Gerald Zimmer
Supplier Relationship Manager at Novartis Österreich- Claim this Profile
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Deutsch Native or bilingual proficiency
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Englisch Full professional proficiency
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Bio
Experience
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Novartis Österreich
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Austria
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Supplier Relationship Manager
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Jan 2021 - Present
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Sandoz
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Tech Transfer Manager
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Apr 2015 - Jan 2021
Tech Transfer Team Lead; Transfer of drug product manufacturing processes from Development into final commercial scale (Scale-Up) and facility. - Responsible for all related activities: timelines, milestones, detailed planning (API, excipients, raw materials), analytical method transfer, related documentation and regulatory submission support. - Interface position between different sites, departments and functions - Management of key stakeholders Tech Transfer Team Lead; Transfer of drug product manufacturing processes from Development into final commercial scale (Scale-Up) and facility. - Responsible for all related activities: timelines, milestones, detailed planning (API, excipients, raw materials), analytical method transfer, related documentation and regulatory submission support. - Interface position between different sites, departments and functions - Management of key stakeholders
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Program/ Projekt Manager Process Development and Tech Transfer
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Dec 2012 - Mar 2015
Lead of Process Development Teams for recombinant and gene therapy hemophilia products and Tech Transfer Teams.• Project organization and coordination of pharmaceutical development products • Lead of project subteams (CMC, Operations and Technology Transfer Teams) • Planning of material demands (drug substance, drug product) for preclincial and clinical studies • Interfacemanagement between different sites and departments • Responsible for associated documents (i.e. transfer protocols, risk assessments, change requests, submission chapters etc.) • Strategic planning and evaluation of pharmaceutical development projects Show less
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R&D Biomaterials
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Jul 2006 - Nov 2012
Bone regeneration, surgical products, hemostatic matrices, calcium phosphates and derivatives, analytical method establishment and optimization, DoE, statistical analysis
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Education
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Medical University of Vienna
Dr. Scient. Med. (May 2014), Doctoral program of applied medical science - bones and joints -
IMC Fachhochschule Krems
Diplom Ingenieur, Medizinische und Pharmazeutische Biotechnologie