John Clarke CMC Biologics

During his 28 years of experience in the pharmaceutical/biotechnology industry, John has been employed by Merck, Pfizer, and Sanofi, and has consulted with Wyeth, Bristol Myers-Squibb, Novartis, and Sanofi/Genzyme.   During his time in the industry, John has been directly involved in solid oral, vaccine, biotech, and sterile filling manufacturing operations.  John’s experience embraces Consent Decree Remediation, Quality Control, Technical Services, and Manufacturing Operations, with a career focus in establishing, executing, and leading validation /technical services teams and programs.

Some career highlights include; Consent Decree remediation for Qualification and Cleaning Validation at Warner-Lambert (1994-1998); Validation & Tech Services Head for Pfizer Tablet Facility start up in Cork, Ireland (1998-2000); Validation Program Leader for Wyeth Biotech Facility start-up in Dublin, Ireland (2001-2004); Consent Decree Remediation of Validation, Technology Transfer, and Drug Development at Genzyme, Boston, MA (2010-2014).

John is currently employed with CMC ICOS Biologics, in Seattle, WA, as the Director of Validation.