- Fujifilm (Holly Springs, NC)
- **Position Overview** **Director, QA Drug Substance Operations** Are you a strategic leader with expertise in managing teams of QA professionals and collaborating ... seamlessly with manufacturing and support functions? If you are motivated and possess strong...in a world-class Quality organization as the Director, QA Drug Substance Operations. In this role, you will oversee… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, ... (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance… more
- Polaris Pharmacy Services, LLC (Charlotte, NC)
- …Procedure Manual and internal pharmacy policies. + Process IV orders when technical support is unavailable. + Answer drug -related questions about IV therapy and ... knowledge of the notification process for prescribers and facilities regarding drug interactions, allergies, and other adverse patient safety situations. + Perform… more
- Merck (Durham, NC)
- …small team, train others and contribute to process improvements. This position will support the vaccine drug substance site readiness through licensure and ramp ... up to full production. This position will support all Operations areas, including Purification. Off-shift coverage will...**Responsibilities may include but are not limited to;** + Support operations production through licensure and ramp up. +… more
- Fujifilm (Holly Springs, NC)
- …* Contributes to the preparation for operational readiness related to drug product manufacturing. * Possible assignments include supporting projects related to, ... creation, development or transfer of manufacturing business processes, testing and commissioning support . * Travel up to 0-25% (international or domestic) may be… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …of downstream operations through effective technology transfer, validation support , process monitoring, troubleshooting, and lifecycle management activities ... monitor performance, identify trends, and propose process improvements. + Support process characterization and validation activities (PPQ) for downstream processes… more
- Actalent (Durham, NC)
- …candidate will be responsible for executing and validating ELISA assays to support pharmacokinetic and anti- drug antibody analysis. This role is integral ... + Execute established MSD-based ELISA assays for pharmacokinetic (PK) and anti- drug antibody (ADA) analysis. + Perform GLP-level assay validation and bioanalytical… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …analytical methods (Biochemical, Immunological, Enzymatic and cell-based Methodology) necessary to support all phases of Drug development projects. This position ... is also responsible for characterizing process intermediates and drug products for current and novel biotherapeutics. The candidate will be responsible for authoring… more
- Amgen (Holly Springs, NC)
- …while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will ... The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Manager, QC Lab Support is responsible for leading the Lab Support team and the associated activities to ensure compliant and reliable ... testing for drug substance and drug product. This role...Microbiology, etc. and operational excellence. This Manager, QC Lab Support provides tactical and strategic direction to the QC… more