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Ph.D. Chemical and Biopharmaceutical Import and Trade Compliance Expert

Technical Consultant #2584


Expertise

  • Chemical and biopharmaceutical product import classifications for the global Harmonized Schedule (HS) and the Harmonized Tariff Schedule of the United States (HTSUS).
  • Export control regulatory compliance of the U.S. Department of Commerce, Bureau of Industry and Security (BIS).
  • Export classifications to give Schedule B and Export Control Classification Numbers (ECCN)
  • Customs (CBP) import regulatory compliance for partner government agencies such as FDA, USDA, and FWS.
  • Regulatory compliance with economic sanctions regulations of the United States (OFAC), EU and UK, particularly as they pertain to life science companies.
  • Compliance program development including authoring and implementation of R&D technology control plans for U.S. export-controlled biopharmaceutical agents.
  • Implementation of automated restricted party screening system.
  • Analysis of the applicability of, and development of a compliance framework for, extra-jurisdictional aspects of the U.S. OFAC regulations including those targeting Iran, Syria, Russia, and Venezuela.
  • Obtaining U.S. Department of Commerce (DOC) licensing for U.S.-manufactured pharmaceuticals and associated technology to Cuba.
  • Small-molecule drug project technical membership, project management, and leadership experience for Lead Identification and Lead Optimization R&D phases.
  • Functional knowledge of corporate compliance regulatory areas for trade compliance, bribery and corruption, controlled substance legislation, and third-party risk management.
  • Cross-functional working within multinational pharmaceutical companies spanning R&D through delivery and commercialization.
  • Compliance framework design and implementation to Prevent, Detect, and Respond to compliance issues.
  • Corporate compliance officer for pharmaceutical manufacturing and supply sites in the Americas and Europe.
  • Multinational experience supporting business associates throughout the Americas, Europe, Russia, and the Middle East.

Experience

U.C.C., LLC, Principal. 2019 - Present

  • Offering consulting services with a focus on the chemical and life science industries in the areas of import and export classifications and resultant regulatory requirements including those of Partner Government Agencies.
  • Offering compliance consulting services for export control regulations and development, assessment, or enhancement of frameworks for trade compliance and other corporate compliance risk areas across industry sectors.
  • Enhanced and supported the trade compliance program for Customs, USDA, and other Partner Government Agencies for the key program of a rapidly growing clinical stage biopharmaceutical company.
  • Supported classification and licensing for exports of drones and drone accessories for a custom UAV manufacturer.
  • Determined import classifications (HTSUS) for an agricultural company.
  • Performed analysis of risks related to import regulations of partner government agencies for several industry sectors for an eCommerce company.

AstraZeneca Pharmaceuticals, Wilmington, DE, 1998 - 2019

Associate Director Global Export Controls and Sanctions Compliance, 2013 - 2019

  • Developed and implemented a global, enterprise-wide export controls and sanctions compliance framework which included being the primary point of contact for all areas of the business to provide specialized subject matter expertise, training, and compliance oversight.
  • Defined the company's compliance risk profile for export controls and economic sanctions by analyzing the company's activities from research through commercialization and determining where the regulations applied.
  • Developed and led a global network of individuals across functions (e.g., Legal, HR, Commercial, Supply Chain, Regulatory Affairs, Group Finance, Business Development, IT) that were accountable to implement appropriate controls to provide assurance for compliance with export controls and sanctions regulations.
  • Developed and delivered targeted training via eLearning, bespoke presentations, and 1:1 conversation.
  • Supported projects through research, development and into clinical trials by leading discussions to understand the licensing and other requirements for U.S. BIS compliance for non-EAR99 research, investigational materials, and associated technology.
  • Led the development and implementation of the Technology Control Plan for a project involving multiple functional areas which included physical and digital access controls, training, definition of acceptable storage locations and methods of communication, and other safeguards.
  • Embedded controls for trade compliance into an existing R&D shipping authorization system.
  • Reduced the risk of the company engaging with a sanctioned entity by selecting and implementing an enterprise-wide Denied Party Screening solution which screened >400,000 entities daily.
  • Enabled access to medicine for patients in an U.S.-embargoed country by obtaining U.S. Department of Commerce licensing for medicines and associated technology.
  • Apprised the business of anticipated and realized regulatory changes (e.g., Russia/Crimea, Iran, Venezuela) and assisted to analyze the potential impact and determine steps to reduce risk to the business.

Compliance Business Partner for Global Operations, 2016 - 2019

  • Supported the Organization and Culture, Training and Communication, Compliance Risk ID and Assessment and Standard Setting elements of the compliance program for a global function and 15 manufacturing sites across eight countries.
  • Increased compliance maturity for two new manufacturing sites by introducing compliance expectations including risk identification, governance, and controls and provided oversight for compliance framework development and implementation.
  • Devised and implemented novel approaches to engage with Global Operations leaders to embed AZ's Code of Ethics principles and expectations, and to facilitate online Conflict of Interest declarations in 13 languages, both using Nintex/SharePoint Online lists, forms, and workflows.

Management of Controlled Chemicals Lead, 2015 - 2019

  • Led the Management of Controlled Chemicals risk area within the Global Safety, Health, and Environment function.
  • Automated the identification of controlled chemicals by implementing and owning a global system; worked with varied stakeholders to optimize and support its use including production of a User's Guide, training, and consultations to enable connection with other software systems.
  • Led a governance team to ensure the system and associated controls appropriately mitigated risks of non-compliance while not unduly hindering transfer of materials between global research sites and collaborators.
  • Supported standard setting and monitoring/auditing by authoring the Global Standard and contributing to the audit work plan.

Global Compliance Resource and Project Manage, 2011 - 2013

  • Established a Portfolio Management Office (PMO) framework within the Global Compliance organization and introduced project management discipline including standardized monthly reporting and the use of common documentation throughout a project lifecycle.
  • Project Manager for projects spanning the areas of Auditing, Training, Communications, Anti-Bribery Anti-Corruption, and Export Controls and Sanctions.

Project Leader/Manager, Medicinal Chemist-Central Nervous System Disease Research, 1998 - 2011

  • Held positions of increasing responsibility within the research function where the goal was to identify a new chemical entity to progress into preclinical development.
  • Experience started as a lab scientist supervising a small team of chemists and culminated in leading a team of cross-disciplinary scientists through complex scientific and business decisions.

Honors & Publications


Credentials 

  • Certified Compliance and Ethics Professional (CCEP) - Society for Corporate Compliance and Ethics
  • Export Compliance Professional - EAR/ITAR (ECoP®) - Export Compliance Training Institute
  • Lean Six Sigma Green Belt (Delaware Manufacturing Extension Partnership) Graduate
  • Foundations in Project Management Course at Villanova University Attendee
  • Society for Corporate Compliance and Ethics Basic Academy Attendee

 Academic and Professional Affiliations

  • Professional Association of Exporters and Importers (P.A.E.I.)
  • International Compliance Professionals Association (ICPA)
  • Society for Corporate Compliance and Ethics (SCCE)
  • Organization of Women in International Trade (OWIT)

Awards 

  • Global Compliance Excellence Award in recognition of the development of AstraZeneca’s company-wide export controls and sanctions framework. 

Publications and Patents

  • Author and co-author of over 50 articles in peer reviewed journals, abstracts, posters, presentations, and patent applications in the areas of natural product total synthesis and drug discovery of new chemical entities targeting the treatment of pain and other diseases of the central nervous system, with focus on synthesis and pharmacological structure-activity relationships.

Education

  • Ph.D. Organic Chemistry, University of Minnesota, Minneapolis, MN
  • B.S.   Chemistry, Ohio Northern University, Ada, OH

 

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