The Director of Program Design will partner with the global commercial sales team, broader commercial organization and site technical/operations teams in support of acquiring new business for Fujifilm Diosynth’s large scale cell culture sites. They will lead technical discussions with potential clients projecting Fujifilm experience and expertise in this offering. They will develop and author customer-tailored proposals and assist throughout the sales process

The Scientist 1, Global QC Analytical Development Raw Materials is responsible for coordinating the transfer of analytical methods for raw materials into the FUJIFILM Biotechnologies Diosynth Quality Control Laboratory and external contract laboratory organizations (CLOs). This role liaises with customers, CLOs, QC testing teams, and QA groups to plan and track QC raw materials readiness for clinical and commercial manufacturing, which includes ensuring training needs, internal procedures, specifications, and protocols are met. This role ensures compliance with all GMP (Good Manufacturing Practices) regulatory guidelines. 

Summary: Laboratory Engineering Technical Support I is an entry-level position in the Laboratory Engineering department of FDBT.  The primary purpose of this position is to provide day-to-day technical support for the analytical pcs and equipment within Manufacturing, Quality Control, Analytical and Process Development organizations.  In addition, this position is a major contributor to supporting new technology and equipment life cycle monitoring.  Under...

The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally.  

The Sr. QC Data Reviewer is responsible for ensuring compliance with Fujifilm’s Quality systems, policies, and procedures in accordance with U.S. and international regulatory agencies, ICH, general cGMP, and international guidance. This role involves leading the data review process to ensure accuracy, thoroughness, and timely completion in collaboration with cross-functional departments. The incumbent must possess a strong understanding of systematic reviews and data integrity, with skills and experience in cGMP data review requiring multi-departmental collaboration.

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.  

The Manufacturing Support Associate 3 plays a crucial role in maintaining compliant and reliable production, with adhering to cGMP regulations and industry guidelines. This position leads compliance initiatives, oversees corrective and preventive action (CAPA) execution, and coordinates batch planning, all while ensuring seamless tech transfer and effective troubleshooting as a process subject matter expert (SME). The role demands flexibility in working hours to effectively support 24/7 production and accommodate inspections and audits.

The Associate 1, Quality Control (QC) Environmental Monitoring (EM) is an entry level position responsible for performing site environmental and clean utility monitoring within the manufacturing classified areas. This role performs routine laboratory testing and support activities in continuous improvement initiatives.

The Associate 1, Quality Control (QC) Environmental Monitoring (EM) is an entry level position responsible for performing site environmental and clean utility monitoring within the manufacturing classified areas. This role performs routine laboratory testing and support activities in continuous improvement initiatives.

The Associate Director of Commissioning, Qualification, and Validation (CQV) is responsible for leading and executing CQV activities for a large-scale biologics manufacturing facility in compliance with regulatory requirements, including 21 CFR Parts 11, 210, and 211, as well as ASTM E2500 guidelines. This role ensures that all facility, utility, equipment, and process qualification activities are conducted efficiently and in alignment with Good Engineering Practices (GEP) and Risk-based Validation approach. This role exists to guarantee the integrity and compliance of production systems and to mitigate risks associated with the therapeutic product lifecycle. The Associate Director, CQV...

As the IT Business Partner, you will drive the collaboration with business units to ensure IT aligns with local needs, serving as the primary contact for FUJIFILM Diosynth Biotechnologies (FDB) Global IT. You will drive the collaboration with Site leadership, FDB IT Functional areas, and Project Management to ensure seamless alignment with...

As a global finance businesspartner you will be responsible for the cost controlling and partnering of FDB global cost areas

Under general direction, the HR Associate will be responsible for coordinating the onboarding and orientation process for all employees and contractors hired at site.  The HR Associate will also help drive HR programs that focus on employees.  The successful individual in this role will ensure all the necessary actions behind the scenes are executed so that employees feel a seamless experience with the HR function.

The Client Coordinator Administrative Assistant will provide comprehensive assistance and support to the program management team as well as facilitating client-facing site visits and coordinating internal and external events. This role is key to ensuring smooth operations and exceptional client interactions while supporting client-facing teams in significant matters requiring their attention.

The Senior Investigator of Deviations Management for Drug Product Finished Goods (DPFG) is responsible to complete major and complex manufacturing investigations, identify root cause, and create effective corrective and preventive actions (CAPAs). This role engages with regulatory inspectors, internal auditors, and senior leadership, as needed regarding the findings of investigations. Additionally, this role mentors and provides guidance to junior investigators throughout the investigation process.

A proactive and driven team player is required to passionately support delivery and embedding of the Data Integrity projects at FDBT. The Quality Assurance (QA) Specialist II for Data Integrity will be responsible for the day to day running of the FDBT Data Integrity Program, performing data integrity assessments, gap confirmation and risk assessments, generate remediation plans and categorize gaps based on business priority and risks.  

The Warehouse Associate 1 position is responsible for storage, handling, and distribution of materials and products. This role supports Warehouse operations in receiving, shipping, and/or logistics. The Warehouse Associate 1 works with multiple functions to support operations (e.g., Manufacturing, Quality, Process Sciences, and other customers). This role uses SAP ERP system for inventory management, cycle counting, and shipping activities while operating in a GMP facility with standard operating procedures (SOPs). This role requires shift work and/or weekend hours to support operations and is

This role will perform manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours. 

This role will perform manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours. 

The Finance Transformation Project Manager plays a pivotal role in managing and executing finance-specific projects within FDB. This role involves overseeing complex, strategic financial change initiatives and process improvements that contribute to the success FDB, readying the business for 4x revenue growth by FY30. The incumbent will ensure efficient budget management, deliverable tracking, and financial system enhancements crucial for achieving long-term business objectives.