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About the Role
The Sr. Specialist 2, QC Program Management Technical transfer (TT) and Sample Support (SS) provides technical support through effective project management of the QC Sample Plans and QC Specifications in close collaboration with relevant stakeholders, including customers. The Sr Specialist 2, TT/SS interfaces with customers to scope QC Sample Plans and QC Specifications. This role participates in and leads collaborations with cross-functional teams as a representative of QC. This role supports the timely completion of project milestones and deliverables. This role supports GMP compliant laboratory operations in accordance with regulatory guidelines and participates in audits and inspections.
The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation
The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.
The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.
This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required. This position will ensure drug product manufacturing start up phase is supported from a knowledge standpoint and will then help the supervisor lead the manufacturing effort after start up phase.
The Manufacturing Associate 2 executes and documents manufacturing processing activities per cGMP environment. This manufacturing facility will be 24/7 operational and the role will require working a 12 hour shift on a 2-2-3 Night Shift.
This role performs 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 Automation Engineer 3, DSM Downstream will provide support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. This role focuses on supporting the delivery of DeltaV logic for Downstream process areas including Buffer Preparation/Hold, Purification – Chromatography (LPC), Viral Filtration (VF), Ultrafiltration (UF), Diafiltration (DF), and Dispensing.
The Automation Engineer 3, DSM PI Data Historian, will provide Engineering input on the design, implementation, configuration, and testing qualification of the hardware for an Emerson DeltaV control system. Once in Operations, you will be responsible for and have ownership of the ongoing support of the control system hardware, software, and infrastructure.
The Automation Engineer 2, DSM DeltaV Infrastructure, will provide Engineering input on the design, implementation, configuration, and testing qualification of the hardware for an Emerson DeltaV control system. Once in Operations, you will be responsible for and have ownership of the ongoing support of the control system hardware, software, and infrastructure.
The Senior Active Directory Engineer has a critical role in ensuring the global Active Directory environment is secure, scalable, and reliable. Key responsibilities include:
This role requires a strong technical background and leadership skills to effectively manage and mentor the team while ensuring the integrity and security of the AD environment
The Associate Director, Cleaning Validation is responsible for leading and executing Cleaning Validation (CV) 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 collaborates with cross-functional teams to drive continuous improvement and optimize CV practices.
The Process Analyst is tasked with analyzing, documenting, and performing gap analysis on finance processes across six sites within the group. This position supports project managers in finance transformation projects and exists to optimize workflow efficiency, enhance cross-functional collaboration, and identify and assess alignment of existing processes. Engaging with various departments, the Process Analyst facilitates sessions for process mapping and optimization, establishes and maintains governance structures, ensuring a cohesive future approach across the organization.
The Finance Transformation Project Manager plays a pivotal role in managing and executing finance-specific projects within Fujifilm Biotechnologies. This role involves overseeing complex, strategic financial change initiatives and process improvements that contribute to the success Fujifilm Biotechnologies, 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.
The Senior Director of Operations Excellence will be a key leader in Fujifilm Biotechnologies across several areas of the business. The role will be responsible for identifying, planning, and driving improvements across all sites in the business. These improvements will include, but not be limited to, productivity increases, costs savings, revenue increases, and systemic process changes. The role will also have a significant hand in shaping the strategy of the Operations Excellence (OpsExc) team and its agenda for the next 2-3 years.
The ideal candidate will have deep experience working across all levels of an organization to gain alignment to their vision, and in working in a matrixed fashion to execute the plans they jointly develop with stakeholders. The role requires technical expertise (conceptual, analytical, and quantitative problem solving), strong stakeholder management, and an ability to be efficient in actions, communications, and organization.
This role has no direct or in-direct reports.
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