Product Lifecycle Responsible R&D Scientist - Pathology

Product Lifecycle Responsible R&D Scientist - Pathology

Agilent Technologies

Glostrup, Denmark

Will you join us in the fight against cancer?

We are seeking an experienced R&D Scientist to take ownership of lifecycle responsibilities for one of our Pathology product lines. In this role, you will help sustain state-of-the-art in vitro diagnostic devices that make a real difference for patients worldwide.

Your key responsibilities will include driving design control activities throughout the product lifecycle, maintaining and updating risk management files to ensure compliance. Supporting sustaining and enhancement activities to uphold product quality and performance.

All work will be performed in alignment with relevant regulatory guidelines and industry standards.

Your tasks will include:

• Planning, generation and update of Design Control documentation according to Agilent Quality Management System (QMS);
• Writing of study protocols and reports including data analysis;
• Document and specifications writing;
• Product care initiatives such as design changes to existing products;
• Post Market Surveillance activities;
• Complaint handling when R&D support is needed for root cause investigation;
• Stakeholder management/communication (internal and external);
• The stakeholders for the product line you will be responsible of mainly are in US, so expect meetings late afternoon/evening from time to time;
• Act as subject matter expert during internal audits and external inspections.

Qualifications

We are looking for a motivated individual with the following background:

• Master’s/PhD in Biology, Biochemistry, Biotechnology or similar;
• Proven experience of at least 1-2 years within design control of Medical/Diagnostic devices;
• Knowledge of IHC (Immunohistochemistry), ISH (in situ hybridization) or special stains is a plus;
• Knowledge of Companion Diagnostic (CDx) reagents is a plus;
• Full fluency in English. Note that Danish is not required.

On a personal level, you are rigorous, driven and process oriented. You also have excellent interpersonal and communication skills to interact with many external and internal partners. You enjoy working both autonomously and as part of a team. Whilst being flexible and adaptable, you have also strong planning, organizational and time management skills.