- Charles River Laboratories (Rockville, MD)
- …culture, staging of raw materials, seed train, bioreactor set up, fermentation monitoring and/or harvest). + Downstream Activities (eg, cell lysis, chromatography ... purification, centrifugation, Tangential Flow Filtration (TFF), and final formulation steps). + Fill-Finish Activities (eg, buffers and solutions filling, capping, labeling, gathering, and preparation of equipment and materials for final drug product). +… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …the primary technical subject matter expert (SME) for upstream processing (cell culture/ fermentation , harvest). + Lead and manage the technical aspects of upstream ... process technology transfers to CDMOs, including documentation review, gap analysis, and risk assessment. + Provide expert technical oversight of upstream manufacturing operations at CDMOs, including review of batch records, deviation investigations, and… more