- Merck & Co. (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 & Co. (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
- Merck & Co. (Durham, NC)
- …qualification/validation, equipment qualification, and technical quality support for sterile manufacturing of vaccines. The ideal candidate would have knowledge of ... referenced areas of responsibility as well as a thorough understanding of sterile manufacturing and background working with grade A,B, C and D area including… more
- 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
- Novo Nordisk (Clayton, NC)
- …of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable ... Nordisk's innovative oral products. At API, you'll join a global network of manufacturing professionals who are passionate about what they do. What we offer you:… more
- Novo Nordisk (Clayton, NC)
- …SOPs, regulations & ISO standards required + General knowledge in cGMP manufacturing & production processes associated with pharmaceutical companies ... Operate API manufacturing equipment to achieve production goals. Relationships Shift Manager , Operations - API. Essential Functions + Work in a safe &… 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
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and regions. **Monday - Thursday** **(2nd Shift)** **1:30pm - 12am** ** Manager , Supply Chain Operations** Manages Grifols' Plasma Supply Chain Operations activities ... of compliance, safety, and conformance to procedures that are specified by SOP's, cGMP 's, and OSHA standards. Primary Responsibilities for the Role: + Directs the… more
- Coty (Sanford, NC)
- …and deliver capacity, cost savings and safety/quality improvement initiatives within cGMP manufacturing and distribution at Coty Sanford. Specific deliverables ... Engineering Project Manager **ENGINEERING PROJECT MANAGER ** **SANFORD, NC**...+ _Develop and manage the engineering project work for manufacturing and distribution from scope development through implementation and… 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
- 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
- Pfizer (Sanford, NC)
- …OR a PhD with 0+ years of experience. + Thorough knowledge of cGMP (current Good Manufacturing Practices), combination device regulations, design control + ... You** Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital… 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
