Summary of Qualifications
Over 17 years of experience in the biotech field in both quality and development organizations. Experienced with FDA regulations on current good manufacturing/laboratory practices (cGMP/cGLP), and corporate compliance in quality control environment. Have strong analytical method development and validation skills. Work independently and have a strong attention to detail. • As a Validation Manager and part-time QC Technical Manager; I am able to apply my project management skills to oversee validation activities, implement the control system by authoring, reviewing and approving validation protocol/reports; creating product specification documents, sampling plans and test procedures for assigned projects. • A key player to identify, evaluate, and implement continuous business process improvements. • Partner with project leaders and team members to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle across Genentech’s clinical product portfolio and contract manufacturing sites. • Train personnel and internal customers on relevant business processes.
• Arranger – enjoy managing multiple variables/factors in projects to ensure goals are met. • Learner – self-motivator and eager to learn new processes and strategies to implement within the department/organization. • Developer – enjoy training personnel and internal customers on relevant business processes. Have served as a peer advisor to multiple people on various activities, such as, ADQC mentor, being a resource for GMP guidelines and analytical methods.
• Experienced in performing various analytical methods in both GMP and non-GMP environments. • Very proficient in CE-SDS, SDS-PAGE, SEC, IEC, ICIEF, RP-HPLC, UPLC, FPLC, Bioanalyzer, FFE (Free Flow Electrophoresis), Rotofor, UV Spectrophotometer, Plate reader assays, Osmolality • Independently design and develop protocols (training and experimental) experiments, and reports. • Various computer skills and software: Microsoft Word, Excel, OneNote, MS Project, PowerPoint, Smartsheets, JMP, LabManager (LIMS), Empower, Trackwise (Discrepancies and CAPAs), WebEx, gTalk, ProteinSimple software, and IDBS EWorkbook/BioBook