My name is Wen Liem (1974) and I’m a pharmacist by education (University of Utrecht).

I started my pharmaceutical career at Merck Generics (Registration & QA/QC officer, Qualified Person). I have fulfilled several roles at HAL Allergy (Industrial pharmacist, QC manager, Responsible Person (RP) and Qualified Person (QP)) and at Halix (as QP). I worked at ProQR Therapeutics, a start-up biotech company with a portfolio of Investigational Medicinal Products,. I was employed as QP where I was ultimately responsible for GMP compliance and batch disposition.

Experience with sterile manufacturing (drug substance, drug product), labeling, packaging and distribution.

• Release of registered and investigational medicinal products.
• Vendor selection and qualification
• Experienced auditor (GMP/GLP/GDP) of contract manufacturing organizations, contract laboratories and suppliers.
• Review of regulatory documentation (IMPD/IND/MAA)
• CMC development of Small molecules, Biological products and Oligonucleotides
• Setup Quality Management Systems and (continuous) improvements