Work in Practice
Work in Practice.
These cases come from my time as an embedded scientist and R&D lead before founding Stumpf Co-Lab — at the Max Planck Institute and at Senostic GmbH, where I worked as a full team member, not an external advisor. They reflect the same way I work with clients today: inside the team, accountable for outcomes, building what actually needs to be built. I am sharing them because the work is real and the problems are representative of what life science companies face.
ISO 13485 QMS from scratch in a diagnostic startup
Challenge
An early-stage diagnostic company needed a fully documented Quality Management System compliant with ISO 13485 within 9 months, with no prior regulatory infrastructure and a team of four.
Approach
Built the QMS architecture from the ground up as an internal team member: document hierarchy, SOPs, risk management framework, and internal audit system. Co-prepared the team for the external audit and guided them through the review process.
Outcome
Full ISO 13485 certification achieved within the target timeline. The QMS has since served as the foundation for the company's ongoing regulatory development.
Building and leading a cross-functional R&D team in neurodegenerative disease diagnostics
Challenge
A biotech startup needed to simultaneously develop a biomarker discovery pipeline, build a functional lab, and coordinate with external CDMOs — with no existing team structure and tight timelines.
Approach
Defined the team architecture, recruited and onboarded scientists and a bioinformatician, established lab workflows, and set up project tracking and documentation systems from day one. Operated as both scientific lead and operational manager throughout.
Outcome
A functional, autonomous R&D team running parallel workstreams across biomarker discovery, assay development, and device prototyping within 18 months.
Managing a multi-site European research collaboration in protein engineering
Challenge
A protein engineering project required coordinating experimental work across two institutions in Germany and France, with different timelines, methodologies, and reporting requirements — while maintaining scientific output and publication targets.
Approach
Established shared deliverable frameworks, defined communication cadence, and served as the central point of accountability for progress and risk across both sites. Balanced scientific rigour with project management discipline throughout.
Outcome
Collaboration delivered on schedule. Results published in peer-reviewed journals. Methods contributed to the development of novel near-infrared fluorescent proteins now used in super-resolution microscopy.
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