The Staff Accountant 2 supports the organization with accounting and finance related responsibilities by performing accounting analysis, preparing appropriate accounting and internal control documents. The Staff Accountant II plays a key role in understanding and interpreting customer contracts for accurately reporting and recognizing revenue. Additionally, this position interacts with and supports many of the accounting and finance areas of responsibilities

The Tech 1, Instrumentation & Controls (I&C) role is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility-wide equipment, and facility systems through effective Corrective and Preventive (CAPA) Maintenance and Calibration practices and know-how.

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 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 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 Senior Engineer/Scientist 2 will serve as a subject matter expert and provide technology transfer support and technical oversight during manufacturing operations.

The Senior Engineer/Scientist 1 will serve as a subject matter expert and provide technology transfer support and technical oversight during manufacturing operations.

The Engineer or Scientist 2, Material Science supports the design of new single-use consumables in conjunction with our manufacturing teams. This role assists the leachable and extractables program, that includes facilitation of testing based on products evaluated. This role also supports manufacturing investigations involving material science (e.g., raw material variability and concerns, consumable issues and particle sources). The role writes investigation reports and leachable and extractable reports.

The tech transfer role includes the management and coordination of activities for products transferred into large scale manufacturing facility, from first campaign through commercialization (clinical through process performance qualification/commercial). This involves managing between different teams, ensuring compliance with regulations, and optimizing processes for efficient transfer of knowledge and technology.

The Director, Automation is responsible for setting the direction and managing a central workstream in a $2 billion global project. This includes developing and executing plans to enhance operational efficiency, streamline processes, and leverage technology for improved performance. As the Director, this role bridges the gap between technical expertise and business objectives to drive innovation, efficiency, and execution. Additionally, this role ensures that the right people are assigned to the right tasks and projects providing challenge and enhancement to their skills.

The Supply Chain Specialist 1, Compliance is responsible for supporting 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 defined in the Pharmaceutical Quality System. The SC Specialist 1, Compliance assists with initiation and investigation of internal and external exceptions impacting Supply Chain, supporting the establishment, and implementation of comprehensive corrective and preventative actions (CAPAs) 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...

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 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 Supervisor, Manufacturing Support is responsible for leading the material, training and production scheduling teams within manufacturing support and their associated activities to ensure compliant and reliable production.

The Supervisor, Drug Product Form & Autoclave supports start up and operational activities for the site. This role leads a shift team and is responsible for the manufacturing process and facility which will eventually operate in a 24/7 model.

The Clean Utilities Engineer 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.

We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams who are willing and able to work on a DAY SHIFT (Approximately...

We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams who are willing and able to work on a NIGHT SHIFT...

The Raw Material Sampler 3 position is responsible for sampling of materials and products at the Holly Springs FDBN large scale manufacturing facility, which produces Drug Substance (DS), Drug Product (DP), and Finished Goods (FG) products. This role works with multiple functions to support operations: Warehouse, Supply Chain, Quality Control (QC), and other customers, as needed. The Raw Material Sampler 3 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).