Mike Cruskie, Ph.D.

Sr. Director and General Manager, API, Pharma Services
Florence, South Carolina, USA

Key roles and responsibilities

  • Lead team of more than four hundred scientists and technical experts at two Florence sites providing early phase development through commercial-scale and mid-scale manufacturing of active pharmaceutical ingredients (APIs)
  • Set strategic direction for project teams based on client input, serving as client liaison in early stages of project and overseeing subsequent development, assisting as necessary to help resolve issues and ensure delivery of the right solutions to meet client needs
  • Leverage new capabilities in manufacturing of highly potent compounds and the application of solid-state chemistry, commercial spray drying, micronization, and other technologies to solve extreme solubility challenges

Professional highlights

  • FDA Product Quality Microbiology and Biologics Licensing Applications (BLA) reviewer and pre-licensing inspection lead
  • Joined IRIX Pharmaceuticals in 1997 which was acquired by Patheon in 2015 followed by the acquisition of Patheon to Thermo Fisher Scientific in 2017
  • Has over twenty-five years of experience in pharmaceutical research and development
  • In February 2017, took over as general manager for new 300,000-square-foot facility acquired from Roche, now Thermo Fisher’s flagship API operation for commercial scale and mid-scale API production, in addition to existing Florence site
  • Before joining Thermo Fisher, served as vice president of operations for IRIX Pharmaceuticals, also serving as site manager for their Florence site
  • Previously led business development and supply chain for IRIX, and started career as a research chemist for Pfizer and Reilly Industries
  • Seven patents filed and/or pending
  • Member of the American Chemical Society, and board member of the University of South Carolina department of chemistry and biology industrial advisory committee

Education

  • Doctor of Philosophy in organic chemistry from the University of Florida
  • Bachelor’s degree in chemistry and mathematics from St. Lawrence University

Scientific expertise

  • Product development
    • Small molecule APIs
    • Strategy & process development
    • Process improvement/optimization
  • Operations and manufacturing
    • Technology transfer
    • Scale-up
    • Supply chain
    • Outsourcing