Michael has over 29 years of experience working in the pharmaceutical, biotechnology, and consulting service industries. His primary role is to facilitate new business partnerships and investments for Azzur and its subsidiaries. He oversees the complete management process and delivers executive decisions supporting Azzur’s success.
Prior to Azzur, he held high-level management positions in several companies including CQV, and Stelex Inc. Michael uses his expertise in business strategy and quality assurance to ensure proper management and advance the growth of Azzur.
Michael’s favorite color is orange. He is married with two children. His hobbies include setting up an annual model train display at Reading Terminal Market ACME Railroad and sailing on his boat Com Pari Brieze. Michael received his Bachelor’s degree in Computer Science from Temple University.
Dave has over 20 years experience in consulting in the FDA regulated and water treatment industries. He is a co-founder of BioSPEQ, Inc., a full-service consulting firm to the biotech/pharmaceutical, medical device, and food/cosmetics industries that merged with Azzur in 2014.
Dave has undergraduate degrees in Biochemistry and Chemical Engineering and a Master of Engineering degree in Chemical Engineering, all from the University of Ottawa. Dave a registered professional engineer in Ontario, Canada.
Kevin has over 38 years of FDA regulated industry experience that includes management positions at Wyeth and McNeil Pharmaceutical. He is considered a subject matter expert on risk-based systems validation conducted within QA, IT, Manufacturing, Operations, Clinical and R&D in FDA regulated environments.
He was a member of the PhRMA Computer Systems Validation Sub-Committee, was the Core Team Secretary for the PDA Part 11 Task Group and was previously a chair on the GAMP Americas Steering Committee.
He received his Bachelors degree in Chemistry from Delaware Valley College of Science and Agriculture and his Master of Engineering from Penn State University.
Mark plays an active role in facilitating the success of Azzur Group and its partner companies including Azzur Labs, Azzur Technical Services, Azzur Engineering, Validation, Inc., AZOT, 3Seed Marketing, Design & Interactive, and LiveHelpNow.net.
As a professional Entrepreneurial Operating System (EOS) implementer, Mark helps business owners get what they want from their business. At the end of the process, each leadership team he works with is on the same page and rowing in the same direction.
Mark earned his A.A.S in Electronics Engineering from Lincoln Technical Institute, a B.S. in Business Administration from Albright College and a M.B.A. from Northeastern University. He is a 1st degree black belt in Tae Kwon Do and participates in various marathons and triathlons including Tough Mudder. He is married and has three children.
To find out more about Mark's work as an implementor of EOS visit his blog here
Ryan is responsible for developing new business opportunities and managing projects and employees within the Northeast United States.
Ryan has 18 years experience working and consulting in a variety of FDA-regulated environments including pharmaceuticals, biologics, and medical devices. His past experience reflects a broad understanding of IT Quality & Compliance, with projects ranging from stand-alone systems to enterprise-wide solutions; supplier quality audits; IT infrastructure and data center build-out; disaster recovery and business continuity; software development life cycle & validation; system integration, retirement and data migration; automated manufacturing systems; QC laboratory support systems; medical device quality management systems; document management systems; facilities/maintenance management; and pharmaceutical drug sample tracking systems. He has an in-depth understanding of current GxP regulations and industry best-practices, including GAMP.
Ryan is a member of professional organizations such as PDA, ISPE and ASQ. He holds a bachelor’s degree in biology from Allegheny College and has studied Regulatory Affairs & Quality Assurance at Temple University.
Thomas leads sales and recruiting for Azzur Group and it’s subsidiary Azzur Consulting. As the co-founder of Validation Inc., a consulting business he began with his brother Mark O’Donnell, Tom has played a hands-on role in the growth of Azzur Group. His previous experience includes working with large engineering and validation consulting companies as a mechanical validation consultant and in AutoCAD and 3D modeling.
Thomas is active member of the entrepreneurial group Inc. Business Owners Council and the life sciences organization ISPE.
He is an avid soccer player and plays in a league on the weekends. He also enjoys watching and playing football. When it comes to technology, Thomas is a self-proclaimed tech geek and will admit to an incurable need to own every new device as soon as it comes out.
Thomas is married and has two sons. He received a Bachelor’s in Business from Albright College and an A.A.S in Mechanical Drafting from Lincoln Technical Institute.
Shaleen is a co-founder of BioSPEQ, Inc., a full-service consulting firm to the biotech/pharmaceutical, medical device, and food/cosmetics industries that merged with Azzur in 2014.
He continues to use his extensive cGMP experience in project management, quality system development, validation and process engineering to facilitate growth for Azzur. He is also focused on continuous improvement and operational excellence, driving key strategic projects to meet customer requirements in a timely manner.
Shaleen is an avid fan of the NBA (Los Angeles Lakers) and NFL (Indianapolis Colts). He received his B.S. in Biological Sciences from the University of California, Irvine and M.S. in Physiological Sciences from the University of California, Los Angeles.
Brian is a co-founder of BioSPEQ, Inc., a full-service consulting firm to the biotech/pharmaceutical, medical device, and food/cosmetics industries that merged with Azzur in 2014.
Brian is a board member of the Parenteral Drug Association (PDA), Southern California Chapter. His duties include program design, establishing work/role objectives, and execution of various tasks.
Brian is an active volunteer member of HOPE worldwide, an international charitable organization providing services and resources that bring hope and change to the world’s most poor, sick and suffering. He is currently involved in leading the coordination and execution of community-based projects focusing on improving the conditions and bringing positive impact to the lives of children in the foster care and adoption system.
He is a graduate of California State University-San Bernardino and University of California, Irvine.