(Senior) Product Development Lead - Molecular Assay Development

(Senior) Product Development Lead - Molecular Assay Development

QIAGEN

Barcelona, Spain

Position Description:

We currently have a fantastic opportunity for a (Senior) Product Development Lead within our Molecular Assay Design & Development department. The successful candidate will work closely with QIAGEN experts and external development partners to lead the development of molecular diagnostics assays for Syndromic Testing in Infectious Diseases.

Key responsibilities:

• Lead holistically the development of new Syndromic Testing molecular diagnostics assays by heading an extended multidisciplinary team (assay, software & system integration) from product inception through development, transfer to manufacturing and verification;
• Lead a team of scientists to ensure project completion with technical quality and controlled development. Responsible for technical decisions within the project; technical delivery of project objectives; communicating technical status of projects; compliance with quality and regulatory standards;
• Support and liaise with Clinical Affairs and Regulatory Affairs to conduct clinical validation and submissions and support smooth product launches. Escalate and resolve technical project issues; conduct technical troubleshooting and root-cause analysis when required; and ensure appropriate risk analysis and mitigations;
• Work in partnership with Clinical, Regulatory and Quality Affairs providing technical input in interactions with European notified bodies and FDA; ownership of the Design History File; guaranteeing high-quality scientific delivery and compliance with industry standards (e.g. CLSI guidelines, ISO standards, 21 CFR part 820, IVDR);
• Coach and mentor scientific staff to ensure continuous development, sharing knowledge and best practices in order to build and nurture a connected and effective team.

Position Requirements:

Please ensure your application is submitted in English.

• PhD in Biological, Biomedical, Bioengineering Sciences or other relevant scientific disciplines;
• Scientific curiosity, analytical mindset, wish and ability to solve problems, innovate and introduce improvements aimed at developing best-in-class products;
• Significant research and development experience in diagnostics or molecular assays within industry or academia with a focus on some of the following: DNA/RNA extraction using manual extraction kits and/or automated instruments; multiplex Real-Time PCR manual setup and/or using automated instruments; next generation sequencing; molecular assay design; bioinformatics; automated molecular diagnostic systems; oncology, infectious disease or syndromic testing;
• Excellent communication and presentation skills with a track record of tailoring communication to the target audience. Experience of external stakeholder management and/or international customer partnering is highly desirable;
• Proven leadership experience in medium to high complexity environments ideally within product development. Excellent abilities in nurturing and coaching team members to support personal development and growth;
• Desirable: proven successful usage of regulated quality process (e.g. design control) and completion of design history files; understanding of industry standards (e.g. CLSI guidelines, ISO standards, 21 CFR part 820, IVDR).

Apply Now