The Sr. Engineer, Quality Assurance is responsible for establishing and maintaining a robust and efficient Technology Transfer program at the Holly Springs, NC site. This position is responsible for ensuring the quality and compliance of initial Technology Transfer (TT) activities and supporting the continuous improvement and ongoing success of the TT lifecycle. This position interacts cross-functionally with Manufacturing, Supply Chain, Quality Control, Process Sciences, Validation, and various Client functions to ensure Quality objectives and initiatives are effectively delivered in a phase compliant manner.

The Supply Chain Planner 3 role supports the project phase and operations of GMP Purchasing and Supply Chain Planning at FDBN to ensure that the right
materials are available at the right time, in the correct quantity to support process validations and GMP production. This role supports the materials
planning process and direct purchasing while liaising with both internal and external stakeholders on the status of material readiness. This role is
responsible for supporting the planning team and orchestrating associated tasks to start up, while transitioning into commercial operations, including, but
not limited, establishing standard operating procedure, reports, material plans, manage projects and stakeholder relationships. The role collaborates
closely with all stakeholders across the FDB to setup accurate master data for both material and production planning in the SAP ERP system.

The Supply Chain Compliance Specialist 2 is responsible for actions, processes, and audit readiness at FDBN. This role supports all Supply Chain operations,
procedures, systems, processes, and GXP related matters in accordance with the GXP requirements defined in the Pharmaceutical Quality System. Support
includes initiation and investigation of internal and external exceptions impacting Supply Chain, supporting the establishment, and implementation of comprehensive corrective and preventative actions to prevent recurrence and drive improvements, coordinating vendor change notifications, raw material
enrollment and supplier complaints. This role coordinates internal and external changes impacting Supply Chain planning, master data, warehouse and
logistics, and customer requirements.

The Upstream Engineer/Scientist 2 will provide tech transfer support and technical oversight for a large-scale cell culture in monoclonal antibody manufacturing.

The Engineer / Scientist 3, Downstream MSAT will provide tech transfer support and technical oversight for large scale purification activities for Monoclonal antibody production.

This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required.  This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

The Associate Manager of Instrumentation & Controls (I&C) ensures the efficiency and operational reliability of the site instruments through an effective calibration process. This role sets the direction and manages the development of the I&C team as the site transitions from construction to operations. Additionally, this role assists with establishing efficient programs designed fit for future operations by utilizing current Good Manufacturing Practice (cGMP) / Good Laboratory Practice (GLP) knowledge, work scheduling, instrument calibration, repair, and troubleshooting. This role also provides day-to-day oversight and development of the I&C team. This position will require working 2nd shift.

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. Do you enjoy working in the evening, his role is for our 2^nd shift team, working 2pm to 10pm!

The QC Analyst is responsible for the key operational aspects of the QC Microbiology laboratory. Incumbent will perform microbial testing of all in -process drug substance, drug product, EM/UM, and raw materials samples. Incumbent will be responsible for all associated activities associated with this testing in accordance with written procedures. This position primarily works under minimal supervision as needed. This position will initially be involved in the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments will be required. This may include writing or assisting with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and on-boarding of new staff as needed and in addition to regular work duties and assignments.

The Mfg. Support Associate 3 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.

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.

The Manufacturing Specialist 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.   

Utility Maintenance 2 will perform corrective maintenance, routine maintenance, and preventive maintenance on plant utilities equipment following Standard Operating Procedures (SOPs). Complete work orders, daily logs and forms following Good Manufacturing Practices (cGMP) documentation practices and quality standards in a Pharmaceutical Manufacturing plant. Utilities to include high-pressure steam boilers, process wastewater treatment, chillers, water purification systems (water softening and carbon bed filtration, reverse osmosis, deionization equipment, sanitary pumps, and associated equipment), compressed air and dryers, and chilled water

The Tech 3, 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.

This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

The Project Manager role provides project management and communications support for complex, critical projects related to the development and operation of a greenfield Biotech Manufacturing facility. The primary focus is on establishing and facilitating continuous improvement and risk management initiatives to ensure the new site is adequately prepared for both initial startup and ongoing operations. This position leads, facilitates and participates in both internal and client-facing meetings to deliver tasks in support of the facility startup and ongoing operations.

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.