Angela Pishioneri

As a Regulatory Associate II, strategize on both commercial and development project teams, perform quality control on regulatory documents, and assemble for submission. • Organize, analyze, and evaluate CMC regulatory documentation for commercial and development products for both the US and ex-US • Develop project timelines to support regulatory filings to meet the required filing dates • Serve as the liaison between the contract manufacturer and license holder so that change requests are filed appropriately in the respective countries • Supporting a cross-functional team to get a US clinical manufacturing site ready for GMP inspection and be approved by a European regulatory agency • Compose CMC CTD sections for US filings • Review submission documents from a CMC perspective • Provided support for an FDA inspection by supplying requested regulatory filings

As a Pilot Production Technician III, trained individuals in the purification procedures and reviewed Master Production records to ensure completion and that all SOPs and GMPs were followed. • Trained others in the group till proficiency in all process steps of purification • Worked independently to ensure all equipment and production materials for manufacturing were available • Subject Matter Expert in nanofiltration and bulk filtration

As a Pilot Production Technician II, created and implemented purification procedures, managed team of 8 technicians, ran the day-to-day administrative responsibilities of the team in conjunction with following the regulations of government policy and ordinance. • Developed standard operating procedures in compliance with current practices and conducted review of batch records • Formulated and oversaw the purification process procedures for the production of clinical drug products • Conducted training seminars for nanofiltration, bulk filling procedures, and CIP/SIP/Pressure hold of fixed tanks • Managed and coordinated lab technician’s schedule, materials, and ensured that guidelines were met • Established new laboratory suite for microbial clinical products by designing layout, ordering products, and updated billing requirements • Executed quality checks and conducted tests for fixed tank-to-tank transfer studies, fixed tank circuits, and established sampling limits on fixed tanks • Implemented new strategies for new procedure for nanofiltration (for large product volumes) • Using Rockwell Automation Software wrote recipes for CIP/SIP/Pressure hold of fixed tanks

MedImmune focuses mainly on cancer, asthma, and lupus. As a Pilot Production Technician I, developed clinical drug product processes and produced several clinical drugs. • Restructured training curriculum for the team • Assisted senior level project leads to improve process conduct • Expert in cGMP and GDP procedures to align with government regulations.

To ensure the proper preparation of buffer solutions, as a contractor, worked to enhance knowledge of the purification procedures in the industry. • Weigh-outs of necessary raw materials for preparation of buffer solutions • Preparation of buffer solutions from bench top to large-scale volumes • Received “Director’s Award” for satisfying clinical drug deadlines

As the Lab Intern, worked independently in the lab and provided support for a drug filling environmental investigation. Increased efficiency by 66%, completing the project in one month span. • Using Excel, to sort, formulate, and organize materials needed by the microbiology and sterility labs • Utilized database for request forms, standing orders, and handling accounts receivables • Using VITEK software, performed bacterial identification procedures and tests