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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Europe Project Management in the Pharmaceutical Industry

05 September 2019, Munich/Germany

  • Peter Reichert

    Peter Reichert

    Zelect Quality

    Peter Reichert holds a Master of Science in Food Science and Nutrition. He is a Consultant, GMP, QMS, Microbiology and CSV expert, Project manager and Lead-auditor with 25 years of experience within Research, Management, Microbiology and Hygiene, Device, Biotech, API, Fill and Finish and CMO Quality Enhancement and Oversight.

    Peter has gathered Management and QP experience in the area of device and biotech, and project management from several large and smaller projects during his 16 year-long employment with Novo Nordisk. Thereafter he has worked in the field of vaccines and is now operating as a consultant.

    He has been a PDA representative in the past at the Interested Parties meeting at EMA and has presented at the first PDA Quality Risk Management seminar and workshop for Industry and Regulatory in Geneva.

  • Stefan Schuh

    Stefan Schuh

    Bosch

    Stefan Schuh is a Senior Project Manager for Bosch Packaging Technology GmbH in Crailsheim. In this position he is also Deputy Director of Project Management and Site Coordinator for Project Management processes.

    The majority of the projects Stefan manages aim to deliver highly complex commercial filling lines for pharmaceutical companies all around the globe.

    Stefan is certified as an PMI® Project Management Professional.

  • Thomas Solver

    Thomas Sølver

    Eltronic Group

    Thomas Sølver holds a MSc in Pharmacy and is currently acting as principal Consultant within Quality management, Lead auditor and Qualified Person. Thomas has more than 25 years’ experience within the core pharmaceutical area. With this extensive experience within most disciplines within the pharmaceutical business, focusing on development, operation and quality management of API, finished pharmaceuticals, Biopharmaceuticals and medical devices.

    Thomas has been main contributor into pharmaceutical formulation development and optimization projects and has established unit operation and quality assurance of these and has broad experience with all operational disciplines connected to pharmaceutical processes. 

    Thomas has a multidisciplinary approach to the pharmaceutical business as he has experience with the development area, QM, project management and operational management area.

  • Garrett Van Vector

    Garrett Van Vactor

    Novartis

    Garrett Van Vactor is the Strategy and Transformation Management Lead for Novartis Global Development Quality (GDQ) based in Basel, Switzerland.  In his role, Garrett works with the pharmaceutical Development Quality organization in implementing the GDQ strategy and transformation agenda.

    Prior to joining Novartis in 2018, Garrett worked over 11 years at Deloitte Consulting focusing on business transformation projects for life sciences clients.  He also has previous experience working in the technology industry
  • Michael Walliser

    Michael Walliser, PhD

    CAMELOT Management Consultants

    Michael Walliser joined CAMELOT Management Consultants as a Managing Consultant and Head of Digital Culture & Capabilities in early 2019. Prior to his affiliation at Camelot, he was Partner and Operations Director of the management consultancy Conscious Performance GmbH. Michael has 15 years’ experience in pharmaceutical industry, combining management consulting and organisational culture. He is an acknowledged and certified specialist in the field of strategy development and reorganisation, in combination with organisational culture change (Prof. Hofstede Model) and leadership development. As partner of his customers, Michael is entrusted to lead and drive entire transformation programs to fulfil new strategic aspirations. Currently he supports transformations from high volume to high value manufacturing and from pilot batch production to market supply. Michael is a frequent speaker at conferences and author of a book chapter on multi project management standards.

    Michael Walliser received his PhD in Biochemical Pharmacology from the DFG Graduate School ‘Biomedical Drug Research’ at the University of Konstanz. Prior to becoming Partner at Conscious Performance GmbH, he worked for management consultancy firms and a pharmaceutical company.

  • Katrin Bernoester

    Katrin Bernoester, PhD

    Biotest AG

    Katrin started her carrier at Asta Medica as a lab head in drug discovery. During this time, she gained her first experience in project management as a preclinical project leader. Having worked for Almirall, she concentrated on CMC project management in an international collaboration. Since 2009 she has been working at Biotest AG. Here she steers the BNL product development program and became Vice President Corporate Project and Portfolio Management. She is responsible for the multi- and portfolio management, business development and IP at Biotest AG.

    She holds a degree in chemistry and a PhD in experimental biophysics from the Humboldt University Berlin.

  • Holger Eckert

    Holger Eckert

    Proventis
    Holger Eckert has been product manager of a multi-project management software solution for many years. After numerous implementation projects and continuous user feedback, he knows the problems, worries and pains that arise in daily multi-project management business. Resource management always plays a central role. Holger holds a master's degree in computer engineering and has many years of experience as a consultant for multi-project management seminars.
  • Mirko Gabriele

    Mirko Gabriele

    Thermo Fisher Scientific

    Mirko joined Patheon, now part of Thermo Fisher Scientific, in 2008 and has held various positions, including Technology Transfer Project Manager, Technical Business Manager, Manager of Technology Transfer Responsibility and Global TT Sr. Manager for commercial unit for the Ferentino team. He also has experience in Quality Control and Research and Development, both in Finished Products and API companies.

    Mirko led the Parenteral Drug Association (PDA) Group issuing the Technical Report 65 on Risk Management during Technology Transfer and is currently leading the PDA Global Technology Transfer Interest Group. He is member of the PDA Regulatory Affairs and Quality Advisory Board since 2014. Mirko received a Master Degree in Chemical and Pharmaceutical Technologies in 2004 at the University of Rome and in 2012 and Executive MBA in Pharma Administration at the Luiss Business School of Rome. Mirko is Qualified Person for the Italian Health Authority since July 2014.
  • Christoph Hoffmann

    Christoph Hoffmann

    Camelot Management Consultants

    Christoph is a Senior Consultant at Camelot Management Consultants AG and has more than five years of consulting experience in pharmaceuticals, automotive and logistics. He is an expert in enterprise information management with a strong focus on implementation projects of SAP MDG (Master Data Governance). His main activities lie in the area of project management, functional design and testing. He has project experience in different roles, e.g. as a functional expert, in quality assurance, as testing lead, trainer and SCRUM master. Christoph is Prince2 certified and has in-depth knowledge in organization design and change management.

     

  • Oliver Lehmann

    PMI Southern Germany Chapter

    Oliver F. Lehmann, speaker, trainer and author from Munich, has been a practitioner in project management for more than a decade before he became a skill builder in project management in 1995.

    In his almost 24 years in the profession, he has trained project managers in various industries, including pharma, in project management and prepared them for the internationally adored PMP certification. He studied humanities and project management at the Universities of Stuttgart and Liverpool and wrote groundbreaking books on situational project management and project business management.

  • James Newton

    James Robert Newton

    Novartis

    James started his career with Novartis by joining a rotational graduate program consisting of 3 assignments in 3 manufacturing sites, in Austria, Germany and Spain. The assignments involved working on various projects in site Quality and Manufacturing Science & Technology functions. Following the completion of these assignments he worked as a project manager for the global Quality organization managing the development of digital solutions for the product release process. James is currently a Process Expert in the production of biopharmaceuticals as part of a new Advanced Integrated Biologics Manufacturing unit.

    James holds a BSc Biomedical Science and MSc Drug discovery with Pharma Management.

  • Lucy Peltenburg

    Lucy Peltenburg, PhD

    Ganttenburg Consultancy

    Lucy Peltenburg combines a strong scientific background with 13+ years of industry experience in planning & modelling, project management and organization in biotech/pharma R&D. She has a PhD degree in molecular cancer biology and immunology and was Assistant Professor at the Leiden University Medical Center in the field of cancer therapy improvement. At Crucell (now part of J&J) she helped founding the Strategic Planning department and later became the head of the Program Management office. As head of R&D Operations at Prosensa (now part of BioMarin), she efficiently integrated operational and business planning in order to support R&D portfolio decision making, program acceleration and funding. To strengthen cross-disciplinary productivity in other expanding biotech & pharma companies and to help creating insight in the financial needs to achieve the next R&D milestones, she founded Ganttenburg Consultancy.

  • Peter Reichert

    Peter Reichert

    Zelect Quality

    Peter Reichert holds a Master of Science in Food Science and Nutrition. He is a Consultant, GMP, QMS, Microbiology and CSV expert, Project manager and Lead-auditor with 25 years of experience within Research, Management, Microbiology and Hygiene, Device, Biotech, API, Fill and Finish and CMO Quality Enhancement and Oversight.

    Peter has gathered Management and QP experience in the area of device and biotech, and project management from several large and smaller projects during his 16 year-long employment with Novo Nordisk. Thereafter he has worked in the field of vaccines and is now operating as a consultant.

    He has been a PDA representative in the past at the Interested Parties meeting at EMA and has presented at the first PDA Quality Risk Management seminar and workshop for Industry and Regulatory in Geneva.

  • Thomas Solver

    Thomas Sølver

    Eltronic Group

    Thomas Sølver holds a MSc in Pharmacy and is currently acting as principal Consultant within Quality management, Lead auditor and Qualified Person. Thomas has more than 25 years’ experience within the core pharmaceutical area. With this extensive experience within most disciplines within the pharmaceutical business, focusing on development, operation and quality management of API, finished pharmaceuticals, Biopharmaceuticals and medical devices.

    Thomas has been main contributor into pharmaceutical formulation development and optimization projects and has established unit operation and quality assurance of these and has broad experience with all operational disciplines connected to pharmaceutical processes. 

    Thomas has a multidisciplinary approach to the pharmaceutical business as he has experience with the development area, QM, project management and operational management area.

  • Michael Walliser

    Michael Walliser, PhD

    CAMELOT Management Consultants

    Michael Walliser joined CAMELOT Management Consultants as a Managing Consultant and Head of Digital Culture & Capabilities in early 2019. Prior to his affiliation at Camelot, he was Partner and Operations Director of the management consultancy Conscious Performance GmbH. Michael has 15 years’ experience in pharmaceutical industry, combining management consulting and organisational culture. He is an acknowledged and certified specialist in the field of strategy development and reorganisation, in combination with organisational culture change (Prof. Hofstede Model) and leadership development. As partner of his customers, Michael is entrusted to lead and drive entire transformation programs to fulfil new strategic aspirations. Currently he supports transformations from high volume to high value manufacturing and from pilot batch production to market supply. Michael is a frequent speaker at conferences and author of a book chapter on multi project management standards.

    Michael Walliser received his PhD in Biochemical Pharmacology from the DFG Graduate School ‘Biomedical Drug Research’ at the University of Konstanz. Prior to becoming Partner at Conscious Performance GmbH, he worked for management consultancy firms and a pharmaceutical company.

  • Alya Zriwil

    Alya Zriwil, PhD

    Novartis
    Alya Zriwil is currently a Quality Compliance manager for Novartis Technical Operations (NTO) based in Holzkirchen. In her current role, Alya works with the External Supply Operation organization for the development, implementation and continuous improvement of Quality processes, procedures and standards in compliance with cGMP/ICH, Regulatory Authority, and company requirements and policies.
    Prior to that, Alya was part of a development program within Novartis that introduced her to project management within the pharmaceutical industry at a global and local level.  
    She holds a degree in immunology and a PhD in biomedicine from the University of Lund in Sweden.