- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …+ Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues. + Knowledge of ... the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka's products are… more
- Lilly (Durham, NC)
- …US and global regulations + Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of ... Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines… more
- Fujifilm (Holly Springs, NC)
- …responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during project phase through to operational ... of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The QA Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This ... lifecycle, with a focus on consistent policy administration. The QA Specialist, Drug Substance Manufacturing (DSM) ensures QA oversight of day-to-day activities… more
- Fujifilm (Holly Springs, NC)
- …of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and ... execute QC analytical chemistry methods used in biological product manufacturing , including chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis,… more
- Fujifilm (Holly Springs, NC)
- …for sampling of materials and products at the Holly Springs FDBN large scale manufacturing facility,which produces Drug Substance (DS), Drug Product (DP), ... of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and… more
- Fujifilm (Holly Springs, NC)
- …of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and ... engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory,… more
- Lilly (Concord, NC)
- …understanding and relevant experience of scientific principles required for manufacturing of parenteral drug products within operations, microbiology, ... provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level. + Lead or provide technical oversight for activities… more
- Grifols Shared Services North America, Inc (Durham, NC)
- …quantitative analysis. 4. Lead the characterization of critical process elements to support the manufacturing of novel drug substances and drug products. 5. ... The position supports all facets of Research & Development (R&D) and Manufacturing on a global scale, contributing to product development, manufacturing … more
- Fujifilm (Holly Springs, NC)
- …of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and ... of experience * Experience with Customer Relationship Management * Prior drug substance or manufacturing experience, including process validation, transfer,… more