- 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
- Amgen (Holly Springs, NC)
- …as part of Amgen's plan to be a carbon-neutral company by 2027. Front Line Manufacturing Manager (Downstream) - Night shift **What you will do** Let's do this. ... vital role you will be an on-shift front line manager in manufacturing , specifically in the area...5+ years of knowledge and process experience within a cGMP manufacturing facility or other highly regulated… more
- Merck (Durham, NC)
- …responsible for using principles of our Company Production Systems, Lean Laboratories, and cGMP requirements in the laboratory. The Manager will manage the team ... quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an… more
- Merck (Durham, NC)
- … Manager will be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start-up method transfer/validation ... its global Bacillus Calmette Guerin (BCG)_vaccine production by adding an end-to-end manufacturing and laboratory building in a new facility located in the Durham,… more
- Fujifilm (Holly Springs, NC)
- …is responsible for agile quality partnerships that proactively assure Quality and cGMP Compliance. The Manager , QA Learning applies their technical expertise ... more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to...function delivers and maintains a compliant training program. The Manager , QA Learning acts asthe learning lead for GxP… 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 ... Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate… more
- Fujifilm (Holly Springs, NC)
- …designed fit for future operations by utilizing knowledge of current good manufacturing practice ( cGMP ) and good laboratory practice (GLP) compliance, utility ... **Overview** **Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO** The work we do at FDB has never been more… more
- BD (Becton, Dickinson and Company) (Mebane, NC)
- **Job Description Summary** POSITION DESCRIPTION POSITION TITLE: Sr. Manager , Operations DEPARTMENT: Manufacturing COMPANY: BD Diagnostics - Diagnostic Systems - ... Dr., Mebane, North Carolina 27302 REPORTS TO: Associate Director, Plant Operations (Plant Manager ) The Sr Manager , Operations is responsible for the leadership… 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 ... Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate… more
- Fujifilm (Holly Springs, NC)
- …Springs, North Carolina, United States. **External US** **About This Role** The Associate Manager of DSM leads a team of manufacturing associates (MA's) for ... manufacturing bulk drug substance. The Associate Manager is responsible for the departments training and regulatory...defined cadence with direct reports *Maintains a safe and cGMP compliant environment by ensuring direct reports have correct… more
- United Therapeutics (Research Triangle Park, NC)
- …and quality goals + Coordinate alignment of design deliverables with construction manager 's procurement plan to ensure alignment + Establish and maintain cultural ... + Manage the equipment procurement process including monthly reports from construction manager that reference need by dates from project schedule, vendor back up… more
- Fujifilm (Holly Springs, NC)
- …work plans and detailed project schedules + Experience working in a cGMP manufacturing facilities + Project Management Professional (PMP) **Working Conditions ... Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO** The work we do at...United States. **External US** **About This Role** The Project Manager 2 is responsible for collaborating with internal and… more
- Lilly (Durham, NC)
- …Responsible for shop floor execution as it relates to business plan, CGMP conformance and Operational Standards for Manufacturing Excellence. **Basic ... within the area and developing the technical expertise of manufacturing employees. This individual must ensure that the ...ensuring that direct reports are Trained and Qualified per CGMP guidelines. + Act as both administrator and technical… more
- Eurofins (Raleigh, NC)
- …drug development process and all functional areas of bio/pharmaceutical manufacturing , including method development, microbiology, process validation and quality ... control. Position Summary Eurofins BPT is seeking a results-oriented Regional Sales Manager to join our team, focusing on facility validation and environmental… 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
- Cardinal Health (Raleigh, NC)
- …Regulatory, and other technical and service providing functions on supplier quality, manufacturing , and product matters + Guide direct report team members to greater ... and avoid recurrence + Participating in transferring product designs to manufacturing (Design Transfers) and Mfg. site-to-site transfers and leading the… more
- Fujifilm (Raleigh, NC)
- …Irvine Scientific, Inc. adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company's ... to FUJIFILM Holdings Corporation. We are hiring a Marketing Manager , Bioscience and Pyrogen Testing (BSPT) . The BSPT...Bioscience and Pyrogen Testing (BSPT) . The BSPT Marketing Manager will oversee all marketing aspects of the marketing… more
- Merck (Durham, NC)
- …value to the achievement of team goals + Understand and apply cGMP /GLP, Compendial, and other applicable regulatory requirements toward analytical testing + ... Specialist, Quality Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product… more
- Lilly (Durham, NC)
- …HSE goals. + Ensures adequate qualified/trained staffing for operators working on the manufacturing lines. + Communicate with the area Manager on quality, ... for shop floor execution as it relates to business plan, current Good Manufacturing Practice ( CGMP ) conformance and Operational Standards for Supply Chain… more
- Merck (Durham, NC)
- …qualification/validation, equipment qualification, and technical quality support for sterile manufacturing of vaccines. The ideal candidate would have knowledge of ... responsibility as well as a thorough understanding of sterile manufacturing and background working with grade A,B, C and...peers. + Applies appropriate risk management while adhering to cGMP requirements. + Makes decisions guided by policies and… more