- Fujifilm (Holly Springs, NC)
- …open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one ... start-up of new facilities + Biopharmaceutical, Active Pharmaceutical Ingredient, Finished drug product or Good Manufacturing Practices (GMP) experience + OSHA 10\30… more
- Fujifilm (Holly Springs, NC)
- …open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one ... or start-up of new facilities + Biopharmaceutical, Active Pharmaceutical Ingredient, finished Drug Product (DP) or Good Manufacturing Practices (GMP) experience + 8+… more
- Fujifilm (Holly Springs, NC)
- …open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one ... qualified and validated per standards and regulatory requirements (eg, Food & Drug Administration (FDA)) * Reads piping & instrumentation diagrams (P&IDs) to… more
- Merck (Durham, NC)
- …is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance . Focused areas of responsibility include but are not limited ... to activities of: Media Preparation, Fermentation, Tangential Flow Filtration, Process Monitoring, Sampling, and area cleaning. **Responsibilities may include but are not limited to;** + Support operations production through start-up and commissioning and… more
- Fujifilm (Holly Springs, NC)
- …open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one ... roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy,… more
- Fujifilm (Holly Springs, NC)
- …responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing (DSM) processes through to operational readiness during ... project phase. This role is responsible for quality assurance oversight of day-to-day activities and resolution or mitigation of issues. This role works 12-hour day shift on a 2-2-3 cadence, 0600-1800. **Job Description** **What You'll Do** * Performs an SME… more
- Fujifilm (Holly Springs, NC)
- …**Preferred Requirements** * Experience with Customer Relationship Management * Prior drug substance or manufacturing experience, including process validation, ... transfer, commercialization, and manufacturing support and troubleshooting. * Experience using quality systems (eg, deviation management system, change control, corrective and preventive action (CAPA), document management system) * Prior experience in leading… more
- Fujifilm (Holly Springs, NC)
- …open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one ... roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy,… more
- Amgen (Holly Springs, NC)
- …team to design, build, commission, and qualify equipment and systems needed for drug substance production as well as developing domain expertise to support ... operations upon start up. + Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design… more
- Amgen (Holly Springs, NC)
- …biotechnology companies, is investing $550 million to build a new multi-product drug substance bio manufacturing facility in Holly Springs, North Carolina, ... a bio manufacturing "hub" known for their life sciences industry. The new plant will combine two production formats, traditional stainless-steel fed-batch and single-use technology. This combination of capabilities is an approach that Amgen calls "FleX Batch"… more
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