Stephan is a Global Quality leader in the pharmaceutical industry who has broad experience in CGT, biological, ophthalmic, sterile injectable and solid dose manufacture, packaging, and distribution, all in support of both commercial and clinical trial models. Stephan also holds experience in cGMP manufacture, testing, and quality assurance for supply within the US, EU, and the majority of major global regulatory markets.
Stephan is an experienced Qualified Person, Responsible Person, and Manufacturers Specials Quality Controller. Having worked for both small CMO scale and large, multinational ‘blue-chip’ pharma, Stephan brings a wealth of technical and leadership experience at both ‘site’ and ‘above site’ roles.
Prior to joining Dark Horse in October 2021, Stephan worked within Pfizer and Hospira at various ‘site’ and ‘above site’ leadership and technical roles, including Global Transport Quality Leader (Vaccines, GTx and Traditional supply), EU product release leader, and Regional EMEA Quality Leader. Special activities during this period included supporting the integration of the EMEA regional integration into Pfizer, QMS and product release remediation, and large-scale remediation of a sterile injectables facility located in India and a compounding facility located within the UK.
Prior to Pfizer, Stephan worked at Allergan, supporting the manufacture and distribution of both Biologic, Ophthalmic, and a range of alternative IMP dosage forms. Stephan worked as both a Qualified Person, Responsible Person and Manufacturers Specials Quality Controller on both UK and Ireland Licenses. Stephan also worked as both a QC Microbiologist and Quality Officer within Cobra Biomanufacturing supporting a large variety of activities.