• Manage a staff of 16 Associate Specialists, Specialists, Senior Specialists, and Managers.• Manage day to day operation of five separate Quality Operations Microbiology and Environmental Monitoring laboratories responsible for routine environmental monitoring, sterility, neomycin potency, bioburden, water, endotoxin, biological indicator, process simulation, total organic carbon, conductivity, pH, nitrate, osmolality, freezing point, and media qualification testing.• Business reviewer and approver for laboratory investigations, 8-step problem solving, CAPAs, change controls, and equipment I/O/PQ, QAP, and CS documents.• Site microbiological QMS topic owner. • Subject matter expert and tour lead for internal Quality and regulatory audits/inspections.• Represent Quality Operations Microbiology in site Hoshin Kanri events and lead resulting actions.• Review and approve method suitability test protocols and reports.• Perform data review and authorization of GLIMS batches for in-process and finished product samples.• Lead daily Tier 1, Tier 2, and Tier 4 Quality Operations meetings. Present weekly laboratory operations metrics.• Lead site objective for the implementation of sterility, endotoxin, and bioburden testing for three new candidate vaccine products, associated in-process materials, and raw materials.• Responsible for authoring and presenting laboratory project A3 and glidepath slides to site Quality Council and Steering Committees.• Responsible for the interviewing, onboarding, and training of new Quality Operations Microbiology employees and ensuring continued up-to-date training of all current Quality Operations Microbiology employees. • Laboratory lead and sponsor for the installation and implementation of capital equipment including SKAN sterility testing isolators and Bruker MALDI-TOF Biotyper.• Laboratory lead for the integration of testing of Gardasil, BCG, and Johnson and Johnson COVID-19 vaccines into the Merck Durham facility.

• Managed a staff of 12 comprised of Associate Specialists, Specialists, and Senior Specialists.• Managed day to day operation of four separate Quality Operations Microbiology and Environmental Monitoring laboratories responsible for routine sterility, neomycin potency, bioburden, water, endotoxin, biological indicator, and media qualification testing.• Subject matter expert and tour lead for internal Quality and regulatory audits/inspections. • Authored, reviewed, and approved method feasibility and method suitability test protocols and final reports.• Performed data review and authorization of GLIMS batches for in-process and finished product samples.• Led daily Tier 1, Tier 2, and Tier 4 Quality Operations meetings. Presented weekly laboratory operations metrics.• Led site objective for the implementation of sterility, endotoxin, and bioburden testing for three new candidate vaccine products, associated in-process materials, and raw materials.• Responsible for authoring and presenting laboratory project A3 and glidepath slides to site Quality Council and Steering Committees.• Responsible for the interviewing, onboarding, and training of new Quality Operations Microbiology employees and ensuring continued up-to-date training of all current Quality Operations Microbiology employees. • Laboratory lead and sponsor for the installation and implementation of capital equipment including SKAN sterility testing isolators and Bruker MALDI-TOF Biotyper.• Laboratory lead for the integration of microbiological testing of Gardasil, BCG, and Johnson and Johnson COVID-19 vaccines into the Merck Durham facility.

• Oversee the execution of the Environmental Monitoring Program.• Review all data and results associated with the Environmental Monitoring Program.• Execute and maintain the gowning certification program for all Bioprocessing operators.• Investigate all out of trend, alert, and action level results obtained through the Environmental Monitoring Program.• Develop and implement corrective and preventive actions as necessary through the non-conformance management program.• Author, review and approve Standard Operating Procedures, protocols, and reports associated with the QC Microbiology and Environmental Monitoring Programs.• Procure the required equipment and instruments necessary for start-up and continued operation of the QC Microbiology laboratory.• Author user requirement specification documents and operational procedures for equipment and instruments purchased for the QC Microbiology laboratory.• Oversee the development of essential QC Microbiology core laboratory functions, including biological indicator, endotoxin, bioburden, and sterility procedures, as well as media qualification and release.• Represent the QC Microbiology laboratory during regulatory inspections, internal and external partner audits.• Responsible for the on-boarding and training of new QC microbiology employees and ensuring continued up-to-date training of all current QC Microbiology employees.• Support off-site auditing of third party vendors/laboratories providing services to the QC Microbiology program.

• Managed the day to day operation of the Quality Control Methods Development & Validation (QCMD&V) Microbiology group.• Scheduled all testing associated with the development, validation or suitability of raw materials, intermediates and finished products.• Authored method development, validation and suitability protocols in addition to final reports.• Executed method development, validation and suitability (sterility, bioburden and endotoxin) as required for new products and products transferred from other Grifols sites.• Authored Test Method Master Implementation plans for the QCMD&V Microbiology, Biochemistry and Chemistry groups.• Served as the subject matter expert for the QCMD&V Microbiology group.• Performed routine monthly audits of all QCMD&V groups to ensure continued compliance and audit readiness.• Served as the site safety representative for all QCMD&V groups and lead the monthly QCMD&V safety meetings.• Developed and implemented a 5S plan for the QCMD&V Microbiology laboratory. Currently developing 5S plans for the remaining QCMD&V laboratories and release testing groups.• Developed the QCMD&V user and laboratory requirements for the pending move into a new facility.

• Manage day to day operation of the Microbiology laboratory.• Supervise a staff of 10 scientists• Serve as a subject matter expert for internal, client and regulatory audits/inspections.• Author and revise test protocols, methods and standard operating procedures.• Perform routine client microbiological testing to assure all internal and external deadlines are met.• Perform routine audits of the microbiology laboratory to ensure a constant state of readiness and compliance.• Author laboratory investigations and problem reports.• Serve as the primary Project Director for the QC Microbiology department.• Train and mentor junior staff on various test methods, techniques and good laboratory/documentation practices.

• Manage day to day operation of the Microbiology laboratory.• Supervise a staff of 10 scientists• Serve as a subject matter expert for internal, client and regulatory audits/inspections.• Author and revise test protocols, methods and standard operating procedures.• Perform routine client microbiological testing to assure all internal and external deadlines are met.• Perform routine audits of the microbiology laboratory to ensure a constant state of readiness and compliance.• Author laboratory investigations and problem reports.• Train and mentor junior staff on various test methods, techniques and good laboratory/documentation practices.

• Manage day to day operation of the Microbiology laboratory.• Supervise a staff of 10 scientists• Serve as a subject matter expert for internal, client and regulatory audits/inspections.• Author and revise test protocols, methods and standard operating procedures.• Perform routine client microbiological testing to assure all internal and external deadlines are met.• Perform routine audits of the microbiology laboratory to ensure a constant state of readiness and compliance.• Author laboratory investigations and problem reports.• Train and mentor junior staff on various test methods, techniques and good laboratory/documentation practices.

• Serve as a subject matter expert for internal, client and regulatory audits/inspections.• Author and revise test protocols, methods and standard operating procedures.• Perform routine client microbiological testing to assure all internal and external deadlines are met.• Perform routine audits of the microbiology laboratory to ensure a constant state of readiness and compliance.• Author laboratory investigations and problem reports.• Train and mentor junior staff on various test methods, techniques and good laboratory/documentation practices.

• Executed the Environmental and Water Monitoring programs for the Wilson, NC facility.• Authored and executed protocols for the method validation of Microbial Limits Testing for all raw materials used in the production of Purdue Pharma finished products.• Served as the subject matter expert for internal, 3rd party and regulatory audits/inspections.• Authored and executed all microbiology laboratory investigations.• Represented Quality Control Microbiology in all interdepartmental projects.

• Primary duties included performing all VITEK 2 microbiological identifications and biochemical testing on all isolates recovered from finished products, raw materials and environmental monitoring.• Actively trained manufacturing and packaging personnel in gowning, aseptic sampling, hygiene and basic microbiology.• Performed audits of production master cleaning procedures and manufacturing practices to minimize and identify potential microbial contamination.