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Experiences

Current Experience

  • Senior Site Manager - External Collaborations
    Since November 2015
    • Identification, evaluation, and management of third party contract manufacturers (CMO). • Collaborate with Legal to negotiate Master Service Agreements (MSA). • Prepare Requests for Proposal (RfP). • Lead and manage visits and contacts by Roche functions to CMO’s. • Proactively identify CMO risks, create strategies to avoid or minimize their impact. Manage the execution of risk mitigation plans. • Create purchase orders, review and approve invoices. Develop annual CMO budget (expense and capital) and monitor performance against plan on an ongoing basis. • Generate and distribute reports for overall site metrics, key issues, production status and highlights. • Manage competing priorities and allocate, adjust, and optimize assigned department resources. • Troubleshoot and direct the resolution of Collaboration issues by fostering effective interdepartmental and cross-functional partnerships. • Close collaboration with External QA.

Past Experience

  • Site Manager Contract Manufacturing
    November 2013 --- October 2015
    • Identification, evaluation, and management of third party contract manufacturers (CMO). • Collaborate with Legal to negotiate Master Service Agreements (MSA). • Prepare Requests for Proposal (RfP). • Lead and manage visits and contacts by Roche functions to CMO’s. • Proactively identify CMO risks, create strategies to avoid or minimize their impact. Manage the execution of risk mitigation plans. • Create purchase orders, review and approve invoices. Develop annual CMO budget (expense and capital) and monitor performance against plan on an ongoing basis. • Generate and distribute reports for overall site metrics, key issues, production status and highlights. • Manage competing priorities and allocate, adjust, and optimize assigned department resources. • Troubleshoot and direct the resolution of Collaboration issues by fostering effective interdepartmental and cross-functional partnerships. • Close collaboration with External QA.

  • Group leader in Formulation & Process Development
    January 2013 --- November 2013
    Development of IR coated tablets in special population Development of a pediatric dosage form incl. outsourcing Formulation development for highly potent, BCS 4 molecule Formulation development for a very BCS2 compound (logP >10) Due diligence for close-to-market product Post due diligence with Japanese partner Supervision of scientist and associates

  • Principal Scientist in Formulation Research
    August 2011 --- December 2012
    Due diligences: one front-office, one backoffice Conducting market research study on formulation in special population FAT and OQ of Zanasi Lab16 encapsulation Gaining credit approval of customized spray drier (internal/external fluid bed) Integrated outsourcing of a Ph1 development programme incl. clinical supply Formulation development for highly moisture sensitive API

  • Senior Scientist in Formulation Research
    March 2010 --- July 2011
    Preparation of URS/TS for customized spray drier Description of the roller compaction process using MVDA and DoE methodology (SIMCA+ & MODDE, main user for this technology) Post due diligence in-licensing of CNS compound Leading several biopharmaceutics subteams Continue to lead the projects from the years before

  • Lab head in Formulation Research
    October 2006 --- June 2010
    • Development of clinical Ph1 & Ph2 formulations for 6 compounds (MET, CNS) • special formulations: solid SMEDDS by adsorption onto porous carriers, gamma-cyclodextrin complexes, SEDDS, amorphous spray drying, SMEDDS • Handled two university collaborations • Member of technical and project teams • Lipid formulation specialist (SMEDDS, SEDDS) • Gastro+ & MODDE main user • Purchase and implementation of equipment (SADE capsule sorter, Rhön wheel blender, Zanasi Lab16 capsule filler) • Post due diligence in-licensing of 2 CNS compounds • Supervising two pharmacist trainees

  • PhD in Pharmaceutical Development– Oral Dosage Forms
    September 2003 --- September 2006
    stipendiate for a doctoral thesis • Cell culture on oral absorption (Caco-2) • Direct compression • Sintergranulation • Statistical experimental design • Oral semisolid dosage forms (SMEDDS)

  • Pharmacist in Process Development – Oral Dosage Forms
    July 2002 --- January 2003
    • Patent FTO analysis strategic product • Upscaling experiments of transferred product • Complete rearrangement of SOP system

  • Intern in Production Highly Active Drug Products
    July 2001 --- October 2001
    • Inspection readiness preparations • Writing, teaching and introducing SOPs • Cleaning validation plans

  • Intern in Cooperations Office – Logistics
    August 2000 --- March 2001
    • Information management • Programming of Lotus Domino databases • Examining/extracting in-licensing contracts/patents

  • Trainee Real estate Management
    January 1992 --- January 1995
    Dual education on real estate management: - accounting - finance - construction engineering basics - letting of flats - real estate law

Knowledge

LinkedIn Assessment :
PharmaforschungBiopharmazeutikaPharmaceutical ManufacturingGMPSolid Oral Dosage FormsFormulationMicroemulsionsPharmacyPharmaceutical process developmentExperimental DesignReal Estate EconomicsTechnologietransfer

Education

  • Doctor rer. nat. in Pharmazeutik und Arzneimitteldesign from Freie Universität Berlin in 2007
  • Pharmazeut in Pharmazie from Freie Universität Berlin in 2002

Languages

BrightOwl Assessment:
Self Assessment:
German
Native
English
Professional Proficiency
Spanish
Elementary Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Switzerland

Others

Driving License
  • Yes