Safis Solutions Leadership Team

Our leadership team has nearly a century of collective experience in life sciences and engineering.

 


John Nadelin

 

John Nadelin

 

John Nadelin is President & CEO of Safis Solutions, LLC. Nadelin joined Safis in early 2010, and his responsibilities include strategic leadership of Safis, establishing vision & strategy for growth, and developing the full potential of the Safis team to exceed customer expectations.

 

John has more than 30 years of life-sciences industry leadership spanning large pharma, biotech startups, and medical-device firms. Previous assignments include senior management positions in regulatory, quality, and pharmacovigilance with Pfizer/Pharmacia/Upjohn, Perrigo, Stereotaxis, and Targanta Therapeutics.  He also has extensive experience in managing FDA inspections and product recalls.

 

 

 


Mary Wood

Mary Wood is COO for Safis Solutions. Her responsibilities include providing QA/RA and compliance services to our clients, as well as overseeing the daily business operations related to client relationship management, operational business planning, and project management.

 

With over 20 years of medical device and pharmaceutical industry experience, Mary is a subject matter expert in medical device regulatory affairs. During her career, she has executed and managed several key projects, including Quality (Warning Letter Remediation), Lean Manufacturing (Shingo Prize) and Compliance improvements (Validation and CAPA remediation), R&D (Ureteral Stent and Packaging redesign) and Regulatory (510K submissions).

 


Don Poulsen

  Don P.

Don Poulsen serves as Vice President of Business Operations for Safis Solutions. Of his nearly 30 years of experience in engineering, 16 of them have been within the healthcare and life-science industries. He is responsible for operational aspects of the company including financial, human resources, and systems administration.

 

He earned two B.S. degrees, one in Mathematics and the other in Chemical Engineering, from the University of New Mexico.

 

He earned his M.S. in Petroleum Engineering from the University of Oklahoma.

 

 


Lance E. Wenck

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Lance E. Wenck, MBA is Director of Business Development for Safis. His role at Safis is as a lead in marketing and new business development for both national and international markets. He has over 15 years experience in sales, operations, and commercial management for the Medical Device, BioPharma, and Nutraceutical industries.

 

Prior to joining Safis Solutions, Lance served as a senior manager while leading corporate sales, business development, and account management functions. He has managed a diverse project portfolio, including market-analysis studies, product-feasibility profiles, and customer-satisfaction measurements. In addition, Lance brings hands-on operations management and project management experience from the Medical Device and BioPharma industries.

 

He holds a Master of Business Administration degree from Indiana University Kelley School of Business and a Bachelor of Science degree in Chemistry. Lance brings a strong expertise in data-driven, long-term strategic planning to the Safis Solutions business development team.