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.

Summary:   A unique opportunity to build and 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 Process Development, ready to embark on a new journey with us to build a new facility 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.

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

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 Process Development, ready to embark on a new journey with us to build a new facility 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.   This position will sit in Boston, MA. 

We are hiring for a Strategic Growth Business Project Manager (internally known as a Drug Product, Laboratory & Ancillary Services and SymphonX BSG Lead) These are truly exciting times for Fujifilm Diosynth Biotechnologies. Expectations for the growth of FDB by our owners, FUJIFILM Corporation and Mitsubishi Corporation remain high and we continue to deliver on these expectations. With our continued successes come an increasing appetite for further investment in our people, facilities and technology to help accelerate growth in order to meet the increasing demands of the Market and drive towards the BioCDMO target of reaching $1Bn revenue by the end of FY2021.    In order to ensure that strategies for growth across our various service offerings are clearly defined and communicated, the Executive Leadership Team, via the VP Enterprise Business Planning will be establishing a number of Business Steering Groups (BSGs) that will oversee the strategic direction of our core business domains globally, as One FDB. At present they are: Cell Culture, Microbial, Viral Gene Therapy, Laboratory Process Characterization and Analytical Services, Drug Product and Assembly Label and Pack, SymphonX. More BSGs may be developed as the company grows.   This is a global position that will support all four sites (FDBU, FDBT, FDBK, and FDBD). This position can be based at any of our locations around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site.

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

The Commercial Development Manager is to support the VP Commercial Development in development, maintenance and execution of strategies to strengthen the commercial pipeline emanating from the Asian territory.   This is a global position that will support all four sites (FDBU, FDBT, FDBK, and FDBD). This position can be based at any of our locations around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site.

Did you know we are growing our Diosynth division?  To support this growth we are hiring for a Talent Acquisiton Recruiter (internally known as a Sr. Talent Acquisition Recruiter) for a future site in Holly Springs, NC.  As the Talent Acquisition Recruiter you will play a vital role in shaping the organzation, while providing an excellent experience for each FUJIFILM candidate.  Qualified candidates will work with the Talent Acquisition Team and provide support throughout the day-to-day full life cycle recruiting process.

The QC LIMS Developer is accountable for support of the Laboratory Information Management system (LIMS) in accordance with appropriate regulatory, corporate, and scientific guidelines. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success.

We are seeking a team of Senior Engineers within the CUB/QC labs/WHs in our journey to establishing the largest End-to-End cell culture CDMO provider in North America but more importantly, someone who wants to be a part of the largest growth journey that we in Fuji Film have ever entered. Be a part of the future. Today.   You as the Senior Engineer in the CUB/QC lab/WHs work package will be responsible for leading the engineering and construction activities for the new facilities in a $2 billion global project. We offer the possibility of being a part of the CUB/WH building work package, with a responsibility depending on your background. You will be responsible for securing that your area in the future buildings is structured, designed, engineered and constructed in a way that lives up to the expectation of future operations.

We are seeking a Head of Environmental, Social, and Governance (ESG) Sustainability in our journey to establishing the largest End-to-End cell culture CDMO provider in North America but more importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. Be a part of the future. Today.   You as the Head of ESG (Sustainability) will drive the ESG strategy and its execution in a $2 billion global project. We offer the opportunity to be part of a journey where FUJIFILM strives to be a model company for life science/biotech manufacturing globally by pursuing zero environmental impact and work with the local community in resolving environmental and social issues. You will collaborate and coordinate across functions, and be responsible for ensuring that the entire project deliver on ESG/sustainability.

We are seeking a Head of Finance in our journey to establishing the largest End-to-End cell culture CDMO provider in North America but more importantly, someone who wants to be a part of the largest growth journey that we in Fuji Film have ever entered. Be a part of the future. Today.   You as the Head of finance will be responsible for setting the direction and managing the Finance activities in a $2 billion global project. We offer the responsibility of building and driving the finance function in the Galaxy project – overseeing the finance and accounting transactions in the project and providing a transparent overview of the financial results.    We are looking for someone with positive energy, entrepreneurship and courage to empower and inspire others. You will join an organization with focus on growth, you will have a steep learning curve but most essential there is a focus on people first and what you can bring to the table. We have a diverse workplace for people driven to make a difference.

We are seeking a Head of Building, Drug Substance Manufacturing in our journey to establishing the largest End-to-End cell culture CDMO plant in North America but more importantly, someone who wants to be a part of the largest growth journey that we in Fuji film have ever entered. Be a part of the future. Today.   You as the Head of Building, Drug Substance Manufacturing will be responsible for setting the direction and managing the engineering and construction activities for the new facilities in a $2 billion global project. We offer the possibility of creating and leading the CSA team, and you will act as the leader of the team and work package owner with your management skills strong CSA background. The focus of the job will be on either Drug products (DP), Drug substance manufacturing (DSM) or finish good manufacturing (FGM). You will be responsible for securing that the future buildings are structured, designed, engineered and constructed in a way that lives up to the expectations of future operations.

We are seeking a Head of Building Drug Product and Finished Goods Manufacturing in our journey to establishing the largest End-to-End cell culture CDMO plant in North America but more importantly, someone who wants to be a part of the largest growth journey that we in Fuji film have ever entered. Be a part of the future. Today.   You as the Head of Building Drug Product and Finished Goods Manufacturing will be responsible for setting the direction and managing the engineering and construction activities for the new facilities in a $2 billion global project. We offer the possibility of creating and leading the CSA team, and you will act as the leader of the team and work package owner with your management skills strong CSA background. The focus of the job will be on either Drug products (DP), Drug substance manufacturing (DSM) or finish good manufacturing (FGM). You will be responsible for securing that the future buildings are structured, designed, engineered and constructed in a way that lives up to the expectations of future operations.

We are seeking a team of Senior Process equipment Engineers in our journey to establishing the largest End-to-End cell culture CDMO provider in North America but more importantly, someone who wants to be a part of the largest growth journey that we in Fuji Film have ever entered. Be a part of the future. Today.   We offer the possibility of playing a central role in the Process Equipment work package in a a $2 billion global project. Your specialist focus could be on Upstream, downstream, media/prep, CIP/water etc. depending on your background.

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

The Buffer Prep Coordinator (internally known as Buffer Inventory Coordinator) is responsible for managing buffer inventory by developing inventory management systems, performing regular inventory audits and analyses, forecasting stock levels and needs (supply and demand requirements), and coordinating the logistics to ensure consistent stock levels.  The buffer inventory coordinator will be meticulous in inventory control to manage buffer inventory for Manufacturing at FDBU.  Complete support for the right first time execution of manufacturing per locked schedule.

Summary:  The Manufacturing Manager, Upstream – NCTM is responsible for assisting in the planning, directing, and coordinating of the activities related to the Upstream manufacturing processes for the National Center for Therapeutics Manufacturing (NCTM) while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics.  The Manufacturing Manager, Upstream will oversee the cGMP production and Upstream manufacturing systems working 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.

Summary: The Director, Program Management will be responsible for the planning and delivery of programs from the point of contract signature (Scope of Work/Letter of Intent/Contract) to project delivery including technology transfer, and taking a product/process from execution of a client commercial agreement or memorandum of understanding through process development and early stage clinical supply through program closure.  The Program Director ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission (strategy and compliance).