• Strong technical capabilities and experience in new product development, regulatory filing, process and formulation development, method validation, technology transfer, quality control, stability testing, analytical investigations, new technology implementation, cGMP manufacturing support, and project management;

  • Management experience of teams, laboratories, and project management, leading large group (30+) of senior chemists and microbiologists in Tippecanoe QC Laboratories supporting new product validation and launches, production batch release, deviation investigation, method remediation, validation and tech transfers from R&D;

  • Extensive experience in establishing strategies and leading teams to successfully complete a large number (200+) of analytical method remediation, validation and tech transfer projects in Tippecanoe Laboratories;

  • Strong project leadership skills and experience, especially capable in leading complex projects involving cross-functional and external partners, very familiar with project management tools and techniques. Recent examples include new Alimta process development and successful registration; multiple Tylosin manufacturing process transfers involving tech service, QA/QC, global supply chain, procurement, finance, global regulatory submissions and external partners; Leadership experience in establishing specification governance process involving cross-functional groups and stakeholders (R&D, Regulatory, manufacturing, quality and statistics);

  • Numerous IND/NDA filings and successful regulatory inspections (US FDA, EMA, Japan PMDA, Korea FDA, Chinese cFDA);

  • CRO/CMO vendor evaluation, selection, auditing, and oversight (technical capability, quality, financial, capacity, supply chain, management team, culture, and customer service); Due diligence for in-licensing molecules (pre- and post-commercialization);

  • Authored and reviewed over 900 drug development and quality documents; Published over 30 peer-reviewed papers, patents, and book chapters;

  • Balanced in technical expertise and leadership skills; Ability to establish and maintain close relationship with partners/clients for optimal business results; Inspiring, motivating and mentoring team members;

  • Excellent presentation and communication skills;

  • Cross-cultural communication skills;

  • Strong organizational skills.