Experience

REVANCE THERAPEUTICS LTD

• United Kingdom
• Retail Office Equipment
• 1 - 100 Employee

• Manufacturing Technician III

  • Nov 2020 - Present

  Revance Therapeutics, Newark, CA November 2020 – Present • Ensure compliance with established internal and external control procedures. • Working in an ISO 5 aseptic filling area with DaxibotulinumtoxinA using cRAB’s and glove ports. • Operation and troubleshooting of equipment. • Performs 100% visual inspection and packaging of final product. • Performs formulation operations inside a BSC. • Batch record reviewer. • Trainer for new employees and less experienced technicians. • Performs/Assists QC with Environmental Monitoring during Filling and Capping Operations. • Provides support for annual validations. • Work with support groups and performs Drug Product Manufacturing Operations scheduling, along with assigning daily tasks. • Created and maintained production cadence to increase operations and efficiencies. • Perform routine procedures following written instruction (SOPs, batch records, solution documents, protocols, etc) within controlled GMP environment and serves as the lead in these activities. • Support the continuous training of Drug Product Manufacturing Staff on procedures, aseptic techniques, equipment and trouble-shooting skills. • Review in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completion. • Work with team and support group on revising and originating production records, standard operating procedures, protocols and reports, Change Request, and CAPA. • Work with Quality Control, Facilities, Material Managements, Quality Assurance and Validation to complete assignments. • Drives ongoing continuous improvement within Drug Product Manufacturing Process. Show less



Genentech

• United States
• Biotechnology Research
• 700 & Above Employee

• Downstream Master Technician

  • Jul 2003 - Present

  •Review and respond to process anomalies, monitor issues and initiate resolution and/or discrepancies. Execute required actions associate with the discrepancy such as facilitate root cause analysis, update standard operating procedures, submit work notifications, and review batch records. •Deduce production schedule and assign tasks to manufacturing technicians. Adapt to changes in team headcounts and production workload to maximize efficiency, safety, and quality. •Work collaboratively with various support groups to align production process flow, to schedule equipment maintenance and validation study, and to troubleshoot and to resolve production issues. •Review and monitor production orders and work instructions. •Execute validation procedure for new and existing process and equipment such as CIP/SIP, freeze/thaw skid, change over cleaning/rinse water sampling, and various autoclave sterilization cycle recipes. •Perform large scale production processes under aseptic condition: aseptic connections, sterile filtration, aliquot, dilution and buffer formulation. •Perform environmental monitoring using Climet particle counter and microbial air sampler, and rinse water sampling. •Provide trainings to manufacturing technicians. •Proficient using SAP, a Computerize Material Management System (CMMS). •Design process improvement projects and data analysis on production operations. •Team roles/involvement: o ICOS Total Productive Maintenance Team Captain: Adherence to schedule increased from 30% to 70%, process discrepancies reduced from 30% to 6%, work notification request decreased from 6.30 to 2.75 per month. o Herceptin Inventory Team Bulk Lead: worked in a small team to increase Herceptin fill efficiency, reduced discrepancies from start to finish and the number of rejected vials. Met deadlines to release Herceptin to the U.S. market. o LIMS Labware: Work with multiple support groups to revise Labware SOP so that sample input is easier and more efficient. Show less