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Senior) Product Development Lead
hace 2 semanas
Overview
At the heart of QIAGEN’s business is a vision to make improvements in life possible.
We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees - more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic, international and diverse teams and want to make a real impact on people’s lives, then QIAGEN is where you need to be.
Join us. At QIAGEN, you make a difference every day.
Position Description
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
- 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).
What we offer
At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.
QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.
- JOB ID**
**EMEA04762**:
- COUNTRY**
**Spain**:
- LOCATION(S)**
**Barcelona**:
- DEPARTMENT**
**Research & Development**:
- EMPLOYMENT TYPE**
**Regular Full-Time**:
