BrightOwl Loader Loading

Summary

C-Level management: Operations, R&D, QM, RA, BD, IP, site- and profit center management. Entrepreneurial spirit - start up companies. Strong track record in customer and partner-oriented service and -consulting. International technology transfer management and third party asset management. Successful development of numerous value added and IP protected products. Strategic project and business management (corporate and international). Building and running GMP and QM operations. Good knowledge of regulatory environment (EMEA/CH) combined with CMC dossier writing (IMPD/CTD) skills. Specialties: Networking across and with different cultures. Wide interdisciplinary knowledge with respect to pharmaceutical technology, business development, licensing deals, manufacturing and process equipment, quality assurance and medical affairs.

Experiences

Current Experience

  • CEO of my own time
    Since March 2017
    Biotech/ Pharma/ Medical Devices/ Food Industry

  • Founding Partner/ Board Member
    Since September 2011
    Shareholder, Board Member, Advisor.

Past Experience

  • Sabbatical
    November 2016 --- February 2017
    Pursuing personal project endeavors in the NPD segment

  • Chief Scientific Officer
    April 2013 --- October 2016
    TASKS / COMPETENCES / DUTIES CSO, reporting to the Board of Directors: • Assumes all relevant technical, development, scientific and manufacturing activities and defined duties and responsibilities • Contributes to the sequences, systems and responsibilities of the QMH • Change Control (deviations – changes - recalls) handling • R&D - Budget planning and supervision • Definition of technological and R&D strategy • Planning and executing of development programs under consideration of capacity and financial implications • Coordinates and assures correct and state of the art development work • Management of contracts (CDAs, development contracts, inter-company contracts, quality assurance contracts, pharmacovigilance contracts). • Cooperation with partner companies, universities and technology suppliers • Representation of EffRx at corporate and investor meetings • Trend scouting • Supervises regulatory affairs activities • IP Management • Management of Pharmacovigilance operations towards outsourcing partners and customers • Oversees project management

  • CEO/ Founding Partner
    September 2011 --- March 2013
    Found and create a pharmaceutical joint venture R+D company from scratch. Put together business plan. Secure financing. Plan and execute on operational plan.

  • Director Corporate R&D
    May 2010 --- August 2011
    My global role encompassed the strategic and operational leadership of all R&D sites of the Temmler group and reported to the CEO of the holding corporation. A responsibility on the side was to sell and promote Temmler's R&D capabilities to key accounts, to attend fairs and represent the group to future customers.

  • Head Pharmaceutical Development
    February 2007 --- April 2010
    My responsibility reached from prototype / early stage development till commercial launch, overseeing the functional direct reports of galenical development, analytical development and regulatory affairs/ technical writing.

  • Head Formulation Development
    September 2004 --- January 2007
    Overseeing the process of finished product formulation development from early phase/ prototyping/ market testing all the way up to commercial scale manufacturing and technology transfer to third parties.

  • Head Galenical Development
    January 2000 --- January 2004

Personality

Self Assessment :
Analytical thinkingApproachabilityAdaptabilityCharmCoordinationCuriosityFlexibilityIndividualityPerspectiveProblem solvingResult OrientedSelf-disciplineStrategic thinking

Knowledge

Self Assessment :
Animal models Lab scale batches Negotiation R&D Scientific writingActions and modes of action of drugs in the human speciesAdverse Events (AE)Analytical techniquesBioavailabilityBiopharmaceuticalsBiotechnologyBudget ManagementBudget ProcessBusiness DevelopmentBusiness StrategyCAPAcGMPChange ControlChange ManagementChemistry, Manufacturing, and Controls (CMC)Clinical DevelopmentClinical Study DesignClinical SuppliesCMCCROCross-functional team leadershipCustomer ServiceDrug DeliveryDrug DevelopmentDrug development processDrug Safety and PharmacovigilanceDrug substancesDue DiligenceeCTDeCRFEMAEnglishEntrepreneurshipFinancial AnalysisFormulationsGalenicsGermanGMPGood Manufacturing Practice (GMP)Grant PreparationHealthcare industryICH guidelinesIMPDINDKey Account ManagementLeadershipLife SciencesmanagementManagement ConsultingManufacturingMergers & AcquisitionsMicrosoft OfficeMS ProjectNew Drug Application (NDA)OutlookOutsourcingPatentspeople managementPediatricsPharmaceutical DevelopmentPharmaceutical IndustryPharmaceutical ManufacturingPharmaceuticsPharmacokineticsPharmacovigilancePhases of clinical development (phase I to IV)Pilot scale batchesPreclinical developmentProblem SolvingProduct developmentProgram ManagementProject ManagementQuality Assurance (QA)Quality of Life (QoL) outcomesRegulatory affairsRegulatory submissionsSafety trialsSmall moleculesStability testsStandard Operating Procedure (SOP)Start-upsStrategyTeam LeadershipTechnology transferValidation
LinkedIn Assessment :
ValidationDrug DevelopmentRegulatory affairsClinical trialsGMPBiotechnologyLife SciencesResearch and Development (R&D)PHARMACEUTICAL INNOVATIONLeadershipEntrepreneurshipInternational BusinessCustomer ManagementR&DTechnology transferFormulation developmentPharmaceutical DevelopmentLicensingProduct developmentLifesciencesFormulationPharmaceuticsPharmaceutical IndustryQuality Assurance

Skills and Expertise

Self Assessment :
Analytical skills Build the CMC development plan Interpret data Lab scale batches Search literature on clinical trialsAdjust processes and methodsAdverse event reportingAdvise on strategyAssess product quality issuesAssist with site trainingAttend seminars, courses and meetings within and outside the companyAttend steering committeeCoach staffCollaborate with principal investigatorCollaborate with project teamCommunicate effectively on different company levelsConduct animal studiesConduct literature searchesConduct post-marketing surveillance studyContract approvalcontrol different protocol versions and other essential documentsCoordinate CMC-activitiesCoordinate projectsCoordinate regular advisory boardDesign of finished Investigational Medicinal Products (IMPs)Design post-marketing surveillance studyDevelop business planDevelop regulatory strategyDevelopment of late-stage cGMP production processesDirect co-workers to achieve resultdrafting grant applicationsEnsure data consistencyEstablish contractsEstablish professional relationships with partnersEstablish relationships with Key Opinion LeadersEvaluate licensing opportunitiesEvaluate physico-chemical dataEvaluate physico-chemical data of lab scale/pilot scale batchesFollow up projectsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesGuide staffGuide studentsIdentify growth / improvement potentialIdentify risksImplement Key Performance Indicators (KPI's)Implement Quality Management System (QMS)Interact with CROsInteract with KOLInteract with statisticiansLead studiesLead teamsManage budgetsManage complexityManufacture of non-GMP and GMP batchesMonitor Key Performance Indicators (KPI's)Negotiate budget NetworkOrganise steering committeePeople managementPresent at steering committeeproject managementR&DRegulatory documentationRegulatory submissionsRepresent CMC team Supervise PhD studentsSupervise techniciansUnderstand protocolsWork cross-functionallyWritten presentation

Education

  • International Executive MBA in Executive Management from IE (Instituto de Empresa) in 2009
  • PhD in Pharmaceutical Technology from University of Basel in 2002
  • Master in Pharmacy from Julius-Maximilians-Universität Würzburg in 1995

Training and Certification

  • International Executive MBA in 2009 Certification
  • Ph.D. in Pharmaceutical Technology in 2002 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
French
Professional Proficiency
German
Native

Work Preferences

  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    50 - 100% FTE
    BrightOwl freelancer :    40 Hours per week :    80% Free Per Month(in coming months)
    BrightOwl employee :    50 - 100% FTE
  • International:
    Yes

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Schindellegi, Feusisberg, Switzerland

Others

Driving License
  • Yes