Dr. Andreas Koop

Lab IT Consultant / IT Project Manager (external consultant) @ Bachem

About

All-rounder with 29 years of experience in the healthcare domain including 19 years in the Life Science Industry (Pharma, BioTech and Diagnostics). Deep experience with the associated regulations. Complete overview of the entire clinical research process and related software support: LIMS (for biobanking, clinical trials, production QC), ELN, EDC, ePRO, CTMS, eTMF, business/clinical intelligence/reporting/integration, business process management, hospital information systems and health industry trends in general. On an executive level, several partnerships have been established providing win-win situations for the companies involved. Project Management and Computerized System Validation (CSV) in waterfall, agile and hybrid approaches in small teams as well as in large international organizations on a global level. Ability to dive into new topics very quickly. Highlights: • 2 programs, 22 projects (CSV) and 4 projects / initiatives (non-CSV) (see list of projects below) • Proven track record of aligning diverse business functions to common goals and strategies • Business development including academic partnering Interests: • Apply new approaches and technologies to create value • Generate and launch new products that make a real difference • Build and lead effective teams to make the above happen

Country

Switzerland

City

Baar

Industry

Government Administration

Skill

Projektmanagement, Project Management, Management, Informatics, Pharmaceutical Industry, Pharmaindustrie, Abteilungsübergreifende Teamführung, Software-Projektleitung, Biotechnologie, Klinische Studien, Biowissenschaften, Klinische Entwicklung, Veränderungsmanagement, Computervalidierung, Informatik, Unternehmensführung, Unternehmensanalyse, Software Project Management, Agile Methodologies, Agile Project Management

Experience

Lab IT Consultant / IT Project Manager (external consultant)

Bachem

2024-6 - Present · 2 yrs 4 mos

Bubendorf, Basel-Country, Switzerland

Supporting the BELT project (selection and introduction of an ELN) and the digitalization of the weighing process. Project management for the Digital Qualification and Validation project introducing Kneat Gx for the C&Q process.

Senior Life Science Consultant (external consultant)

Lucie by PharmaTrail

2023-9 - Present · 3 yrs 1 mo

Basel, Switzerland

Supporting the definition and implementation of an audit-ready GxP compliant QMS

Senior Life Science Consultant

Kvalito Consulting Group

2023-2 - Present · 3 yrs 8 mos

Basel, Switzerland

CEO and Founder

The Personal Medical Record Initiative (TPMRI) UG

2020-12 - Present · 5 yrs 10 mos

Freiburg, Baden-Württemberg, Germany

Setup as a German "gemeinnützige UG", so a social, non-profit organization.

CEO and Co-Founder

BFSTS GmbH

2018-7 - Present · 8 yrs 3 mos

Hünenberg, Zug, Switzerland

Consulting and product development

Senior Life Science Consultant (external consultant)

Clarivate

2023-2 - 2024-1 · 1 yr

Barcelona, Catalonia, Spain

Supporting the development and implementation of an efficient GxP compliant agile SDLC.

Quality Coordinator (external consultant)

Lonza

2021-2 - 2022-11 · 1 yr 10 mos

Visp, Valais, Switzerland

Core team member of the Lonza Badile Operational Separation (BOS) project supporting the spin-off of Lonza Specialty Ingredients (LSI), sold for 4,2 bio CHF Coordination of Lonza and Arxada quality departments to ensure that quality is not compromised during and after the carve-out of LSI (now Arxada) Business analysis of quality-related requirements / tasks of the carve-out Project management / support of related projects, such as access control, material separation, logical system separation (e.g. LIMS, knowledge management / intellectual property), physical archive separation Project management of a SwissMedic scientific advice meeting and a carve-out site inspection (as part of the general site inspection)