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Summary

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.

Experiences

Current Experience

  • 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.

Past Experience

  • Team Leader Bioassay Development

    August 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

  • Team Leader Fungicide Discovery

    May 2002 --- June 2008
    fungicide and anti-microbial Discovery team lead, coordination of lead candidate Assay development and mode of action elucidation, lead of technology Innovation projects

  • Research associate

    January 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 associate

    August 1998 --- December 2000
    characterisation of the pancreatic Protein syncollin involved in digestive Enzyme secretion, determination of subcellular localisation, binding partners and oligomeric state (wellcome trust funding)

  • Research associate

    February 1995 --- July 1998
    characterisation of the molecular mechanism of the cortical granule reaction at fertilisation (swiss national science foundation & wellcome trust funding)

  • Graduate student

    April 1990 --- January 1995
    investigation of the molecular machnery involved in membrane fusion using secretory neuroendocrine cells as a model system.

  • Undergraduate Student

    January 1989 --- January 1990

Knowledge

LinkedIn Assessment :
Detailed knowledge of all aspects of bioassays including assay formatsSignificant appreciation of regulatory requirements for method validationGood working knowledge of analytical methodologies for biologicsELISAValidationBiotechnologyGMPCell Based AssaysCell biologyCell CultureSDS-PAGEHPLCWestern BlottingBiochemistrymolecular biologyLife SciencesBiopharmaceuticalsCellImmunologyTechnology transferImmunoassaysLifesciencesProtein chemistryAssay developmentLaboratory

Skills and Expertise

Self Assessment :
Analytical skillsExecute scientific projects

Education

  • Bachelor's Degree in Natural Sciences from Universität Basel in 1989
  • in from MNG in 1984

Languages

BrightOwl Assessment:
Self Assessment:
German
Native
English
Full Proficiency

Work Preferences

  • Notice Period:
    5 weeks
  • Positions I am interested in:
    R&D Scientist Biomedical Scientist Senior Associate Scientist R&D manager
  • Locations I am interested in:
    United Kingdom
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Reading, United Kingdom

Others

Driving License
  • Yes

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