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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. • 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 thesisCell 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

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