Bohdan Bilyk

Senior Scientist @QIAGEN

Manchester, GB

As a Senior Scientist at QIAGEN, my main focus is guiding teams to develop new diagnostic tests within a regulated environment, while working closely with external partners like pharma companies, CROs, and suppliers- Team Leadership & Product Development: Led and managed a multidisciplinary team of up to 10 scientists through all stages of product development (proof of design-feasibility-performance-verification-validation) in a fast-paced IVD environment- Project & Resource Management: Planned, coordinated, and managed resource allocation for 5 concurrent assay development projects and associated studies, ensuring optimized execution and alignment with strategic goals- Client & Stakeholder Engagement: Managed key external relationships and fostered business partnerships with diverse stakeholders, including pharmaceutical partners, CRO representatives, and clinical sample suppliers. Developed and delivered compelling presentations, technical proposals, and pricing models tailored to influence stakeholder decisions and secure collaborations- External Partner Management (CROs): Managed relationships and collaborations with Contract Research Organisations (CROs), including personnel training, resource provision, and documentation support, ensuring successful site activation and clinical studies readiness- Quality Oversight: Oversaw quality control processes, interpreting complex data to guide impactful product design updates and drive continuous improvement initiatives- Regulatory Compliance & Documentation: Ensured strategic alignment and compliance with requisite quality and regulatory standards (ISO13485, ISO9001, IVDR, SOPs, GLP, GMP) through the generation and management of essential technical documentation for IVDs- Technical Project Execution: Directed the design and implementation of complex qPCR-based IVD assay development initiatives, translating technical requirements into viable diagnostic products.