Kate Boucher Email & Phone Number

Cranston, Ri, Us

Thousand Oaks, Ca, Us

Thousand Oaks, Ca, Us

Seeds and Perfusion, Production & Harvest (PPH)

Cambridge, Massachusetts, Us

Produced linearized plasmid DNA for drug candidates; personalized cancer vaccine applications; Pre-clinical, and Clinical platforms for further downstream RNA production.• Collaborated with Technical/Process Development Engineers for manufacturing qualification/Tech. Transfer of large-scale Purification and small-scale DNA operations.• Lead for generating and establishing processing supply materials for small-scale and large-scale DNA Manufacturing• Qualified Trainer for all aspects of small-scale DNA operations and lead for large-scale Purification and column packing qualification and operations. • Site EHS Representative • Worked with external contractors for initial setup and equipment qualification activities • Coordinated inventory process orders and general supply SAP reservations • Successfully executed and completed comparability batches to support the transition from a small process development lab in Cambridge, MA, to small-scale personalized cancer vaccine GMP manufacturing suites, and large-scale GMP Inoc,, Fermentation, and DNA Purification suites.• Produced Pre-clinical plasmid in order to facilitate the transition of the Pre-clinical team to Norwood.

Boston, Massachusetts, Us

Produced a monoclonal antibody (complement inhibitor) within in a commercial facility in compliance with the FDA and other regulatory/quality agencies. Performed operations in accordance with cGMPs and GDPs.• QT and SME for Purification and Buffer operations and served as Downstream operations and training night shift lead for a small team (4-6), with minimal to no supervision • Performed multi-stage, large-scale chromatography, column packing and qualification operations for standard Purification chromatography columns; pre-viral & post-viral product purification utilizing viral filtration and viral inactivation/titration operations; Ultrafiltration/Diafilitration operations via tangential flow filtration and membrane cassette installations; and bulk drug substance fill operations• Executed equipment set-up/preparation, cleaning via Clean in Place (CIP) operations, and sterilization by Steam in Place (SIP) operations • Prepared small and large-scale buffer solutions• Ensured process equipment is appropriately maintained for operation and troubleshooted process/equipment issues • Participated in cross-functional teams for protocols, investigations, forward processing decisions, process improvements, troubleshooting and production scheduling• Knowledgeable in aseptic technique/processing and executed in-process and non-routine sampling. Rinse and swab sampling qualified to support Validation activities, protocols, and deviation investigations• Drafted, revised, and reviewed SOP's, forms, protocols, and MBR's. Assisted in change control and CAPA implementations and procedural updates. Performed daily review of documents for compliance, and GDP accuracy• Ensured cGMP compliance within manufacturing suites, supported safety and inspection readiness at all times, and lead Internal Audits and tours • Collaborated with TMS personnel for the creation of a compliant Process Data Management System (PDMS)

Boston, Massachusetts, Us

• Supported transition to a 24-hour facility and helped to reduce batch run rates from 21 days to 14 days• Assisted in equipment derouging and remediation activities when necessary• Assisted in Upstream UF process improvements and validation activities

Boston, Massachusetts, Us

• Worked with Automation, TMS, and contractors for transition to a new Plant Control System (PCS)

Assisted a heating, ventilation, and air conditioning/refrigeration (HVAC/R) Master Technician in the field. • Provided general service, preventative maintenance, installation, and removal of oil, gas, refrigeration, and AC equipment under general supervision.• Diagnosed and aided in the troubleshooting of oil burner service problems under supervision.• Coordinated and installed duct work, flex piping, and line sets for heating, cooling, and mini-split systems. • Initiated, organized, and expedited company invoices and work orders.