• Increased revenue of 25-employee lab from $6M to over $10M through various Lean Six Sigma continuous improvement efforts and managed multiple projects to meet customer requirements• Worked with customers (300+) to develop solutions to overcome challenges and create strategies using complex analytical data• Collaborated with the Business team to identify and capitalize on new revenue streams and opportunities that matched laboratory capabilities, resulting in over 60% Gross Margin for two consecutive years• Conducted in-depth analysis of laboratory capabilities to support the negotiations of multi-year, multi-million dollar contracts with clients• Directed transversal projects with internal groups worldwide to expand lab capabilities and grow the P&L of the organization with 5+ year timelines• Directed multiple labs at other national locations to support growth and profitability

• Directed and managed laboratory operations, prioritizing the utmost safety and data quality assurance in all processes• Ensured the ISO compliance, both 9001 and 17025, was maintained for all sites• Served as the main contact point and SME for technical issues and quality issues for all customers, including CAPAs, 5-WHYs, 8Ds and FMEA analysis• Won Supplier Recognition Award from Texas Instruments, out of 2,000+ suppliers, for being a Voice of the Customer and meeting all quality and reliance challenges

• Developed and implemented Key Performance Indicators for all lab activities, such as growth metrics, BCP, turnaround time, and Quality Event closure• Elevated the competencies and expertise of scientific and laboratory personnel, cultivating their development into more proficient and valuable team members• Prepared FDA CMC sections and technical documentation for ANDA and NDA submissions for multiple sections including 3.2.P.2 Pharmaceutical Development• Served as a member of the company Executive Leadership Team to develop the core business strategies for the company• Developed an R&D analytical group for a new $50M Revenue company, including processes, SOPs and hiring of employees to facilitate the manufacture of OTC drugs

• Developed Analytical Methods for low level impurities and assays in drug products using LC/MS/MS and UV HPLC systems• Performed root cause drug product development investigations to determine stability profiles and drug product characteristics

• Project lead on multiple projects and project teams throughout development of FDA CMC Drug Product life-cycle• Understanding of Drug Product, Excipient, and API physicochemical properties and how they relate to final Drug Product stability• Analyze and report on complex scientific and regulatory documentation performed on drug products to Executive Team

• Development of initial analytical testing for materials and products within the early stages of product development, including enantiomer assays and derivative assays.• Assist in the development and experimentation of pharmaceutical products for FDA submittal such as ANDAs and NDAs.• Manage projects and time for R&D technicians during the creation of various ongoing projects.• In depth analysis of particle size using laser diffraction to characterize and understand new R&D formulations and Drug Products.• Analyze and report on complex scientific and regulatory documentation performed on drug products to upper management, such as In-Vivo In-Vitro correlations and crystalline polymorphic forms of materials and their relation to bio-availability and dissolution rate.• Writing and editing SOP documents, development reports, and experimental data.