End-to-end supply chain management of our clinical cell & gene therapies.

Supervise and schedule the aseptic processing of commercial scale autologous cellular therapeutics. Aseptic processing includes biopsy digestion, cell feeding, passaging and expansion, harvest from ten layer cell stacks, cryopreservation, and final injection preparation.Contribute to Quality investigations, Corrective/Preventative Actions initiatives, Change Control procedures, technical protocols, and logistical planning

Formulation, sterile filtration and Aseptic filling of viscous Hyaluronan solutions in ISO 6 (class 1000) cleanrooms. Coordinated workflow, personnel support, and materials for Aseptic filling operations. Performed Factory Acceptance Testing and Site Acceptance Testing on new vial fill equipment. Provided process expertise and support to project management, quality engineering and other cross functional areas during new product/process development and validation activities.

Cell Culture and Purification of humanized mammalian cells to produce monoclonal antibodies. Authored batch records and standard operating procedures with a focus on bioreactor processing and recovery methods. Knowledgeable with commercial scale bioreactor processing; centrifugation and depth filtration; chromotography systems, liquid handling modules, ultrafiltration skids, and other 316s production vessels and disposable units.

•Completed commissioning tasks for commercial manufacturing facility•Cell Culture of mammalian cells to produce Monoclonal antibody•Performed daily batch cell culture production duties such as CIP, pressure hold, SIP, media filtration and inoculation of bioreactors •Viable cell counts using hemocytometer•Monitored physical, chemical and biological parameters•Conducted on-the-job training for new personnel•Performed all duties in compliance with current GMP’s, SOP’s and batch records

•Managed and coordinated all promotional activities for company's primary customer•Built relationships with vendor and customer accounts through daily customer service calls•Joint sales calls with account buyers for account penetration and to develop new business•Surveying, merchandising and resetting retail accounts•Attended seminars and trade functions designed to strengthen company position in marketplace