Amy Santos Email and Phone Number

Responsibilities include all aspects of GXP compliance, including Quality Assurance, Manufacturing Quality, Quality Control Laboratory, DEA, EH&S, Clinical Safety, Clinical Quality and Pharmacovigilance for Aquestive.

Provide leadership, expertise and critical thinking to ensure continuity of product supply and maximum profitability for the business• Functional oversight of planning/scheduling, logistics, warehousing, inventory, EH&S, DEA, purchasing and alliance management across all development stages, Phase I to Commercialization• Oversee all purchasing activities including vendor selection and bidding, order processing, non-conforming material, dispute resolution• Ensure that day-to-day purchasing requirements are executed supporting manufacturing and distribution operations while maintaining desired levels of inventory and minimizing costs • Oversee all day to day shop-floor planning for two facilities• Global vendor management and sourcing for all raw materials, including packaging supplies and Active Pharmaceutical Ingredients (APIs)• Lead direct reports in achieving company goals and strategic planning of resources and budgets• Site leader for commercial operations, responsible for leading, empowering and growing all colleagues • Establish best practices that will achieve organizational goals by managing and optimizing supplier performance• Ensure the establishment of strong strategic relationships with vendors or prospective vendors in order to enhance the performance and reputation of the company and to identify potential new sources of supply for purchased materials

Strategic oversight of critical external relationships and commercial supply of PharmFilm products• Managed supply agreements that generated $30+million in revenue annually• Critical thinking to extract opportunities from contractual boundaries• Managed incoming requests for information from Partners and created workflow around requests to manage fulfillment of requests• Manage financial aspect of contracts to ensure on time billing to meet all milestones• Project managed cross functional teams, both internally and externally, to achieve completion of Partner related milestones, providing feedback look to both Value Delivery and Value Creation• Oversite of all regulatory filings for commercial products, including Annual Reports, CBE-0/30 and PAS • Responsible for oversight of NDA filings, transfers and launches of multi-sku commercial products • On-boarded contracts and Partners, starting with Phase I R&D Development for new projects

Direct and oversee entire Supply Chain function for pharmaceutical manufacturing• Strategic planning for anticipated new products and existing product growth• Developed and maintained Master Schedule to reduce labor costs, improve efficiencies and optimize equipment usage• Directed and controlled cash flow associated with growth of inventory from $3 million to $7 million for just-in-time (JIT) production• Budget development and cost containment for annual raw material budget of $7 million• Managed all vendor relationships, domestic and international, including supply agreements, pricing and deliverables• Sourced and procured all Active Pharmaceutical Ingredients (APIs), both domestically and internationally, for use in new product development • Leveraged technical expertise of vendors to improve quality and reduce waste to ensure delivery of robust product by setting quality and technical expectations while improving relationship with company• Negotiate all material pricing, including APIs to obtain favorable Purchase Price Variance (PPV) and increase Gross Margin % for existing products• Reduced annual spend of packaging components by $400,000 through price negotiations and supply agreement structure• Managed inventory, including controlled substances, and warehousing function and oversee incoming and outgoing shipments to achieve an average On-Time Shipment rate of 92%

Manage Inventory, Purchasing and Warehousing for pharmaceutical manufacturing• Managed offsite warehouse of $1.5 million while planning growth to $3 million• Designed new cGMP compliant warehouse in a newly acquired building for raw material and finished product storage• Coordinated Phase I installation of ERP system for financial and inventory modules• Created and maintain spend against annual raw material budget of $3 million• Developed Master Batch Record for manufacture of pharmaceutical products, including Research & Development, Pilot Clinical, Pivotal Registration, Validation and Commercial products• Strategically sourced and procured all raw materials, supplies and packaging components• Managed vendor relationships for raw materials, supplies and packaging components

Manufacturing of OTC, Nutraceutical and pharmaceutical products in a start up company• Authored compliant Standard Operating Procedures (SOPs) for all equipment in manufacturing area• Developed and implemented first time Quality, Manufacturing and Inventory systems for start up company. Systems included Batch Records, Lot Numbering, Purchasing & Receipt, Inventory Control, Distribution and Manufacturing procedures• Assisted in installation of mixing and coating equipment• Performed all in-process and analytical testing