Provided quality oversight, review and management for quality systems such as, but not limited to change management, vendor and customer/product complaints, deviations, CAPAs, training and OOS/OOT investigations.Provided knowledgeable understanding of the chemistry, biologics, and microbiological principles associated with a biopharmaceutical manufacturing environment as well as plant utilities services such as compressed process air, clean steam, and Water-for-Injection (WFI) to… Show more Provided quality oversight, review and management for quality systems such as, but not limited to change management, vendor and customer/product complaints, deviations, CAPAs, training and OOS/OOT investigations.Provided knowledgeable understanding of the chemistry, biologics, and microbiological principles associated with a biopharmaceutical manufacturing environment as well as plant utilities services such as compressed process air, clean steam, and Water-for-Injection (WFI) to support function groups.Provide in Plant Quality support and critical decision making for biological drug substance manufacturing activities.Reviewed / approved QC Analytical Testing, Stability Data and Certificates of Analysis; Validation Protocols and Study Reports.Reviewed / approved both Clinical and Commercial Master Batch Records (MBRs) and Executed Production Batch Records (EPBRs).Implemented and maintained document lifecycle, including but not limited to SOP authorship/writing, SOP review/approval and training.Reviewed Study Reports for inclusion in CMC regulatory submissions (IND / IMPD / BLA).Participated in FMEA Risk Assessments.Reviewed / approved cleaning validation documents for equipment, methods and processes.Approved Bulk Drug Substance (BDS) and Antibody Drug Intermediate (ADIs) shipments. Show less

Ensured compliance with applicable regulatory and industry standards, implemented quality improvements, and optimized processes for phase-appropriate GMP manufacture of biological products. Served as the liaison between QC, clients, and internal customers. Communicated and coordinated work status with quality leadership.Provided overarching support across the QC team for late stage clinical and commercial programs.Qualified trainer and qualified investigator responsible… Show more Ensured compliance with applicable regulatory and industry standards, implemented quality improvements, and optimized processes for phase-appropriate GMP manufacture of biological products. Served as the liaison between QC, clients, and internal customers. Communicated and coordinated work status with quality leadership.Provided overarching support across the QC team for late stage clinical and commercial programs.Qualified trainer and qualified investigator responsible for determining path forward for quality records and managing cross-functional teams to ensure timely completion and appropriate corrective and preventive actions. Planned, designed, and executed complex and technically demanding projects while working with internal staff and external experts. Met project goals within time and budget constraints.Performed cGMP compliant onboarding, qualification and lifecycle management of lab instrumentation and systems.Initiated, implemented, planned, directed, and executed deviations and investigations to resolve events, understand trends and improve process performance.Facilitated and reviewed deviations, laboratory investigations, change controls, CAPA commitments, effectiveness checks, including initiation, tracking, trending, and closure.Planned and executed continuous quality improvements in the QC laboratory.Worked with QC lab management to maintain an audit ready status. Acted as QC SME for areas of responsibility during client and regulatory audits/inspections.Ensured compliance by using comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP, EP, JP and other applicable regulations and guidance. Show less

Led the QC microbiology team in a supervisory capacity, performed upper level tasks while focusing on improving task ownership and interdepartmental communication and collaborationPerformed Analytical testing on finished product, raw materials, API, and in-process materialsPerformed product Dissolution testing and physical sample inspections Performed investigational testing in the Analytical and Microbiology laboratoriesIdentified aberrant data/excursions and… Show more Led the QC microbiology team in a supervisory capacity, performed upper level tasks while focusing on improving task ownership and interdepartmental communication and collaborationPerformed Analytical testing on finished product, raw materials, API, and in-process materialsPerformed product Dissolution testing and physical sample inspections Performed investigational testing in the Analytical and Microbiology laboratoriesIdentified aberrant data/excursions and organized and conducted thorough investigations resulting in risk assessment and implementation of CAPAs and awareness communicationsImplemented Standard Operating Procedures in the Analytical and Microbiology laboratoriesAuthored and Revised SOPs and coordinated implementation of new instruments and equipmentIndependently revised, clarified, and improved the environmental monitoring program using USP, ICH, EP, and other guidance documents to improve analyst training, test execution, and trendingExperienced with software and instrument validation for use in the Quality Control laboratoriesCoordinated sample shipment and testing with Contract LaboratoriesServed as SME and primary trainer for the Environmental Monitoring program and related activitiesServed as SME and primary trainer for product dissolution testing (similar to apparatus IV)Planned, coordinated, and executed various projects and environmental monitoring supportExperienced with growth promotion, Gram stain, Biological Indicator testing, and environmental monitoring testing using viable air samplers, non-viable air samplers, contact plates, TSB, and settle platesOrdered and maintained laboratory supplies and coordinated instrument calibration with the Metrology groupConducted, documented, and reviewed laboratory work in accordance with cGMPs, SOPs, and Test MethodsAuthored and compiled formal reports including quarterly result trending, PQR, deviations, and investigations Show less

Offered reliable and trustworthy execution of managerial tasks through teamwork and multitasking while instructing and training employees. Routinely managed direct reports on a shift-by-shift basisOperated as an effective addition to the managerial staff via offering a unique perspective on employee management. Knowledge and determination allowed for promotion in less than seven months.Personally facilitate proper food handling techniques, control methods, and safety measures… Show more Offered reliable and trustworthy execution of managerial tasks through teamwork and multitasking while instructing and training employees. Routinely managed direct reports on a shift-by-shift basisOperated as an effective addition to the managerial staff via offering a unique perspective on employee management. Knowledge and determination allowed for promotion in less than seven months.Personally facilitate proper food handling techniques, control methods, and safety measures to ensure all company and federal guidelines are upheld Show less

Explored the structure and dynamics of ceramide channels in simulated cell membranes through applying varying voltages in order to better understand effects on cell functionConstructed an in-solution phospholipid bilayer under microscope in order to insert the BAX protein or protein mutant and simulate cell functionApplied varying voltages to determine orientation of 3-constituent channels and their effects on the membrane and each otherUpheld a high standard of precise… Show more Explored the structure and dynamics of ceramide channels in simulated cell membranes through applying varying voltages in order to better understand effects on cell functionConstructed an in-solution phospholipid bilayer under microscope in order to insert the BAX protein or protein mutant and simulate cell functionApplied varying voltages to determine orientation of 3-constituent channels and their effects on the membrane and each otherUpheld a high standard of precise data capture methodology and analysisPrepared chemical reagents using quantitative transfer and aseptic techniquesExperimented using oscilloscopes, electrodes, wave generators, and other types of monitoring equipment and software in a laboratory environment Show less

Managed direct reports on a shift-by-shift basis daily for six yearsOffered well developed skillset in a team-oriented environment in order to assist coworkers in the fluidity of the workplace. Detail-oriented knowledge provided an essential asset to colleaguesDeveloped a detailed understanding of the importance of microbiology in food safetyInstructed and advised all coworkers in order to ensure the highest standards were upheld