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Summary

A biotech professional combining extensive international and multicultural experience with aptitude for applying scientific knowledge to lead cross-functional multidisciplinary projects, develop Biologics / Biosimilars and building successful partnerships. Specialities: • Cross Functional & Multi-Site Program Management • Monoclonal Antibodies • Biosimilars • Antibody & Protein Engineering • Mammalian & E coli Expression Systems / Production • Biochemistry, Molecular and Cellular Biology, Immunology • Technology Scouting, Development, Licensing & Implementation • Business Operations • Technology Transfer • CMC Selection, Compliance & Outsourcing • Early Stage Development up to GMP Manufacturing • Due Diligence & in-Licensing

Experiences

Current Experience

  • Global Programme Manager, Biologics Munich, Germany
    Since June 2014

    • Responsible for overarching coordination, control and completion of global cross‐functional biologics / biosimilars development projects in house, at contract service providers and in collaboration with other pharma and biotech companies. • Lead cross-functional strategic and operational development plans for a portfolio of biosimilar programs. • Lead international multidisciplinary programme team and the process of decision-making within the projects. • Contribute to key activities working with functions (Technical Development, Operational Planning, Pre-Clinical & Clinical Development, Regulatory Affairs, Intellectual Property, In Vitro / Companion Diagnostics) to ensure excellence in planning, budget forecast, decision making, risk management and communication. • Consolidate cross-functional programme information for reporting to steering committee and board. • Responsible for project budgets of assigned development projects of € 80‐100 M

Past Experience

  • Director, Technology Development & Antibody Engineering Grenoble & Lyon, France
    January 2010 --- May 2014

    • Member of the senior management executive team directly reporting to the CEO. • Scientific Management responsibility for a multidisciplinary team of 14 at different locations. • Customer Project Management including planing resources, timelines, budget and communication. • Responsible for Antibody, Molecular Biology, Mammalian Cell, USP & DSP Technology Platforms and the Company’s overall Technology Development and Innovation. • Portfolio management, overseeing the creation, design, development and commercial implementation of the Company's development programs. o Protein & Antibody Engineering, Humanization, Biosimilars o Mammalian Cell & Ecoli Protein Expression Systems o Cell Line Generation & Proprietary Cell Line Development o New Technology Development & Optimisation o USP and DSP Development o Bioassay Development o QC and Analytics for Product Characterisation o CMC Selection, Outsourcing and Compliance o Technology Transfer o Regulatory Documentation Drafting and Review o Due diligence, IP and R&D Representative in Business Development

  • Assoc Director, Biotherapeutics Development
    January 2008 --- January 2010
    • Development and manufacturing of therapeutic antibodies and proteins from early stage R&D up to cGMP production for Ph I clinical trials. • Responsibility for the planning and progression of customer projects and the management of daily operations within the Quality Control laboratories supporting the commercial and clinical product release. • Managed team activities in specific areas of analytical development, preclinical research, assay development, characterisation studies, regulatory documentation, process development. • Actively engage with customers and collaborators to ensure project issues are managed against timelines, resources and budget. o Protein & Antibody Engineering o Mammalian Cell & Ecoli Protein Expression Systems o Bioassay Development o QC and Analytics for Product Characterisation o CMC Selection, Outsourcing and Compliance o Technology Transfer o Regulatory Documentation Drafting and Review

  • R&D Director London, United Kingdom
    May 2004 --- January 2008

    • Reporting to CEO, design and development of protein and antibody microarrays for the identification and quantification of antibodies and biomarkers in human sera. • Development of multiplex immunoassay-based bio chips, associated lateral flow device and optical reader for clinical diagnostic applications (i.e. autoimmune, allergy, infectious diseases). • Evaluation and due diligence of leading edge platform technologies. • Overall responsibility for all technical activities associated with running the company, providing leadership and direction to an R&D team of 6-10 people

  • Team Leader/Project Manager London, United Kingdom
    December 2001 --- April 2004

    • Development of novel protein-based reagents for drug target validation. • Discovery and development of Protein Transduction Technology for the delivery of exogenous proteins, peptides and other active agents into cells. • As a lab supervisor in positions of increasing responsibility, explored and developed early-stage drug candidates in the in the field of immune diseases and cancer.

Knowledge

LinkedIn Assessment :
Monoclonal AntibodiesBiotechnologyMammalian Cell CultureProtein EngineeringTechnology transferProtein chemistryR&DBioprocessProject Portfolio ManagementAntibodiesCellBiochemistryImmunologyTeam BuildingUpstream processingAssay developmentStrategic PlanningDrug DiscoveryProcess SimulationGMPHigh Throughput ScreeningCross-functional team leadershipProtein ExpressionBiomarkersLife SciencesPharmaceutical IndustryBiopharmaceuticalsCell CultureDrug DevelopmentInfectious diseases

Education

  • Research Associate in Department of Biological Sciences from Imperial College London in 2006
  • Certificate in First Line Management in from Institute of Leadership and Management, UK in 2005
  • Post Doctoral Research in Department of Immunology and Molecular Pathology from UCL in 2001
  • BSc, MSc, PhD in Biochemistry from The Hebrew University in 1996

Languages

BrightOwl Assessment:
Self Assessment:
Spanish
Native
English
Native
French
Professional Proficiency

Work Preferences

  • Locations I am interested in:
    UK
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

London, United Kingdom

Others

Driving License
  • No