The Investigator 2 is responsible to perform major investigations, identify root and contributing causes, contributes to the creation of effective corrective and preventative actions (CAPA) while ensuring timely closure of assigned investigations. This role also supports senior investigators with complex investigations as needed and provides guidance to junior investigators.

The Scientist 2, QC Chemistry is a technical subject matter expert (SME) 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 2, 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 QC Chemistry Scientist II authors, reviews, and approves SOPs, protocols, and technical reports. The role serves as the subject matter expert (SME) for QC Chemistry in cross-functional projects and meetings.

The Manufacturing Specialist 1, 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 Director, Drug Substance Manufacturing (DSM) plays a critical role in the design, execution, and leadership of DSM Operations strategy for the Holly Springs site. This role is accountable for all upstream and downstream manufacturing operations, ensuring safe, compliant, and successful delivery of life changing therapies for patients. The Director, DSM guides leaders, develops high-performing teams, and works cross-functionally to ensure alignment with our global network, including our partner site in Denmark. This role influences the long-term success of our site and partners with top-tier biopharmaceutical companies to manufacture cutting-edge medicines that change lives.

The Sr. Analyst 1, QC Analytical Development (AD) Chemistry 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 Sr. Analyst 1, QC AD Chemistry 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 Sr. Analyst 1, QC Analytical Development (QCAD) Bioassay supports the implementation of plate and cell-based 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). This role supports the transfer and validation of methods such as residuals (HCP, DNA, Protein A), dot blot for product identity, ELISA ID/ Potency and various cell-based assays. The Sr. Analyst 1, QC AD Bioassay ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical method transfers from clients and author and review procedures, SOPs, and technical reports.

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 Production Scheduler, Drug Product Finished Goods is responsible for creating, maintaining, and optimizing daily and long-term production schedules across drug product manufacturing, filling, inspection, and packaging operations. This role ensures timely product delivery and efficient use of resources while adhering to current Good Manufacturing Practices (cGMP). Acting as a central coordination point, the scheduler partners with other departments (e.g., Manufacturing, Planning, Quality, Supply Chain) to align material availability, equipment capacity, and staffing needs with the production plan.

The Raw Material Sampler 2 position is responsible for sampling of materials and products. This role works with multiple functions to support operations (e.g., Warehouse, Supply Chain, Quality Control (QC)). The Raw Material Sampler 2 uses Systems and Applications Production (SAP) Enterprise Resource
Planning (ERP) system for inventory management and Laboratory Information Management System (LIMS) for sample management while operating in a good manufacturing practice (GMP) facility with standard operating procedures (SOPs).

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 and our manufacturing teams work 12-hour shifts (either days or nights) on a 2-2-3 calendar rotation.

*** Please note that this posting represents multiple openings within our manufacturing organization  *** 

The Manufacturing Associate 3 leads and executes manufacturing processing steps and associated activities.This manufacturing facility will be 24/7 operational and the role requires working a 12 hour shift on a 2-2-3 schedule. 

The Project Manager 2 is responsible for collaborating with internal and external stakeholders, including but not limited to Environmental, Health & Safety(EHS), Maintenance, contractors, vendors, and clients. This role is responsible to handle administrative aspects of the project from start to completion, track and monitor the project status and milestones, and ensure projects meets all standards, timelines, and budgets.

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 Day Shift.

The role as Manufacturing Associate 2 will execute and document manufacturing processing activities within a cGMP environment. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

Act as the local Compliance Officer for both of Fujifilm Biotechnologies sites in North Carolina region.  In addition, they will be the main Compliance contact / support for any questions / requirements for Fujifilm Biotechnologies.

The Sr. IT Engineer 1, CSV is the Subject Matter Expert (SME) and leads tasks associated with Computer System Validation (CSV). This role provides input and determine action items on all GxP Manufacturing and IT Computerized Systems as well as prepares validation documentation, maintains a validated state, with a focus on consistent policy administration. Additionally, this role works closely with other workstreams at FDBN and IT departments at other locations to align strategies and procedures. This role facilitates improvement initiatives, supports regulatory agency, and third-party inspections, as needed.

The Manager of CQV enables efficient tech transfer and new product introductions at the Holly Springs facility. This role is crucial for Upstream and Downstream process equipment (thaw to bulk fill) as it enables the right first time and on-time commercial production. This role provides technical expertise to the immediate team and other stakeholders, as needed. Additionally, this role leads a team of Engineers and provides coaching and direction.