Greater Freiburg Area
In-depth R&D knowhow Molecular biologist having more than 18 years working experience in R&D of diagnostic assays for high-throughput laboratory & point-of-care applications. Broad business experience Manager and consultant with MBA having worked in different roles in R&D, Business Development and Operations, and experiences in various areas including product & method development, production/operations, strategic business development, sales of services, quality assurance & regulatory affairs. Passionate Leader of people & projects Leader of departments with up to 50 members of staff organised in several teams and Leader of multiple projects with stakeholders from different disciplines, management levels and nationalities.
Consulting service for the Diagnostics Industry. Past project working for > 12 months as Freelance Consultant in R&D of a leading company for autoimmunity diagnostics, managing an immunoassay IVDR project & supporting a remediation project.
Integration of PCR assays for infectious diseases and responsibility in managing external R&D stakeholders and optimisation of design transfer & quality control processes - Leading project with Assay R&D team and Quality control & QM - Process optimisation and validation according to ISO13485 - Risk analyses according to ISO14971 - Supplier management and auditing of suppliers of critical assay components - Troubleshooting of assay-related technical issues in current products or new products in development
Head of Method Development & Production/Service Laboratory managing a total of 50 employees in two departments with multiple teams, at Eurofins GeneScan, Freiburg, Germany Head of Method Development (Responsibilities/Achievements) - Multi-Project management of assay development and validation projects for external customers and lab automation solutions (e.g. Hamilton pipetting robots, Thermo KingFisher) for internal use - Sales of development services to global customers including preparation of quotes and legal contracting - Developing new business areas for the company from a technical and market perspective Head of Production/Service Laboratory (Responsibilities/Achievements) - Sales of new testing services for COVID testing - Continuous performance review and process improvement implementing Lean principles in laboratory processes to guarantee results at high quality and short turnaround time - Optimization of consumable costs and warehouse management
Head of Product Development and Business Development Manager at Gold Standard Diagnostics (formerly Eurofins GeneScan Technologies), Freiburg, Germany Substitute of Managing Director and authorized representative (Prokurist). Product development manager (Responsibilities/Achievements) - Supervision of product development department with 20 scientists and technicians in different teams (Molecular Biology, Microbiology, Virology, Immunoassay, Nucleic Acid Extraction & Automation) - Budgeting for product development department - Optimisation of the development & documentation process to meet requirements of ISO 9001:2015 and aspects of ISO 13485 for certified diagnostic products - Primary contact to certification bodies and responsible for compliance with product certification regulations (e.g. AOAC, AFNOR) - Stakeholder management of different external (e.g. customers, suppliers, certification bodies, authorities) and internal stakeholders from various organizational levels and different nationalities Business Development Management (Responsibilities/Achievements) - Responsible for integrating newly acquired Immunoassay company and technology into the existing business: Hiring staff, designing and equipping laboratories, re-certification of diagnostic kits in < 1 year - Supervision of preparation of business cases (BC) for developing a new product-line in virus diagnostics and a complex BC for nucleic acid extraction/automation including market & competitor analysis, portfolio development & marketing strategy, and financial appraisal - Screening and assessment of patents, independently and in collaboration with professional patent researchers and attorneys - Support of corporate M&A team in technical evaluation of potential target companies - Review and editing of legal and commercial contracts (e.g. CDAs, MTAs, Supply agreements)