Validation Manager for a GMP Gene Therapy / Cell Therapy production facilityManaged a team of three validation engineers supporting all qualification activities for the AGC Longmont Cell and Gene Therapy Manufacturing Site. Scheduled and coordinated validation staff as well as staff from Manufacturing and Quality to complete execution of validation projects. Lead project meetings to ensure adherence to the schedule. Generated Smartsheet tools to track and report validation document generation and execution progress and adherence to AGC KPIs. Developed new KPI’s to track validation program adherence to quality standards. Presented to auditors in internal and client audits. Authored audit responses and defined strategy to address gaps identified in audits. Initiated operational excellence (OE) improvements including projects to update validation protocol templates to ensure consistency.

Senior Validation Engineer for a GMP Gene Therapy / Cell Therapy production facilityReviewed, approved, and authored validation qualification protocols and reports for a variety of QC, Utility, and Manufacturing systems including Empower CDS, HPLCs, Plate readers, Capillary Electrophoresis, Closed Container Integrity Testing (CCIT), quantitative PCR, digital droplet PCR, and BacT Rapid Bacterial IDTrained and mentored junior QC and validation staffImplemented data integrity improvements to the equipment onboarding and qualification process including creating a more robust data integrity assessment included in the validation processManaged the QC equipment qualification schedule of over 100 instruments. Coordinated QC, IT, and contract staff to complete qualification executionManaged quality records including change controls, deviations, and CAPAsPresented equipment validation program documents, protocols, and reports in internal and client audits

Validation Engineer for a start-up GMP gene therapy production facilityQualified QC systems from simple instruments such as balances and pH meters to computerized instruments such as HPLCs or Mass Spectrometer systems Qualified site utility systems including the plant Water for Injection (WFI) system and the QC lab water system Authored, reviewed, and approved validation protocols and reportsPerformed data integrity risk assessments on computerized equipment systems and implemented identified mitigations to ensure system data integrity Assessed the impact to proposed changes to validated systems in system change control assessments Presented equipment validation program documents in internal quality audits

Senior Laboratory Equipment Owner for all Quality lab equipment at start-up GMP biopharmaceutical production facilityResponsible for installation and validation of Quality analytical instruments including individual system configuration to meet analytical method requirementsAuthored, reviewed, and approved validation qualification protocols and reports for equipment systemsDeveloped maintenance programs and defined maintenance requirements for QC analytical equipmentAssessed data integrity on Qualty analytical equipment systems, identifying gaps in data integrity standards and mitigating data integrity risksApplied lean management principles defining standard work, Practical Problem Solving and Level Zero analysis, improving processes while troubleshooting challenges

Quality Control Analytical Equipment System OwnerLaboratory equipment manager for QC Microbiology and Bioanalytical Science groups in a Good Manufacturing Practice (GMP) environment supplying commercial pharmaceutical products• Ensure QC Systems equipment is in compliance to FDA-enforced GMP as well as other domestic and international regulations and standards• Identify and implement equipment system process improvements and upgrades coordinating with internal cross-functional groups and outside vendors• Monitor and delegate routine maintenance work order completion ensuring GMP documentation compliance as well as initiating equipment failure investigations• Investigate and problem solve equipment failures to resolution both independently as well as in collaboration with outside vendors to complete corrective maintenance• Review and execute validation documents for new equipment and upgrades to existing equipment• Examine key quality metrics and indicators to track conformance and compliance. Analyze data to execute action plans to standardize, streamline and improve processes and procedures • Author SOP (Standard Operating Procedures) and GMP documents governing the maintenance and use of laboratory equipment• Establish and maintain successful cross-functional relationships with other Amgen domestic and international sites to implement QC equipment systems often traveling to complete onsite system set up, compliance, training, and problem-solving• Identify and analyze next generation QC laboratory systems as well as what is required to validate and implement these systems into QC• Present to domestic and international regulatory agencies that system compliance and regulations have been met for the United States FDA, European Medicines Agency (EMA), Health Canada, Ministry of Health (Mexico) and Ministry of Health (Turkey)

Lead analyst that performed various bioassays including cell proliferation, cell survival, and reporter gene. Executed release and stability testing for potency for commercial drugs and analyzed and interpreted data results• Successfully lead project for the QC Bioanalytical laboratory to implement and qualify the TECAN Automated Liquid Handler that is programmed to perform bioassay and ELISA methods. Invalid samples and assays as well as out of specification investigations were markedly reduced establishing the TECAN automated system as the new standard• Developed GMP qualification testing of automated assays• Spearheaded SOPs, maintenance job plans and documents governing the TECAN• Developed and authored TECAN training plan and responsible to train personnel on automation technology• Represented Bioassay Team for build-out of new Cell Biology laboratory• Participated in written responses to regulatory agency inquiries

Managed day-to-day activities of a start-up biotechnology company. Participated in research on therapeutics for the prevention of immunological transplantation rejection

Administrative manager for immunology research laboratory as well as performed research on engineering anti-viral DNA vaccines on own initiative