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.

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 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 Sr Automation Engineer 1 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.

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 Director, Operational Excellence is responsible for driving continuous improvement initiatives and promoting Lean Sigma methodologies across the manufacturing facility. This role leads the implementation and sustainability of process improvement projects, reduce waste, optimize processes, and ensure that the facility meets its operational goals with a focus on efficiency, quality and cost reduction. This role also helps to define, establish and nurture a continuous improvement culture. This role is responsible for defining what good looks like starting with establishing the foundations of a strong program, developing and rolling out the right tools to be used, training to help all levels of the facility adopt and embed and finishing with ongoing monitoring and performance mgmt. that drives continuous improvement in to our ways of working, identifying issues and mitigating risk to drive the site to be a high performing site that is ambitious to continuously do better than yesterday. 

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 Associate Director, QA for Materials, Supply Chain and QC will be responsible for the supervision of the Quality teams supporting release of materials, Supply Chain functions including warehouse as well as providing Quality oversight for the QC function via supervision ensure that materials released are tested in accordance with GMP regulations. Provides QA support for approval of specifications, documentation, reports, deviations, and changes coming from the QC function. Assures product compliance through Quality systems and effectively ensure initiatives that promote a robust Quality Culture within Quality function and for supporting functions. Proactively engage with the organization to drive continuous improvements within the team. As member of the site Quality leadership team contribute to cohesive execution of quality initiatives and projects throughout the site in Holly Springs.

The Automation Engineer 3, 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 supporting the delivery of DeltaV logic for Upstream process areas including Inoculum Lab, Media Preparation, Seed Culture, Large Scale Bioreactors, and Harvest.