Randy Mack Email & Phone Number

Lake Forest, Illinois, United States

Lead for Microbiology on project teams. Lab responsibilities include the design and execution of method validation protocols for BET (gel-clot and kinetic), bioburden studies (API and finished product solutions), container closure testing, microbial filter retention validation, training of new colleagues and perform data review. Additional responsibilities include writing the Microbiology sections for submission dossiers, answering questions from regulatory agencies and organizing / reviewing studies with contract laboratories.

Lake Forest, Illinois, United States

Designed and executed method validation protocols for BET (gel-clot and kinetic), bioburden studies (API and finished product solutions), container closure testing, trained new colleagues, microbial filter retention validations and perform data review. Responsibilities also included writing the Microbiology sections for submission dossiers and organizing / reviewing studies with contract laboratories.

Abbott Park, Illinois

Designed and executed method validation protocols for container closure testing, microbial filter retention validation, BET (gel-clot), trained new colleagues and perform data review.