Switzerland
Pharmacist with a PhD in Pharmaceutical Technology where I specialized on the development on protein delivery and analytics. Having worked in GMP commercial manufacturing including process development and product launch, I am used to working on multiple projects in parallel with a strong focus on quality in a timely fashion. This includes a 30M budget project qualifying and establishing a new pre-filled syringe isolator filling line.
Assistant production manager for state-of-the-art pre-filled syringe isolator of biotech drug products for world-wide supply with indirect leadership of 25-40 employees. • Responsible for the qualification of a new pre-filled syringe isolator filling line with focus on process design and implementation (~30M budget) • Product transfer of a biological to the new filling line • Support of commercial GMP production of two major biologics, media fills, filling line re-qualifications always including good documentation practice • Process development of new APIs in multiple projects: - Close collaboration with TRD to setup and implement processes, including compounding and aseptic filling, for innovative APIs (biologics and oligonucleotides) - Responsible for initial tech-batches, clinical supply and process (pre-) validations - Main responsible for two product validations, including one commercialization - Representative in health authority (FDA, SM, ANVISA et al.) and pre-approval inspections • Review of regulatory documents for product submissions
Semisolid Dosage Forms • Head of production (according to German law) and responsible for batch release from bulk production to tertiary packaged product • Responsible for deviation and complaint handling, including setup and installation of CAPAs • Representative in health authority inspections
Research (Controlled delivery of protein crystals) Teaching of students
Medical Devices (Production of Solostar Pen)