- Fujifilm (Holly Springs, NC)
- …of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product ( DP ). This role supports projects which influence manufacturing processes for Drug Product ... Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may… more
- Fujifilm (Holly Springs, NC)
- …of new customer projects as they relate to QC Sample Plans and DS/ DP Specifications. * Authors, reviews, and leads updates of controlled GMP documents related ... inspections. * Collaborates with the LIMS team and IT department to build DS/ DP sample plan and specification functions that meet end-user and customer requirements.… more
- ThermoFisher Scientific (Greenville, NC)
- …or PhD. + 10 years of expertise in pharmaceutical processes, including DP characterization, stability profile understanding, and linking DP characteristics with ... bio-pharmaceutical performance. + A minimum of 5 years people leader experience, including technical and non-technical coaching and mentoring. + Knowledge and experience with both current and new technologies in chemical synthesis, biologics, and new… more
- Fifth Third Bank, NA (Charlotte, NC)
- …introduction to market. + Vendor selection and relations; contract negotiations (Business partners DP & Ops). + Market research and analysis. + Maintain and enhance ... knowledge, current and evolving concepts, practices, processes, laws/regulations, and technologies in financial management. + Conduct market segment studies - product development Understand and analyze competition in all Affiliate Markets. + Perform market… more
- Fujifilm (Holly Springs, NC)
- …FDA regulations + Experience in Drug Substance Manufacturing (DSM), Drug Product( DP ), and/or Finished Goods Manufacturing (FGM) + Prior experience leading projects ... and/or teams **Preferred Requirements** + Master's degree in Chemical Engineering, Computer Engineering, Computer Science, Biological Science, or related fields, with 3 years of direct Computer System Validation experience in a cGMP pharmaceutical facility… more
- Fujifilm (Holly Springs, NC)
- …* Ensures analytical testing of in-process, drug substance (DS), drug product ( DP ), and stability samples is performed according to appropriate GMP regulations. * ... Ensures analytical testing data is captured in LIMS software and data integrity is maintained. * Reports assay performance and assists with implementing improvements that ensure quality and efficiency within QC Chemistry. * Identifies and follows up on… more