Leadership Team

• Christian F. Wertz, PhD

  President

  
  

  Christian F. Wertz, PhD

  President

  As President, Chris is responsible for all day-to-day operations at Flex Pharma. He is a seasoned pharmaceutical executive with nearly 25 years of industry experience. Chris has worked directly on NCE, 505(b)(2), and ANDA programs and recently led the successful development of Phyrago, the first FDA-approved product leveraging ElectroNanoSpray™ technology.

  Prior to joining Flex Pharma, Chris held positions of increasing responsibility at Elan Corporation, Vertex Pharmaceuticals, Upsher-Smith Laboratories, and Nanocopoeia, assuming oversight of preformulation, formulation and process development, analytical development, clinical development, regulatory affairs, project management, and intellectual property.

  Chris is an inventor on over 20 US patents and holds a BS in Chemical Engineering from the University of Minnesota and MS/PhD degrees in Chemical Engineering from Lehigh University.

• Jennifer Pilate

  Sr Director, Regulatory

  
  

  Jennifer Pilate

  Sr Director, Regulatory

  As Sr Director of Regulatory Affairs at Flex Pharma, Jennifer oversees regulatory strategy and execution for the company’s drug development programs. As a seasoned regulatory affairs leader with over two decades of experience in the pharmaceutical industry, she has developed deep expertise in managing 505(j) and 505(b)(2) applications, guiding numerous products from development through approval with a strong track record of success.

  Prior to joining Flex Pharma, Jennifer held regulatory positions of increasing responsibility at Paddock Laboratories, Perrigo, Chemi Pharma, Milla Pharmaceuticals, and Nanocopoeia. Jennifer holds a BS degree in Biology from Bemidji State University.

• Joe McTarsney

  Sr Director, Pharmaceutical Sciences

  
  

  Joe McTarsney

  Sr Director, Pharmaceutical Sciences

  As Senior Director of Pharmaceutical Sciences, Joe leads the Formulation, Process, and Analytical Development functions at Flex Pharma. He has over 24 years of experience in various R&D roles in the pharmaceutical industry, leading technical teams and contributing to multiple successful IND/ANDA/NDA filings and commercial product approvals.

  Prior to Flex Pharma, Joe held roles in analytical development and preformulation at Nanocopoeia and Upsher-Smith Laboratories where he developed deep expertise in analytical chemistry, solid-state characterization, and CMC. Joe has a Bachelor’s Degree in Chemical Engineering from the University of Minnesota.

• Sue Schilling

  Sr Director, Quality

  
  

  Sue Schilling

  Sr Director, Quality

  As Sr Director of Quality Operations, Sue manages all quality and compliance functions at Flex Pharma. With over 30 years of experience in the pharmaceutical and medical device industries, she has designed, implemented, and validated manufacturing processes at contract manufacturers across the globe.

  Prior to joining Flex Pharma, Sue was head of Quality at Nanocopoeia where she was instrumental in ensuring GMP compliance of the ElectroNanoSpray™ platform technology. Sue holds a BS degree from St. Thomas University.

• Huijing Fu, PhD

  Director, PharmTech & Engineering

  
  

  Huijing Fu, PhD

  Director, PharmTech & Engineering

  As the Director of Engineering and Pharmaceutical Technology, Huijing Fu leads the design and development of the proprietary Flex series spray dryers, and oversees technology transfer and manufacturing of the company’s pipeline. With over 15 years of experience in engineering design and development, scale-up, process engineering, and GMP manufacturing, she brings deep technical and leadership expertise to fast-paced, innovation environments.

  Prior to joining Flex Pharma, Huijing was lead engineer at Nanocopoeia where she was instrumental to the design and scale-up of the ElectroNanoSpray™ technology platform. Huijing holds a PhD in Environmental and Chemical Engineering from Washington University in St. Louis.

• Sean B. Mahoney, M.A., J.D.

  Legal and Intellectual Property Advisor

  Sean B. Mahoney, M.A., J.D.

  Legal and Intellectual Property Advisor

  Sean is an attorney with over 20 years of experience in the pharmaceutical industry, both as in-house counsel and in private practice. Supporting ANDAs, NCE and 505(b)2 NDAs, and drug-device combo products, Sean has worked extensively on patent protection strategies and patent procurement, due diligence, patent litigation/Hatch-Waxman matters, trademark strategies, and regulatory strategies for numerous pharmaceutical products. Previously, Sean was in-house counsel at Upsher-Smith Laboratories and practiced patent law at Faegre & Benson (now Faegre Drinker). Sean studied chemistry at St. John’s University (Minnesota) and the University of Texas, and holds a J.D. degree from the New York University School of Law. Sean is a registered patent attorney, and is admitted to the Minnesota state bar, the Federal Circuit bar, and the United States Supreme Court bar.

• Anand Rai

  Strategic Business Development Advisor

  Anand Rai

  Strategic Business Development Advisor

  Anand Rai is a seasoned pharmaceutical executive, advisor, and consultant with extensive experience in commercial strategy, business development, product development, and alliance management. As Principal Consultant at ARAI Consulting Services LLC, he advises pharmaceutical and healthcare companies on commercialization, product portfolio management, and growth strategies, leveraging a global network and deep market insights. Previously, Anand held leadership and ownership roles at Cameron Pharmaceuticals, Rising Pharmaceuticals, and PACK Pharmaceuticals, driving product launches, corporate growth, and strategic partnerships in both brand and generic segments of the market. Anand also has an extensive background in consulting and advisory services with companies such as Boston Consulting Group. He holds a PharmD and an MS/MBA in Pharmaceutical Marketing from St. John’s University, and combines technical, strategic, and business expertise to deliver impactful results.