About Karen

Karen Whitaker is a Certified Industrial Hygienist with over 25 years of extensive experience in the pharmaceutical industry. She has provided industrial hygiene and safety support across diverse operations, including manufacturing, pilot plants, clinical supply, packaging, and research environments. Throughout her career, Karen has been instrumental in enabling the safe handling of highly potent compounds by implementing at-source containment systems and specialized facility designs.

Her expertise encompasses leading containment performance assessments and conducting quantitative exposure assessments related to drug substance and drug product handling. Currently, Karen works in Merck’s Industrial Hygiene Center of Excellence, delivering global industrial hygiene support focusing on potent compound readiness at manufacturing and packaging sites across Europe and the Americas. In 2024, she co-led the update of the ISPE Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems (Third Edition).