The QC Analytical Development (AD) Chemistry Scientist 2 is responsible for coordinating the transfer of analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN). The QC AD Chemistry Scientist 2 ensures GMP compliant laboratory operations in accordance with regulatory guidelines. This role coordinates analytical method transfers from clients, including the following analytical methods: 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 QC AD Chemistry Sr. Analyst I works with limited direction to support the execution of analytical method transfers and validations for drug substance (DS) and drug product (DP) manufacturing into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN). The analytical chemistry methods used in biological product manufacturing include chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The QC AD Chemistry Sr. Analyst I adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical method transfers from clients and authors and reviews procedures, SOPs, and technical reports. The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success.

The Analytical Development (AD) Tech Transfer (TT) Scientist 2 manages and coordinates the transfer of drug substance and drug product QC analytical methods from customers into the large-scale manufacturing facility, from first campaign through commercialization (clinical through process performance qualification/commercial). This role interfaces with customers and cross-functional teams to scope analytical testing plans and achieve project milestones. This role authors/reviews transfer plans, method transfer documents, transfer summary reports and specification justification reports, as needed. This role effectively communicates and operates between different teams, ensuring compliance with regulations, and optimizing processes for efficient transfer of knowledge and technology.

The Technician 2, Maintenance is responsible for the 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 Tech 2, Instrumentation & Controls (I&C) is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility-wide equipment, and facility systems through effective Preventive and Corrective Maintenance and Calibration practices and know-how.

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are 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 FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

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 Clean Utilities Engineer 3 provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Clean Utilities, including reverse osmosis/electrodeionization (RO/EDI) skids, water for injection (WFI), purified water (WPU), Clean gasses and applicable waste systems. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with troubleshooting equipment issues to maintain overall plant reliability. Additional responsibilities includes supporting deviation investigations and documentation for associated system deficiencies.

The Black Utilities Engineer 3 provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Black Utilities, including Chilled Water Systems, Steam Boilers, Cooling Towers, HVAC and Glycol Chiller and Compressed Air systems. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with troubleshooting equipment issues to maintain overall plant reliability.

The Sr. Specialist 1, QC Technical Transfer 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 1, TT/SS interfaces with customers to scope QC Sample Plans and QC Specifications. This role participates in collaborations with cross-functional teams as a representative of QC. This role supports the timely completion of project milestones and deliverables. This role supports Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines and participates in audits and inspections.

The QC Instrumentation Specialist will work independently to perform routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program. This role will ensure compliance of QC analytical instrumentation with Data Integrity standards in accordance with regulatory guidelines and company policies and procedures. This role will ensure the performance of routine maintenance, completing periodic reviews of QC analytical instrumentation to confirm compliance and correct deviations and excursions. The role will also support stakeholders with issues and guidance related to QC analytical instruments. The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success. This role is included in routine on-call and weekend support, as needed.

The Supply Chain Specialist 3, Compliance is responsible for actions, processes, and audit readiness. This role supports all Supply Chain operations, procedures, systems, processes, and GXP related matters in accordance with the GXP requirements. The SC Specialist 3, Compliance initiates and investigates internal and external exceptions impacting Supply Chain. This role leads the implementation of comprehensive corrective and preventative actions (CAPA) to drive improvements, coordinating vendor change notifications, raw material enrollment and supplier complaints. This role coordinates and is responsible for leading internal and external changes impacting Supply Chain planning, master data, warehouse and logistics, and customer requirements. The SC Specialist, Compliance will be coordinating change management record (CMR) for new raw material enrollment, supplier complaints and vendor change notifications.

The Automation Engineer 2, DSM - CSV will provide support to the Drug Substance Manufacturing (DSM) facility. This includes preparing validation  documentation, contributing to the qualification of Drug Substance Manufacturing (DSM) GxP Automation Computerized Systems, and being a part of Automation on-call support as needed. This role will partner with other departments locally and other sites to align strategies and procedures. This role will be responsible for ensuring that all DSM GxP Automation Computerized Systems are maintained in a validated state throughout their lifecycle with a focus on consistent policy administration. Additionally, there will be involvement in facilitating improvement initiatives and supporting regulatory agency and third-party inspections.

The Vice President of Engineering will be a business leader for the site engineering function. This pivotal role will be responsible for overseeing the engineering functions, including Automation, Process Engineering, Utilities, Commissioning, Qualification, and Validation (CQV), Facility Management and Security, and Capital Projects. The executive role will join site leadership in leading the business and ensuring engineering teams support the business strategy and provide state-of-the-art technical solutions, support robust manufacturing processes, drive continuous improvement initiatives, and upholds the highest standards of quality and compliance across the Company network.

The role will ensure a strong connection to FUJIFILM Diosynth Biotechnologies' strategic priorities and create close connection between the sites in the network on engineering topics to create and share best-practices.

The Sr Automation Engineer 1, DSM Upstream 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 full Automation scope for delivery of DeltaV logic for Upstream process areas including Inoculum Lab, Media Preparation, Seed Culture, Large Scale Bioreactors, and Harvest.

The Instrumentation & Controls Technician is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility wide equipment, and facility systems through effective Preventive and Corrective Maintenance and Calibration practices and knowhow. While in project phase, the schedule will be M-F during normal business hours.  Upon transitioning to operations, this position will transition to the appropriate shift that will be defined prior to the transition. You will join an organization focusing on growth, people, and a steep learning curve as well as a diverse workplace with people driven to make a difference.

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. 

*NOTE: This posting represents 3 Openings*

This position reports to the Process Engineering Manager, Upstream in support of the Process Equipment team for the Galaxy project, a greenfield construction project in Holly Springs, NC.  The initial assignment is to assume the Responsible Engineer role for the Seed Train unit operations.

As the site moves into commercial operations circa 2025, this position is planned to continue as a Process Engineering role supporting commercial operations, technology transfers, and small capital projects related to the same unit operation.  Additional details regarding job responsibilities are below.

This position reports to the Process Engineering Manager, Downstream in support of the Process Equipment team for the Aura project, a greenfield construction project in Holly Springs, NC.  The initial assignment is to assume the Responsible Engineer role for Chromatography and Column Packing unit operations. 

As the site moves into commercial operations circa 2027, this position is planned to continue as primary support for Chromatography and Column Packing unit operations, with secondary responsibility expanding to cover additional Downstream unit operations includes supporting commercial operations, technology transfers, and small capital projects.  Additional details regarding job responsibilities are below.