Summary The Quality Control Cell Biology Supervisor will be responsible for coordinating the installation and qualification of new analytical equipment in support of GMP release and stability testing.  The Cell Biology/Immunology Supervisor will lead tech transfer activities of qualified cell based and immunological methods from designated donor laboratories.  The Supervisor will play a pivotal role in selecting qualified personnel to staff the QC Cell Biology laboratory.  

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Senior Validation Engineer will report directly to the Associate Director, QA Validation at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for overseeing the development and implementation of validation strategies. They will perform analysis and compilation of data and resumes into summary and final reports.

The Trade Compliance Manager will be able to work with autonomy in relation to matters of trade compliance to achieve the strategic direction set by the FDB regional Directors of Corporate Compliance and in collaboration with the FUJIFILM Corporation regional headquarter teams at FUJIFILM Holdings America Corporation (“HLUS”) and FUJIFILM Europe (“FE RHQ”) (collectively the “RHQs”).

Competent operation professional responsible for performing tasks at predefined levels within projects or operations.  Tasks may be routine in nature, expertise generally limited to areas of responsibility.  Understands the “why” part of the job.  Demonstrates knowledge of internal customers and support area requirements.  

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.   The Upstream Operations Manufacturing Project Lead acts as the upstream operations representative supporting the design and construction through to routine production operations.  This individual will have some responsibility to hire, lead, and inspire manufacturing associates and supervisors during the project and into operations.

Primary responsibilities of the QC Technical Supervisor will be to test complex and critical analytical chemistry/biochemistry assays (50% of time) and to supervise and coordinate staff performing analytical chemistry testing and the associated laboratories (50% of time) in support of processes and products manufactured at the RTP site. This individual will provide technical leadership to staff to support routine testing including HPLC, UPLC, SEC, CE, iCiEF, Peptide Mapping, DNA Threshold testing, pH, Appearance, Western Blot, ELISA, HCP and other biochemistry and analytical chemistry tests. The role will be a 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.

The Head of Process Science will establish and lead our Manufacturing Science, Program Management & Tech Transfer interfaces to drug development partners at our Holly Springs site.  This is a one-of-a-kind opportunity to develop and define the future business model of what will be the largest cell culture manufacturing site in North America.  This senior leader will be essential in driving our new customer base as well as ensuring complete end-to-end Process Development and Manufacturing Science as Drug Product capabilities are being built to form an entire Process Science team.  They will function as the key overall customer interface for new products, processes and changes from partners and programs.  All strategic, tactical and operational aspects of the group will support the bulk drug substances and ensure close collaboration with Manufacturing, Global Engineering & Facilities, Quality, Regulatory, CMC, Business Development and Tech Development in meeting the business objectives.  The Head of Process Science will collaborate closely with our Denmark location to ensure alignment across key areas and will have full accountability for adherence to cGMP requirements and regulations.  This role will be highly visible in our community and our industry, and presents a unique chance to build something extraordinary.  

The QC Lead Associate, Data Reviewer position is a position that supports a broad range of analytical disciplines within the Quality Control laboratory. The individual performs data review for testing of 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 requiring data review 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 Validation Engineer II, under minimal supervision, will be responsible for drafting and executing utility, process systems and process support systems qualification test work across multiple GMP facilities as well as support cleaning and process validation when necessary. Preparing validation summary reports for the qualification and validation of systems used to manufacture drug or biologics products.

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 Sr. Quality Assurance Technical Specialist (Supplier and Materials Management) position is a senior technical professional that is a recognized authority within their specialized field.  It provides expert leadership for Quality System programs related to supplier and materials management that have significant scope within the organization.  The incumbent provides GMP and compliance oversight of supplier management and materials management and other assigned systems, as well as ensuring appropriate and timely technical review/approvals as required by the system.  As a Senior Technical Specialist, this role coordinates the execution creation, revision and creation of new materials as well as quality management of existing and newly proposed suppliers.  Cross functional interactions are a significant component of this job.

Summary:  Our engineering team in College Station, Texas is expanding, and we are looking for a Security System Administrator to be responsible for supporting, monitoring, and enhancing our security operations. The Security System Administrator will provide day-to-day security support operations to ensure electronic security systems, documentation, and procedures are followed and worked as expected. 

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

The Manufacturing Lead (Downstream) will oversee and perform cGMP manufacturing operations for manufactured biopharmaceutical products.  Ensure the effective use of material, equipment, and personnel while making products at high quality levels. Recognized as a subject matter expert with regard to manufacturing processes.

The Process Maintenance Mechanic II performs general/complex mechanical repairs to plant equipment and systems.  They perform routine mechanical troubleshooting and preventative maintenance (PM) tasks and promote a reliable process operation.

The work we do at FUJIFILM Diosynth Biotechnologies U.S.A., Inc.  has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDBU and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDBU calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDBU, you determine what’s possible.   As we grow our community, our capacity, and capabilities, we’re looking for passionate people to join our team. Our North Carolina site sits in the renowned Research Triangle Park, the United States’ largest hub of research and innovation. In such a dynamic location adjacent to many of the country’s best places to live, it’s no surprise that our passion is meteoric.   As a member of the Supply Chain organization, the Contract Master Data Coordinator is responsible for the creation and maintenance of item master material to support Fujifilm Diosynth Biotechnologies supply chain operations, ensuring business continuity, and accurate data quality. They will collaborate with business, operations, and technology stakeholders to utilize processes and workflows to build a strong data foundation for supply chain. Pioneer master data governance best practices with a focus in continuous improvement to promote growth and structure for daily supply chain operations. The Contract Master Data Coordinator will also be adaptable to assisting with business or IT projects to advise on master data topics and execute necessary activities.   This is a contract position scheduled to last at least 12 months offering benefits.

Summary:   A unique opportunity to lead a new state-of-the-art process development and manufacturing facility for viral vectors and advanced therapies in the greater-Boston area.   As a leading global Contract Development and Manufacturing Organization, FDB continues to grow and further accelerate offerings in viral vectors and advanced therapies. We are looking for a people, business, and technically savvy Head of Site, ready to embark on a new journey with us as well as to recruit and lead a high performing organization. The new facility will house experimental and analytical equipment for viral vector and advanced therapy process development, with contract manufacturing services for early phase clinical trials beginning at the site in fall 2023.   The Site Head will provide strong scientific, business and administrative leadership to Viral Gene Therapy process development and early stage cGMP manufacturing group at the Boston site, setting annual goals and objectives and long range planning.  The Site Head will provide high-level business strategy for the site, oversee the management of resources and coordinate activities across multiple departments to achieve business objectives and revenue goals.  This individual will serve as the strategic leader and an advocate for the site to the Viral Gene Therapy leadership team and will work to enhance the existing and establish new collaborations within the academia, pharma and industry communities to perform cutting-edge research and innovation in the field of advanced therapies.

Summary:  The Manufacturing Compliance Coordinator II assists with 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.  

Summary:  The Manufacturing Compliance Coordinator I 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.

The Chief of Staff will use strong leadership and problem-solving skills to assist with the daily operations and strategic planning of our newest site in Holly Springs, NC.   Reporting to the site head, this role requires the ability to organize, communicate, and delegate items that will result in the delivering this project on time and within budget.  They will serve as an air traffic controller for the leader and the senior leadership team; as an integrator connecting work streams that would otherwise remain siloed; as a communicator linking the leadership team and the broader organization; as an honest broker and truth teller when the leader needs a wide-ranging view without turf considerations; and as a confidant without an organizational agenda.

Summary:  The role of Site Head, Biologics Program Management is to lead the local Program Management team: - Sponsor and direct program delivery at Fujifilm Diosynth Biotechnologies to deliver on the commitments made to our customers and provide outstanding customer service. - Lead the site S&OP process to ensure that the site delivery plans are aligned with the budget, that the resource and asset strategies of the business are based on forecasts of customer demand while pro-actively identifying and mitigating risks.   No matter what role you play in FUJIFILM Diosynth Biotechnologies (“FDB”), you are part of a team that is having a profound impact on the lives of countless individuals and families across the globe.  The manufacturing processes that we develop and the medicines that we produce help protect, improve, extend, and save lives. We recognize that to maximize our impact and ensure the success of our customers and therefore the success of FDB, we need to build a diverse team of individuals that are driven by a passion that we call “Genki.”  Genki is personal, it’s your driving force to learn, grow, strive to do better, and strive to be better knowing that your work truly is positively impacting the lives of countless others around the world.   FDB is a Contract Development and Manufacturing Organization (“CDMO”) with the sole purpose to support our customers as they deliver on the medicines of today and advance the medicines of the tomorrow. The Program Management team are critical to the successful delivery of our customer’s programs and therefore the success of FDB through careful coordination and management of the vast resources across the FDB network including incredibly talented subject matter experts that each contribute to delivering on our commitments to our customers to advance tomorrow’s medicines.