Project Manager, Cash Management is responsible for overseeing FUJIFILM Biotechnologies cash management as the company expands from $1.5B to $5.5B over the next 5-6 years. This role requires a deep understanding of factors influencing FB's cash flow, including capex, opex and working capital. The individual will lead improvement initiatives to enhance the cash conversion cycle and provide strategic solutions to the CFO and Executive Leadership Team including being able to articulate the drivers behind cash challenges and opportunities.

The Associate Director, HS drives the implementation and enhancement of FUJIFILM Diosynth Biotechnologies world-class Environment, Health, Safety and Sustainability (HS) programs. This role is pivotal in fostering a culture that prioritizes employee well-being and safety across all operational facets. The AD, HS is responsible for ensuring compliance with regulatory standards while nurturing a proactive safety culture that emphasizes the importance of putting people and the planet first in all engagements.

The Senior System Manager role is part of diverse Global IT department, which is driving digital transformation across the organization. As part of the Global ERP & Enterprise Services team, this role plays a key role in maintaining and developing the DSM Scheduling System, crucial for streamlining our drug substance production. This role also collaborates closely with team to ensure efficient, compliant IT services, working primarily with SQL, Alteryx, and Tableau. This role captures deployment requests, develop new system features, and strategize alongside our global team. Our culture, defined by Genki, champions simplicity, agility, and a community thriving on diversity and complex challenges.

The Regional Associate Director, Finance Business plays a pivotal role in providing financial leadership and strategic support to the commercial and program management teams within our North Carolina sites. This position requires a blend of financial expertise, business acumen, commercial mindset and the ability to influence and drive strategic initiatives. This role leads the local Finance Business Partner team in supporting all financial elements relating to revenue recognition, contract review/approval and sales to program margin analysis and forecasting. They are also responsible for ensuring financial goals are met and business strategies are effectively implemented. This role requires an experienced commercially minded and driven individual with managerial experience.

The Sr. Supply Chain Planner 1 oversees the full life cycle of material management, while ensuring the operations of GMP Purchasing and Supply Chain Planning. The role leads collaboration with multiple departments to ensure the right materials are available at the right time, in the correct quantity to support GMP production. The Sr. Supply Chain Planner 1 clearly communicates expectations of delivery plans to Manufacturing, Process Science, Tech Transfer, and Quality. This role supports the operations of GMP Purchasing and Supply Chain Planning, including coordinating with the planning team and orchestrating associated tasks to start up and transitioning into commercial operations. The Sr. Supply Chain Planner 1 is expected to partner closely with all stakeholders across the FDB and Supply Chain teams to set up accurate master data for both material and production planning.

About the Role

The Scientist 1, QC Chemistry is responsible for QC analytical chemistry methods used in biological product manufacturing, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The Scientist 1, QC Chemistry ensures GMP-compliant laboratory operations in accordance with regulatory guidelines. This role performs technical/compliance reviews and approves analytical results. The role approves laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs).

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

Sr. Specialist 1, QC Lab Support works under moderate supervision, supporting and participating in QC activities related to investigations, deviations, OOS/OOT, CAPAs, and Change Controls. This role assists in creating and maintaining GMP documents and processes, collaborating with stakeholders and QA. This role contributes to customer contact and CLO communication to support QC capabilities in delivering materials and results. This role helps ensure QC compliance with policies and procedures. This role participates in project management and process improvement initiatives, developing skills in risk assessment. The role requires the ability to work effectively both independently and as part of a team, with growing cross-functional collaboration.

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 QA Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Drug Substance Manufacturing (DSM) ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.

The Manager, QC Lab Support is responsible for leading the Lab Support team and the associated activities to ensure compliant and reliable testing for drug substance and drug product. This role applies broad knowledge and expertise in the areas of biopharmaceutical Quality Control for QC Chemistry, QC Bioassay, QC Microbiology, etc. and operational excellence. This Manager, QC Lab Support provides tactical and strategic direction to the QC Lab Support team and promotes the behaviors and principles that drive continuous improvement throughout the organization.

The Automation Engineer 3 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 leading the Automation scope for delivery of DeltaV logic for CIP & Clean Utilities process areas including Clean-in-Place (CIP), WFI (Water-for-Injection) Generation and Distribution, WPU (Process Water) Generation and Distribution, Clean Steam Generation, and Waste Collection.

As part of our Global Finance team, you’ll partner with senior leaders, playing a critical role in our growth journey. You will have a comprehensive understanding of all the services offerings of our business, the markets in which we operate and our asset capabilities and profitability. This role focuses on partnering with global functions to evaluate new investment opportunities, whether through growth or acquisition. You will build financial models, challenge assumptions, develop scenarios with an understanding of risks, and enhance financial awareness and influence decisions to achieve four times revenue growth by 2030.   

The Technician 1, Maintenance is responsible for assisting installation, maintenance, and repair of process related systems/equipment. Ensure these systems meet the stringent requirements of pharmaceutical manufacturing. Also responsible for conducting regular inspections and preventive maintenance on process related equipment to ensure equipment is operating efficiently with minimal downtime.

The Manufacturing Specialist 2, SAP performs manufacturing support activities to ensure compliant and reliable production. This role focuses on aspects of recipe configuration and troubleshooting related to Systems, Applications, and Products in Data Processing (SAP) material transactions. This manufacturing facility will be 24/7 operational and the role may require flexibility with working days and/or nights and shift rotation.

The Manager, QC Laboratory Information Management System (LIMS) is responsible for developing strategic plans for implementing FDB's global Laboratory Information Management System (LIMS). This role harmonizes processes across all current and future FDB sites and leads the transition of QC into a paperless environment. The Manager, QC LIMS guides a team of LIMS experts to translate global and site-specific needs into user requirements, system design, configuration, and implementation plans. This role acts as the primary subject matter expert (SME) for LIMS and focuses on maintaining and continuously enhancing the global LIMS system.

We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams.   

These roles will execute manufacturing processing steps and associated activities when operational. You will also participate in operational readiness projects and commissioning/qualification projects. Our brand-new facility will be 24/7 operational. We will have a day shift and a night shift. We are hiring for night-specific roles; however, all roles may require flexibility with working hours and/or shift.

We operate on a 2-2-3, 12 hour shift schedule (days or nights).

*** Please note that this posting represents multiple openings ***