Melissa Heckart, MS, PMP

- Leading team of analysts responsible for managing on-time clinical drug supply - Working with matrix teams to implement process improvements for streamlined communications and clearer understanding of lead times - Mentoring junior team members in career development and project management best practices to achieve improved outcomes

- CMC Program Manager for development programs leading matrix teams from IND submission prep through commercialization - Working with fast-paced drug development to successfully commercialize cornerstone oncology program via breakthrough designation - Supporting the CMC aspects for post-commercialization programs in combination with Strategic Alliance partners - Collaborating with business development partners to achieve mutually beneficial end results

Centralized coordination of clinical trial bulk drug product. Matrix team management comprised of manufacturing, analytical, and drug supply personnel both locally and globally. Project leader for implementation of new inventory system for drug product pilot plant. - Oversight for preparation of manufacturing, testing, and release for as many as 100+ batches of 14 projects per year. Included scheduling activities for rooms, equipment, and material availability. - Pilot Plant Site Process Lead for successful and on-time year-long SAP inventory system implementation. Drove for completion of different aspects of implementation including complete replacement of current inventory system, transition from paper batch records to electronic documentation. Remains only full R&D site to do so. - Collected and compiled quarterly metric reports. Evaluated necessity of metrics collected and persuaded upper management support for reducing metric collection by 70% - Maintained forecast and inventories of approximately 100 excipients from both internal and external suppliers. Managed orders and activities required for receipt and release for use. - SharePoint site creator and administrator for communication of batch statuses and excipient needs. Large reduction in email communication and inefficient meeting time. - Clinical Supply manufacturing representation on larger CMC teams. - Created focused discussion points for matrix managed team meetings decreasing average meeting times by 75%

See position details above for position at Abbvie. Abbvie was created as a spinoff of Abbott Laboratories in 2013.

Completion of CAPA documents for identified issues. Oversight of change control documents for department. - Led the completion of Corrective and Preventive Action (CAPA) documents using cross-functional support. - Identified changes to quality procedures and completed change management processes for implementation. Managed periodic review process for 100+ departmental documents. - Created tool for reporting CAPA document statuses especially as they related to aging.

Provided quality support for bulk drug manufacturing. Ensured adherence to company quality system, FDA and EMEA requirements. - Acted as quality representative for as many as six projects at once providing quality review and approval of all batches associated with each. - Assessed and approved third party manufacturer batch records pre- and post-manufacturing - Identified and led process improvement to reduce quality review of third party batch records by over 50%

Manufactured and tested components for clinical diagnostic assays. Provided technical support for product and manufacturing improvements - Provided all aspects of product manufacturing, testing, process improvement and troubleshooting of protein conjugates - Authored numerous change management documents for quality procedures and manufacturing documents - Provided protocol design, execution, data collection, and data analysis for technical support troubleshooting studies

Effects of Conjugated Linoleic Acid on Swine Lipid Metabolism