lonza bilingual principal Scientist with focus on Cell based potency Assays in support of biologic Manufacturing of customer drug candidate molecules. development, transfer, maintenance, and optimisation of potency Assays, and Statistical analyses of bioassay data in support of batch release and stability studies in compliant GMP environment. biosafety representation of analytical function, certified in applied Statistics and experience with electronic Laboratory work books.
Principal Bioassay Scientist
Since July 2010
biopotency and immunoassay maintenance and Compliance. method development (doe), equivalence Testing (tost), method Troubleshooting and optimisation, GMP transfers, GMP validations (including anova analyses) and oos investigations aligned with lonza Policy. advisory role on potency platform Strategy for Preclinical and Clinical programs. customer facing oversight and Due Diligence over scientific and quality aspects of potency assay methodologies. biologic candidate batch release and stability Testing support within hse and quality regulations. definition of work packages, scheduling and resourcing support. responsible for analytical quality Documentation. regular participation at bioassay conferences. Biopotency and immunoassay maintenance and compliance. Method development (DoE), equivalence testing (TOST), method troubleshooting and optimisation, GMP transfers, GMP validations (including ANOVA analyses) and OOS investigations aligned with Lonza Policy. Advisory role on potency platform strategy for preclinical and clinical programs. Customer facing oversight and due diligence over scientific and quality aspects of potency assay methodologies. Biologic candidate batch release and stability testing support within HSE and Quality regulations. Definition of work packages, scheduling and resourcing support. Responsible for analytical quality documentation. Regular participation at bioassay conferences.
Team Leader Bioassay DevelopmentAugust 2008 --- July 2010
head of bioassay development group, management of bioassay Laboratory in analytical development for biologics department, analytical support to biologics project portfolio, GMP transfers and Qualification of binding activity, potency and hcp impurity methods, support of regulatory submissions
Research associateJanuary 2001 --- April 2002
elucidation of role of ph in the molecular mechanism of insulin signalling and glucose uptake into adipose tissue (Medical Research council funding)
Research associateFebruary 1995 --- July 1998
characterisation of the molecular mechanism of the cortical granule reaction at fertilisation (swiss national science foundation & wellcome trust funding)
Graduate studentApril 1990 --- January 1995
investigation of the molecular machnery involved in membrane fusion using secretory neuroendocrine cells as a model system.
Undergraduate StudentJanuary 1989 --- January 1990
Skills and Expertise
Analytical skillsExecute scientific projects
Bachelor's Degree in Natural Sciences from Universität Basel in 1989
in from MNG in 1984