will provide significant scientific and technical contributions and will work closely with the customer to develop strong working relationships. This position supports the process development / process sciences and manufacturing organizations with their associated revenue and profit plans as they relate to the on-time delivery of analytical and process development milestones. This individual has direct impact on overall company performance; impact is achieved primarily by directing the department.

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Human Resources Specialist (Temporary)

  • College Station, Texas

Summary: As part of the Human Resources team, the (Temporary) Human Resources Specialist will be responsible for supporting the staffing efforts of Fujifilm Diosynth Biotechnologies Texas, LLC (FDBT) and building a strong workforce that adds to the company’s bottom line. This highly skilled HR professional should possess knowledge of employment and labor law, have a deep understanding of the organization and its staffing needs, and possess strong interpersonal and communication skills. The HR Specialist will be expected to find potential candidates, screen them, and recommend them for placement. The process of recruiting may involve both internal and external sourcing methods, thereby requiring the HR Specialist to be adept at understanding where and how to locate candidates.

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Human Resources Talent Acquisition Specialist

  • College Station, Texas

Summary: As part of the Human Resources team, the Human Resources Talent Acquisition Specialist will be responsible for leading the staffing efforts of Fujifilm Diosynth Biotechnologies Texas, LLC (FDBT) and building a strong workforce that adds to the company’s bottom line. This highly skilled Talent Acquisition Specialist should possess knowledge of employment and labor laws, have a deep understanding of the organization, its staffing needs, and possess strong interpersonal and communication skills. The HR Specialist will be expected to find potential candidates, screen, recruit, interview, and recommend the candidate for placement. The Talent Acquisition Specialist must be able to match candidate talents and qualifications for specific jobs in the biotechnology field. The process of recruiting may involve both internal and external sourcing methods, thereby requiring the Talent Acquisition Specialist to be adept at understanding where and how to locate candidates; able to source potential candidates through the local university and through various social media sites (e.g., LinkedIn), job boards, employee referral programs, state employment agencies, recruiting firms, etc.

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Lead QC Associate II

  • Research Triangle Park, North Carolina

We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.

The QC Lead Associate 2 will support a broad range of analytical disciplines within the Quality Control laboratory. This position will perform testing in the QC Analytical Chemistry laboratory. The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with minimal supervision. They are expected to follow procedures and have familiarity and proficiency with a wide variety of analytical methods and supporting data management processes. The individual effectively and efficiently manages complex or difficult tasks. Analytical disciplines common to the laboratory include, but are not limited to: Chromatography, HPLC, Concentration determination, pH, Total Organic Carbon, Gel based protein separation, IEF, Plate Based Assay, and conductivity. The position primarily works with or may take direction from peers within the department, but may work more independently according to the scheduled workload. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter experts.

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Maintenance Planner/Scheduler

  • College Station, Texas

Summary: The Maintenance Planner/Scheduler under the supervision of the Manager, Maintenance Operations is responsible for the planning, scheduling and performance of the maintenance program including the oversight of the Computerized Calibration & Maintenance Management System (CCMS/CMMS) in support of multiple manufacturing facilities such as the National Center for Therapeutic Manufacturing (NCTM), the Texas Biological Facility (TBF) and the Flexible Biological Facility (FBF) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). Primary responsibilities include managing the daily maintenance operations such as screening of incoming work orders, identification of job requirements, procurement of equipment and specialized tools, scheduling of maintenance staff, parts inventory control and monitoring of maintenance tasks performance. This position will interact with other maintenance and technical trades, such as manufacturing operators, engineers, calibrations technicians, validation, quality and external suppliers in order to provide a high level of excellence over the maintenance operational activities of FDBT.

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Manager, Commercial Development (East Coast)

  • Research Triangle Park, North Carolina

Fujifilm Diosynth Biotechnologies U.S.A., Inc. is seeking a Manager, Commercial Development to identify and manage the initial qualification and close through the signing of a letter agreement new business with new customers for clients on the East Coast.

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Manager, Downstream Manufacturing – TBF 100

  • College Station, Texas

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

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Manager, Quality Control Chemistry

  • College Station, Texas

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

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Manufacturing Coordinator – FBF 200

  • College Station, Texas

The Manufacturing Coordinator assists the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor by developing and driving systems for readiness, compliance, and permanence of new knowledge. The Manufacturing Coordinator will assist in supporting the timely release and disposition of batches and other post-execution activities.

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Manufacturing Coordinator – NCTM

  • College Station, Texas

Summary: The Manufacturing Coordinator assists the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor by developing and driving systems for readiness, compliance, and permanence of new knowledge. The Manufacturing Coordinator will assist in supporting the timely release and disposition of batches and other post-execution activities.

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Manufacturing Supervisor – Upstream

  • College Station, Texas

Summary

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

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Manufacturing Supervisor, Downstream – FBF 200

  • College Station, Texas

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

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Materials Management Specialist (Temporary)

  • College Station, Texas

Summary: The Materials Management Specialist is responsible for drafting and implementing supply chain management procedures governing the receiving, warehousing, ordering, shipping and internal distribution of cGMP (current Good Manufacturing Practices) and non-GMP materials.

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Person In Plant (PIP) Coordinator

  • College Station, Texas

Summary: The Person In Plant (PIP) Coordinator’s primary responsibility is to host customers as FDBT’s Person in Plant (PIP) escort to enable customers to observe critical operations during execution of their manufacturing process. The PIP Coordinator will serve as the customer’s primary contact when on site.

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Principal Biotechnology Process Scientist

  • College Station, Texas

Summary: The Principal Biotechnology Process Scientist functions within a team environment to actively address complex issues within a Contract Development & Manufacturing Organization (CDMO). The individual is responsible for analyzing process technologies in support of new project proposals and will serve as the project technical transfer lead. The individual is also responsible for designing and preparing process characterization and process validation programs and protocols. These programs require working with cross functional teams including customer groups and internal members from process development (upstream and downstream), analytical method development/qualification and manufacturing.

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Process Maintenance Lead Technician

  • College Station, Texas

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

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Process Maintenance Technician III

  • College Station, Texas

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

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Process Sciences – Engineer I

  • College Station, Texas

Summary: The Engineer I functions within a team based organization to actively address complex cGMP manufacturing issues. The individual is responsible for analyzing process technologies in support of new project proposals and assist in the technical transfer into the manufacturing group. This individual must work in a collaborative manner coordinating the transfer of biological drug processes from process development (internal or client) groups in a CMO environment.

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Process Sciences – Engineer II

  • College Station, Texas

Summary: The Engineer II functions within a team based organization to actively address complex cGMP manufacturing issues. The individual is responsible for analyzing process technologies in support of new project proposals and assist in the technical transfer into the manufacturing group. This individual must work in a collaborative manner coordinating the transfer of biological drug processes from process development (internal or client) groups in a CMO environment.

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Process Sciences – Technician I

  • College Station, Texas

Summary: The Biotechnology Process Sciences Technician I functions within a team based organization to actively address cGMP manufacturing requirements. The individual’s main responsibility is to obtain documentation for cGMP appropriate materials (raw materials and components), prepare item specifications for these materials and track the completion of the specification paperwork. The individual will also assist with other cGMP pre-production activities such as the selection of cGMP appropriate materials and equipment as directed. This individual must work in a collaborative manner to assist the transfer of biological drug processes from process development (internal or client) groups in a CDMO environment.

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Process Sciences Assistant – Part-Time

  • College Station, Texas

Summary: The Process Sciences Assistant will work in direct contact with the Process Sciences and Project Management staff to facilitate the acquisition, and organization of process material certificates of compliance and related information.

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Process Sciences Engineer I

  • Research Triangle Park, North Carolina

The Process Scientist/Engineer I represents the technical operations department before FDBU customers, regulatory agencies and management. This individual will manage the new client process and ensure project objectives are completed. The Process Scientist/Engineer will also contribute to the technology transfer of multiple projects at various project life-cycle stages (clinical material to commercial supply). Additionally, this individual must possess strong process understanding to implement and execute process risk review and process/cleaning qualification and validation activities.

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Process Sciences Engineer II

  • Research Triangle Park, North Carolina

We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.

The Process Engineer II will represent the technical operations department before FDBU customers, regulatory agencies and management. This position will manage the new client process, ensure completion of project objectives, and contribute to the technology transfer of multiple projects at various project life-cycle stages (clinical material to commercial supply). Additionally, the Process Engineer II will implement and execute process risk review, process/cleaning qualification and validation activities.

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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 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 Program Director ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission (strategy and compliance).

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QA Associate II (Document Control)

  • 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 the Document Control team responsible for quality and compliance document processing, handling, and archival.

Primary responsibilities will be processing documents in the EDMS, filing GMP records, issuing documents as requested, and processing documents for offsite archival.

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QA Manager, Product Release/Operations

  • Research Triangle Park, North Carolina

The QA Manager is responsible for specific quality and compliance areas within Quality Assurance for a site. Manage Quality Assurance systems and staff to meet site quality and compliance expectations.

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QA Technical Specialist (Software Validation)

  • 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 Quality Assurance group at Fujifilm Diosynth Biotechnologies is seeking a highly motivated individual to join us as a QA Technical Specialist in our Contract Manufacturing site located in Research Triangle Park, NC. The responsibilities related to this position are mainly software validation and QC Instrumentation validation support from a QA perspective.

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QA Technical Specialist, Analytical

  • 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 QA Technical Specialist will meet quality an compliance expectations for assigned areas on time, right-first-time and implement assigned compliance improvements.

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QC Supervisor

  • 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 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.
Primary responsibilities will be to supervise and coordinate staff performing analytical testing support for processes and products manufactured at the RTP site. This individual will provide technical leadership to staff to support routine testing by a variety of methods including ELISA, Western Blot, SDS-PAGE, Capillary Electrophoresis, RP-HPLC, SEC-HPLC, peptide mapping and other techniques. They will be the primary contact for the Quality Control laboratory, collaborating with staff outside of the department, facilitating timely and right first time data management and reporting, and assuring testing is completed in support of manufacturing timelines.

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QC Supervisor (2nd Shift)

  • Research Triangle Park, North Carolina

We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.

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

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QC Supervisor, Microbiology

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

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Quality Control – Cell Biology Analyst II

  • College Station, Texas

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

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Quality Control – Cell Biology Analyst III

  • College Station, Texas

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

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Quality Control Chemist I

  • College Station, Texas

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

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Quality Control Chemist I

  • College Station, Texas

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

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Quality Control Chemist II

  • College Station, Texas

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

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Quality Control Chemist II

  • College Station, Texas

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

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Quality Control Chemist III

  • College Station, Texas

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

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Quality Control Stability Coordinator

  • College Station, Texas

Summary : The Quality Control Stability Coordinator will be responsible for carrying out supporting activities on the stability program according to current regulations. This includes working with Clients to draft stability protocols, physically setting up stability studies according to respective stability protocols (staging), updating and maintaining stability planning/scheduling tools, ensuring timely execution of stability pulls at each time point, ensuring timely execution of in-house or external testing, writing summary reports, and ensuring the timely delivery of customer-oriented data and documentation.

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Research / Senior Research Scientist – Downstream Processing

  • United Kingdom, Wilton

Fujifilm Diosynth Biotechnologies specialises in developing manufacturing processes for customers biologic drugs and offer stability studies to support customer drug substance and drug products.

With plants in Billingham, Wilton, North Carolina, and Texas 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 grow we are recruiting 2 scientists for Downstream in our Process Development department within FUJIFILM Diosynth Biotechnologies, Wilton, UK in a brand new, state of the art facility.

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Scientist II, Microbial

  • 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 Upstream Process Development group is seeking a Scientist II with experience in microbial and recovery technologies. A 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.

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Senior Engineer, Manufacturing IT Systems

  • Research Triangle Park, North Carolina

FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Senior Engineer for Manufacturing Automation and IT Systems. The position will deliver day to day operations support as well as execute his/her project work in line with stakeholder’s expectations. The automation group consists of 3 – 4 automation engineers supporting manufacturing, process development, and facilities/maintenance.

Reporting directly to the Sr. Automation Manager, the Senior Engineer is responsible for supporting the day-to-day operations as well as implementation of new technology and modifications to existing systems aimed at cost reduction, efficiency improvements, system sustainability, and quality/safety enhancement.

The automation group has direct ownership of the site automation systems including both ABB DCS (MOD300 and 800xA) and DeltaV DCS, BMS (JCI and Siemens), PLC (Allen Bradley and Siemens), and OSI-Pi data historian.

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Senior Manufacturing Lead – Downstream

  • College Station, Texas

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

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Senior Manufacturing Lead – Upstream

  • College Station, Texas

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

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Senior Process Scientist/Engineer

  • 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 Senior Process Scientist/Engineer. Join our team of passionate engineers and scientists as we drive cutting-edge biopharmaceuticals from R&D lab to commercialization. Our Senior Engineers are responsible for many aspects of technical transfer of a wide variety client projects into our manufacturing facilities. From first clinical batch, to PPQ, to Pre-Approval Inspection – you will be there. No two days are alike. Our Senior Engineers troubleshoot complex technical issues to support project success. Senior Engineers provide comprehensive technical solutions throughout the organization. If you are ready to grow your career, work hard, and make a substantial impact in patients’ lives, consider joining our team.

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Senior QA Manager (LIMS)

  • Research Triangle Park, North Carolina

We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.

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

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Senior QA Manager, Regulatory 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.

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

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Senior Scientist, Microbial

  • 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 Upstream Process Development group is seeking a Senior Scientist with experience in microbial and recovery technologies. A Senior Scientist independently designs, executes and interprets complex laboratory experiments and development activities with broad priorities set by supervisor to achieve project goals. The individual demonstrates an application of scientific knowledge to projects and possesses a solid theoretical understanding within their own scientific discipline.

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Senior Scientist, Protein Formulation Development

  • Research Triangle Park, North Carolina

The Formulation Development Group, positioned within Analytical Development, is seeking an experienced Senior Scientist to oversee the continued implementation and expansion of our automated formulation development robotics platform. This position calls for a strong team player who is comfortable working in a fast-paced environment and enjoys the challenges associated with lab automation, in regards to both sample preparation and complex biophysical analysis.

The primary role of the successful candidate will be the operation the Freeslate Biologics Platform robotic system, maintaining the system to a high degree of quality, troubleshooting, interfacing with the vendor to overcome software and hardware challenges, and continuing to expand on our current use of the system into more advanced applications. The candidate will be the subject matter expert for all aspects of the robotics platform. Secondary to this role (and depending upon prior experience) the senior scientist in this position will be trained on all biophysical equipment and in the assessment of structure and stability of protein molecules based upon light scattering techniques, thermal and chemical stability, sub-visible particle analysis and spectroscopy. Future opportunities may include formulation development for alternate bio-therapeutic modalities dependent upon business growth.

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Senior Validation Engineer

  • Research Triangle Park, North Carolina

The Senior Validation Engineer is a high-level position in the Validation department of FDBU. This position will directly report to the Associate Director of Manufacturing Technology & Support, but may also have a functional reporting relationship to a senior colleague on a project-to-project basis.

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Sr. Automation Engineer (Saturn)

  • College Station, Texas

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

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Sr. Principal Scientist Group Leader, Upstream Process Development

  • College Station, Texas

Summary: The Sr. Principal Scientist Group Leader, Upstream Process Development, functions independently and productively in the Upstream Process Development Group actively engaged in process development within a team-based PD laboratory to support a wide variety of vaccine development projects.

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Sr. Training Specialist

  • College Station, Texas

Summary:  This position is responsible for the design, development, maintenance, and delivery of technical training for the Manufacturing organization.  Prepare training design documents and manage instructional design projects.  Create and own the train-the-trainer program. 

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Staff Process Scientist/Engineer

  • 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 Staff Process Scientist/Engineer. Join our team of passionate engineers and scientists as we drive cutting-edge biopharmaceuticals from R&D lab to commercialization. Our Staff Engineers are responsible for technical transfer of a wide variety client projects into our manufacturing facilities. From first clinical batch, to PPQ, to Pre-Approval Inspection – you will be there. No two days are alike and your level of ownership for projects will be high. Our Staff Engineers direct much of the technical activity of multiple projects and troubleshoot complex technical issues to support project success. Staff Engineers provide leadership to junior members and provide comprehensive technical direction throughout the organization. If you are ready to grow your career, work hard, and make a substantial impact in patients’ lives, consider joining our team.

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Supply Chain Coordinator

  • College Station, Texas

Summary: The Supply Chain Coordinator will develop and maintain integrated production planning and scheduling that encompasses materials to assure that supply targets are met. This position will be responsible for ordering and buying materials as well as tracking production and material consumption in applicable systems.

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Technical Engineer – Mechanical

  • United Kingdom, Billingham

Fujifilm Diosynth Biotechnologies specialises in developing manufacturing processes for customers biologic drugs and offer stability studies to support customer drug substance and drug products.

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

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Technical Project Leader/Senior Technical Project Leader 

  • United Kingdom, Billingham

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, North Carolina, USA 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 Technical Project Leader to join the Company.

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Trade Show Coordinator (Cambridge, MA)

  • Cambridge, Massachusetts

FUJIFILM Diosynth Biotechnologies is looking for a proficient and dependable Trade Show Coordinator to join our global marketing team to support trade show and event management to be located in Cambridge, MA. This individual will be responsible for coordinating and supporting our Sales Team at international or national industry trade shows and at local regional events. Additional duties include pre-conference preparation, post-conference reporting, and to work with a keen eye to advance all processes which requires meticulous detail to make the department stronger and more effective.

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.

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Training Specialist

  • College Station, Texas

Summary: This position is responsible for assisting with the design, development, maintenance, and delivery of technical training. Assist in preparing training design documents and managing instructional design projects. Create and own specific train-the-trainer programs.

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Upstream Manufacturing Technician I

  • College Station, Texas

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

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Upstream Manufacturing Technician II

  • College Station, Texas

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

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Upstream Manufacturing Technician III

  • College Station, Texas

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

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Upstream Production Technician (Day Shift)

  • Research Triangle Park, North Carolina

Fujifilm Diosynth Biotechnologies U.S.A., Inc. is seeing an Upstream Production Technician. The successful candidate will be performing cell culture sterilization techniques, support mammalian cell culture manufacturing processes, sustaining purification of bio-pharmaceuticals, operate various process equipment, documenting daily manufacturing operations in a cGMP environment, working with single- use and stainless steel bioreactors, fermentation, and/or filtration. This is a day shift position (7:00 am – 7:00 pm).

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Upstream Production Technician (Night Shift)

  • Research Triangle Park, North Carolina

Fujifilm Diosynth Biotechnologies U.S.A., Inc. is seeing an Upstream Production Technician. The successful candidate will be performing cell culture sterilization techniques, support mammalian cell culture manufacturing processes, sustaining purification of bio-pharmaceuticals, operate various process equipment, documenting daily manufacturing operations in a cGMP environment, working with single- use and stainless steel bioreactors, fermentation, and/or filtration. This is a night shift position (7:00 pm – 7:00 am).

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Utilities Maintenance Technician I

  • College Station, Texas

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

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Utilities Maintenance Technician II

  • College Station, Texas

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

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Validation Manager

  • College Station, Texas

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

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Validation Project Manager

  • College Station, Texas

Summary: The Validation Project Manager will be responsible for managing the execution of multiple validation related projects at FDBT facilities.

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Validation Specialist I

  • College Station, Texas

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

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Validation Specialist II

  • College Station, Texas

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

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Vice President, Commercial Development (North America)

  • Research Triangle Park, North Carolina

FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (FDBU) is seeking a highly motivated individual for a Vice President, Commercial Development, North America. The successful candidate will Co-develop and maintain FDB Global Sales and Marketing strategies aligned with FDB budget and growth plans; implement sales strategies in North America; provide leadership to the FDBU site as part of the SLT.

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Virology Technician II

  • College Station, Texas

Summary:

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

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