Michael is an accomplished pharmaceutical technology engineer and expert in oral solid dosage (OSD) manufacturing, potent compound handling and facility design. Michael has spent his over 15-year career executing pharmaceutical projects from feasibility or business case through commissioning and validation assistance. Through this highly focused experience, he has developed in-depth knowledge of process design, material handling, equipment technology, containment, and facility layout in solid dosage, medical device, biological and aseptic facilities. Michael leverages this versatility in his role as director of process technology by providing technical leadership to IPS project teams and integrating the design deliverables of all process and facilities disciplines.

In addition to traditional design project execution, Michael is actively helping clients assess the risks of introducing potent compounds, solvents, and combustible dust materials into existing operations and facilities. The need for this skill set has never been higher, as manufacturers are increasingly faced with the task of retrofitting existing plants, many of which were not designed to handle these potentially hazardous materials.

Education

B.S. - Chemical Engineer, Drexel University

Professional Associations

International Society for Pharmaceutical Engineering (ISPE)
ISPE OSD Community of Practice, Steering Committee, 2017
ISPE OSD Community of Practice Continuous Manufacturing, Subcommittee Member, 2016
ISPE OSD Baseline Guide 2015-2016 Update Team
ISPE Industry Advisor (Drexel University) 2004-2006

Publications

Vileikis, Michael. “Continuous Manufacturing Principles: Linking Unit Operations and Eliminating Intermediate Bulk Storage.” Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2018 Supplement, 18 April 2018.
Vileikis, Michael. “Single Use Containment to Mitigate Contamination Risks.” Pharmpro.com, 20 March 2017.
Vileikis, Michael, et al. “Adapting OSD Capital Project Design to Continuous Manufacturing.” Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2016 Supplement, 1 April 2016.
Vileikis, Michael, et al. “Looking for a Challenge?” Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2015 Supplement, 1 March 2015.
Vileikis, Michael, et al. “Hidden Scale-up Hazards.” Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2014 Supplement, 1 February 2014.
Vileikis, Michael, et al. “Handling Hidden Scale-Up Hazards.” Pharmaceutical Processing, Vol. 29, Number 1, January and February 2014.
Vileikis, Michael. “Manual Cleaning in an OSD Facility - Will It Ever Go Away?” Pharmpro.com and Interphexblog.com, 27 October 2014.
Vileikis, Michael. “OSD Technologies and Trends Part 2.” INTERPHEXblog.com, 3 March 2014.
Vileikis, Michael, et al. “Multiproduct Facilities: Considerations Beyond Cleaning.” Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2013 Supplement, 1 April 2013.
Vileikis, Michael, et al. “Should it be Scale-Up or Scale Out… Bigger is Not Always Better or Faster.” Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2012 Supplement, 1 March 2012.
Vileikis, Michael, et al. “Multiproduct Facilities.” Podcast.

Presentations

Vileikis, Michael. “Capsules: The Go-To Dosage Form.” INTERPHEX, March 2017, New York City, NY.
Vileikis, Michael. “Design Considerations for Continuous Manufacturing and Practical Execution of CM Projects.” ISPE Facilities of the Future Conference, November 2016, Bethesda, MD.
Christofides, Andrew, and Michael Vileikis. “Continuous OSD Manufacturing Overview.” ISPE Annual Meeting & Expo, September 2016, Atlanta, GA.
Vileikis, Michael. “Fundamentals of Solid Dosage Continuous Manufacturing.” ISPE Delaware Valley Chapter, April 2016, King of Prussia, PA.
Christofides, Andrew, and Michael Vileikis. “Defining the Role of Engineering Firms in Facilitating OSD Market Adoption of Continuous Manufacturing.” INTERPHEX, Oct 2015, Puerto Rico.