Purification/Buffer Supervisor

Downstream (Purification & Buffer) Process ImprovementsTechnical data collection, correction, implementation to process improvementsWriting/editing technical documents, SOPs, ManualsCollaboration with mutli-departments (Eng, Automation, Maint., QA) to ensure cGMPs and improve process Cadence CAPA/ eCC, Deviation Initiation, follow throughLead technician on the floorBackup Supervisor when supervisor is out/busy

Bristol-Myers Squibb - Large Scale Pilot Commercial BiotechnologyLarge Scale Start-up/Commercial Manufacturing Facility; Commissioning a new Pilot Plant from Process Validation runs to FDA site approval Converting a single-drug facility into a multi-drug facilityShift lead to 5 techniciansQualified Trainer - SME PurificationCross-training in buffer prep; (but not limited to)Syncade Automation and EBR software along with Delta V platformSME/Leader of on-the-floor purification operationsWrite/Revise SOPs, Electronic Batch Records, Electronic Change Controls, Deviations, CAPA investigationsLarge scale Chromatography, UFDF, Tangential Flow Filtration, Viral inactivation, Viral Filtration, Aseptic Bulk Fill2 Meter Pall Chromaflow Columns

UNICORN administratorMain Duties include: (but not limited to)Shift Lead - 3 technicians in Purification, 3 technicians in Support ServicesDisposable TechnologyBatch Record Redesign Program – Played a lead role in this Shire programUNICORN Administrator (chromatography operating software) – write/revise methods, update and backup all computer files, manage programmed methods, set up user accounts/passwordsCommissioning/Validation: GE CPS50 column packing stationPack/Unpack columns: Using BPG, Chromaflow, and Axichrome columns Deviations: Initial, create, and close them UFDF: Installation of membranes, NWPs, Concentration/diafiltration activities CIP/SIP of mobile tanks, UFDF systems SOPS/Batch Records – Write new and revise all, Batch record review Validation – Working with engineering/validation to get 2 new AKTA process chromatography skids online (one for purification, one for cell culture recovery) Provide synergy between Buffer prep and Purification for scheduling of buffers

Main Duties include: (but not limited to) Creating new Purification Batch Records/ Editing existing Batch Records Create new SOPs/ Edit existing SOPs - Creating/Editing cGMP Forms/Logbooks Deviations - Initiating/ Investigating/ Closing deviations/ proofingValidation - IQ/OQ on a Lancer Glass Washer in Central Services Aseptic Inoculation Column packing/unpacking/ HETP Analysis UFDF - small and large scale Aseptic Final Formulation of Drug Substance - small scale Process Development - work with PD on new Purification process for Stage III clinical trials, scaled up from stage IIB clinical trials

Main Duties include: (but not limited to)CIP/SIP systems - medium scale tanksProtein chromatography/ Protein purificationUNICORN/DCS softwareUFDF operationAseptic bulk fill - large scaleBatch record/GMP document/SOP editing and review Collection of process samplesMaintenance, preparation and cleaning of manufacturing areas and equipmentProcess changeover, cleaning validation

Main Duties include: (but not limited to) CIP/SIP systems - large scale tanks Protein Chromatography/ Protein purification Process changeover, assist with several different products in suite cGMP - Learning guidelines for cGMP manufacturing