Jessica D.

• Created a database that chronicles all API change notices and amendments that Sagent has received from API vendors. • Structured the process workflow of API change notifications in TrackWise. • Provided support to product development and commercial projects at various Sagent sites. • Worked closely with API suppliers on pricing, incoterms, technical documents, and other business-oriented transactions. • Established a Sagent-owned Raw Material Supplier Specification system for Sagent for use in supplying a specification to our API suppliers; representative of the API Sagent procured.

• Consulted with companies to provide expertise in the areas of pharmaceutical API and drug development and manufacturing, project and program management, CMO agreements and various technical, packaging and supply chain projects.

• Executed program management comprised of managing an integrated functional project plan, publishing executive-level performance dashboard, and organizing monthly reviews with C-suite and functional leads to ensure timely product launches. • Established Prometic’s U.S. state licensing portfolio required to legally distributed drugs in more than 30 states. • Facilitated and managed the implementation of a serialization and track & trace network solution between CMO, Prometic and Third-Party Logistics Provider (3PL) as required by the Drug Supply Chain Security Act (DSCSA). • Facilitated and managed the implementation of 3PL capabilities (i.e. warehousing, shipping, transportation and back office) required to establish Prometic’s U.S. commercial supply chain. • Established a working model of Prometic’s Finished Product Inventory Management System to minimize shortages and expired product.

• Built and maintained the foundation for continuous improvement by ensuring the effective functioning of transformation activities in manufacturing, operations and supply chain. • Ensured site compliance to all labor, safety, and environmental regulations, drove step change in safety performance and monitored new/emerging regulatory requirements for sterile manufacturing. • Engaged CMOs as the primary contact to resolve business and technical issues efficiently and cooperatively. • Collaborated with Quality to review batch records, deviation reports, risk assessments, CAPA’s, and ensured CMOs complied with cGMPs and Quality Agreements. • Spearheaded parenteral drug product technology programs, which included: formulation development, process optimization, component sourcing and qualification, and technical transfer to an alternate CMO.

• Reviewed product specific validations, materials, suppliers and other regulatory compliance gaps, and prepared summaries, conclusions and remediation steps. • Prepared executive summaries of each product specific review conducted; managed and controlled the documentation related to the reviews. • Identified, designed and implemented quality, safety, throughput and ergonomic improvements into all manufacturing work. • Provided international support to company site in India in assessing and aligning site procedures to corporate procedures and assisting in pre-approval readiness.

• Prepared master batch records and protocols for the manufacture of development, stability, and validation batches, and translated development findings into manufacturing processes. • Performed internal audits to check for the robustness of the quality management system and confirm whether it is in accordance to ISO 9000 standards. • Initiated Risk Assessments and evaluated continuous product verification (per FDA guidance) on the products that have established a batch history to check for product consistency, stability and a state of control per FDA guidance. • Developed, investigated and implemented changes that improved Overall Equipment Effectiveness (OEE) performance, and served as the plant liaison for channeling all manufacturing-related questions and issues for resolution. • Accurately and completely recorded experimental procedures, test results, and observations to meet Regulatory and FDA (21 CFR Part 11) cGMP requirements.

Analyzing, visualizing and working with data using R.