- Sumitomo Pharma (Morrisville, NC)
- …**Job Overview** We seek a dynamic, highly motivated, and experienced individual for the Manufacturing Manager , cGMP Manufacturing role. The ... isolators is preferred. + Experience at an FDA approved or late-stage cGMP manufacturing site + Experience in production batch record review, investigation of… more
- Novo Nordisk (Clayton, NC)
- …SOPs, regulations & ISO standards required + General knowledge in cGMP manufacturing & production processes associated with pharmaceutical companies ... records ensuring compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices ( cGMP ) standards + Manage individual training plan +… more
- Fujifilm (Morrisville, NC)
- …in GMP QA or similar role **Preferred Requirements** + Experience in Validation, CGMP Manufacturing Operations and/or Quality oversight in an FDA regulated ... **Position Overview** The Senior Manager , Quality Compliance is responsible for the day-to-day...for you. From our Bioprocess Innovation Center to our cGMP -compliant manufacturing site, we thrive on collaboration,… more
- Fujifilm (Holly Springs, NC)
- …efficient programs designed fit for future operations by utilizing current Good Manufacturing Practice ( cGMP ) / Good Laboratory Practice (GLP) knowledge, work ... **Position Overview** The Associate Manager of Instrumentation & Controls (I&C) ensures the efficiency and operational reliability of the site instruments through an… more
- Ingersoll Rand (Lillington, NC)
- …experience in related field. **Additional Experience Desired:** + Experience in contract Manufacturing for medical devices and/or custom cGMP chemical solutions ... For more information visit:www.irco.com. **Position Objective:** The Business Development Manager is responsible for providing commercial leadership for the … more
- Amgen (Holly Springs, NC)
- …Join us and transform the lives of patients while transforming your career. **Senior QA Manager ** **What you will do** Let's do this! Let's change the world! In this ... and qualified to perform their duties in accordance with cGMP and regulatory requirements. + Oversee workload distribution, resource...all use our unique contributions to serve patients! The Manager Quality Control professional we seek is a strong… more
- Amgen (Holly Springs, NC)
- …are manufactured, tested, stored, and + distributed according to current Good Manufacturing Practices ( cGMP ), Good Documentation + Practices (GDP) and other ... transform the lives of patients while transforming your career. ** Manager Quality Assurance - Plant Quality Assurance** **What you...the PQA team and will work directly with plant manufacturing and engineering staff during the Amgen North Carolina… more
- Fujifilm (Morrisville, NC)
- …the right place for you. From our Bioprocess Innovation Center to our cGMP -compliant manufacturing site, we thrive on collaboration, creativity, and purpose. ... **Position Overview** The Procurement Manager is responsible for executing procurement strategies and...Whether your expertise lies in research, manufacturing , or production, you'll find a home here where… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Associate Manager of DSM leads a team of manufacturing associates (MA's) for manufacturing bulk drug substance. The Associate ... 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging… more
- Grifols Shared Services North America, Inc (Raleigh, NC)
- …services in more than 110 countries and regions. **Job Overview:** The Quality Manager will provide support to the Technical Director to ensure compliance of Quality ... Operations, Regulatory and cGMP Compliance Program of Grifols USA. Generates records to...assurance/quality compliance experience working in a domestic and global manufacturing matrixed environment within a pharmaceutical, medical device, GMP… more
- Amgen (Holly Springs, NC)
- …your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest ... will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it...plan to be a carbon-neutral company by 2027. **Maintenance Manager - Night Shift** **What you will do** Let's… more
- Catalent Pharma Solutions (Morrisville, NC)
- **General Manager , Site Operations** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose ... time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing , Catalent supports the acceleration of development programs and… more
- Catalent Pharma Solutions (Morrisville, NC)
- **Senior Project Manager - Global Engineering** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing , Catalent supports the acceleration of development programs and… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Senior System Manager role is part of diverse Global IT department, which is driving digital transformation across the organization. As ... 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging… more
- Kelly Services (Clayton, NC)
- **Position Title:** Quality Control Environmental Monitoring Manager **Location:** Clayton, NC **Schedule:** Monday - Friday | 8:00 AM - 5:00 PM **Salary Range:** ... planning and oversight + Employee relations and staffing + Ensure compliance with cGMP regulations and department safety standards. + Provide expert guidance to … more
- Amgen (Holly Springs, NC)
- …skills + Successful experience working in a multi-plant and/or multi-site cGMP -regulated commercial manufacturing environment, or process development + Knowledge ... Join us and transform the lives of patients while transforming your career. EH&S Manager , Risk Management What you will do Let's do this! Let's change the world!… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Project Manager role provides project management and communications support for complex, critical projects related to the development ... andoperation of a greenfield Biotech Manufacturing facility. The primary focus is on establishing and...of operations readiness processes and project plans for site cGMP go live across the business functions and site… more
- GRAIL (Raleigh, NC)
- …For more information, please visit grail.com . GRAIL is seeking a Manager , Engineer Operations for the Engineering Operations Organization. The Manager , ... guide staff to support the area and operators' day to day following cGMP /GLP and Quality Management System (QMS) guidelines. + Lead root cause investigations, drive… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …operations, overall compliance, oversee department budget, employee relations,etc.). + Follows cGMP and department safety practices. + Provides guidance as well as ... consults with manufacturing and internal regulatory departments on GXP matters. + Uses expertise and sound judgment to make independent decisions within defined… more
- Eurofins (Cary, NC)
- …well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized ... + Supports administrative function by: o acting as the Deputy Quality Assurance Manager in their absence o responsible for assigning Quality Assurance group tasks as… more