• Serve as primary liaison between client and vendor teams and Covance assigned project team.• Effectively manage a large portfolio of complex clinical trial studies (Phase I – IV) with individual budgets up to $6 million. Total portfolio of managed studies exceeds $40 million.• Review final clinical protocols to identify client objectives and needs and create solutions to implement best in class study design.• Work closely with the client study teams to draft and finalize scope of work documents, study budgets, and study timelines. • Continuously review study design and study activities to assess and identify risk and then provide customized solutions to mitigate those risks.• Manage project related activities that include working with the client, participating investigator sites, and internal Covance team members to resolve queries, reconcile clinical data, manage internal resources to ensure timely delivery of data• Deliver customized reports and monitoring services to the client to ensure all study milestones are met on time and within the established study budget.• Therapeutic experience includes Infectious Disease and Oncology indications.

• Served as the site wide Manufacturing and Packaging Cleaning Validation program owner and Subject Matter Expert (SME). • Managed the site wide Cleaning Validation Program Technical Agenda.• Developed and implemented the cleaning validation program for new Lilly Clinical Trial products as they entered commercial Manufacturing and Packaging workcenters. This program included optimal cleaning agent determination screening studies, limit of visual detection studies for cleaning agents, APIs and excipients, determination of API and cleaning agent residue swab acceptance limits, and creation and execution of cleaning verification/validation protocols. Quality By Design (QBD) and risk based approach principles were utilized while developing the cleaning program. • Worked closely with Manufacturing Operations Management and Quality Assurance Management to ensure that the cleaning validation program exceeded all Lilly and regulatory (FDA, EMEA, etc) requirements.• Provided global cleaning validation program consulting to other manufacturing sites within Lilly. This included travelling to these sites, performing comprehensive audits of their respective cleaning validation programs, and identifying/implementing solutions to address any program compliance gaps.• Developed and executed a new risk based cleaning bracketing strategy that moved new cleaning processes through the validation process more quickly. Once implemented the strategy led to a reduction in required sampling during validation and a reduction in manufacturing equipment downtime. • Managed multiple cleaning validation project timelines to ensure alignment with manufacturing/packaging schedules and compliance with the Lilly GMP plan objectives. • Authored the Cleaning Validation Master Plan and Cleaning Validation Program Annual Report documents.• Authored multiple protocols, technical reports, and risk assessment documents.

• Developed extensive technical expertise with Wet and Dry Granulation, Encapsulation, Tablet Compression, and Tablet Coating equipment and processes all while ensuring a high level of cGMP compliance.• Worked closely with planning and supply chain personnel to ensure a high level of customer service. My efforts played a key role in achieving OSSCE Class A certification and in maintaining shop floor conformance of 100% on time in full (OTIF). • Served as the deviation reduction champion for each manufacturing workcenter that I supported. Utilized Human Error Prevention and Root Cause Analysis principles to reduce operator errors and improve product and documentation quality. My efforts led to a sustained 43% year on year reduction in operational deviations.• Served as the continuous improvement champion for each manufacturing workcenter that I supported. Utilized Lean Six Sigma principles while leading multiple yield improvement and cycle time reduction projects. When combined the projects I completed resulted in an annual savings of $540,000.• Implemented C4I manufacturing process monitoring and capability systems for each manufacturing workcenter that I supported. My efforts led to an increase in equipment reliability and reduction in product quality defects which resulted in an annual savings of $250,000. • Served as the key manufacturing representative in multiple Six Sigma Black Belt projects and Kaizen events.• Served as a manufacturing operations safety champion and led multiple safety and ergonomic related projects. Embraced Incident and Injury-Free (IIF) principles while leading these projects.

• Managed a team of analysts by scheduling and coordinating group workload and managing personal career development.• Served as primary laboratory contact for new analytical method transfers in support of clinical trial operations.• Served as a key member of the laboratory safety and compliance teams.• Served as a primary leader in laboratory investigational activities.• Authored multiple analytical method transfer protocols and laboratory SOPs. • Served as a subject matter expert on good documentation practices, laboratory deviation reduction, analytical method validations and transfers, local SOPs, and equipment.• Provided analytical support for new product manufacturing process validation. • Performed analytical assays using instrumentation such as Dissolution Apparatus, HPLC, FTIR, UV/Vis, Karl Fischer, and wet chemistry techniques.• Trained fellow analysts on new methodology that was transferred from Lilly analytical development laboratories.