Gerhard Schneider

Fähigkeiten und Kenntnisse

Änderungskontrolle
Arzneimittelzulassung
Biopharmaceuticals
Biochemie
Biopharmazeutika
Fermentation
Bioprocessing
Fertigung
Biotechnologie
Forschung und Entwicklung
Biotechnology
Regulatory Affairs
GMP
SOP
Lebensmittelüberwachung
Biowissenschaften
Technologietransfer
Lifesciences
CAPA
Molekularbiologie
Characterization
Technology Transfer
Pharmaceutical Industry
Charakterisierung
Validation
FDA
Pharmaindustrie
recombinant DNA technology

Werdegang

Berufserfahrung von Gerhard Schneider

  • Bis heute 10 Jahre und 8 Monate, seit Jan. 2016

    Managing Director

    biotech competence gmbh

    Consulting - development, change process, investments and quality compliance innovation - independent projects, take up new ideas and coordination of partner projects interim management - production, development, innovation management, investments and third party operation please visit our website - http://www.biotechcompetence.com - for detailed information

  • 1 Jahr, Jan. 2015 - Dez. 2015

    Project Manager Site Head Anti-Infectives Kundl

    Sandoz

    Ensuring end-to-end technical oversight of product manufacturing processes at all stages of their commercial lifecycle Developing and implementing global standards for specific manufacturing technologies Developing, implementing and managing validation of processes

  • 2009 - 2014

    Biotech-Production - Head Biotech Operations

    Sandoz

    Management of upstream bioprocess plant (2500 m3 fermenter volume) and downstream processing intra- and extracellular enzymes Identification and implementation of improvements in respect of quality, economy and ecology Initiation of investments projects and their implementation Realization of tech transfers and contract manufacturing Improvement of quality standards and compliance Introduction of sustainable product methods

  • 2003 - 2009

    Development - Head Fermentation

    Sandoz

    Management of upstream bioprocess development (from lab to production) Bioprocess development of bio-pharmaceuticals in phase I to III Coordination development activities with Novartis Development of concept for tech transfer from external partner companies Bioprocess development of biosimilar products Upstream bioprocess development of pharmaceuticals and enzymes Continuous improvement of processes for commercial products Coordination development and introduction of new technologies including cooperations

  • 1993 - 2003

    Development - Head Pilot Plants

    Sandoz

    Management of upstream pilot plants Coordination upstream bioprocess development of bio-pharmaceuticals, pharmaceuticals and enzymes Coordination development projects

  • 1987 - 1993

    Development - Head Lab Pilot Plant

    Sandoz

    Management of upstream pilot plant up to 150 L scale Bioprocess development Coordination of development projects (project manager)

  • 1982 - 1987

    Development - Lab Fermentation

    Sandoz

    Bioprocess development in lab and upstream bioprocesses

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