Principal Scientist, Quality Control

Danaher Corporation; England; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading company in cancer diagnostics is seeking a Principal Scientist, QC, to manage quality control for new products. The role involves utilizing histology and molecular techniques to ensure product reliability and compliance in a regulated environment, contributing to innovations in cancer diagnostics.

Qualifications

• Proven experience in a regulated scientific environment.
• Familiarity with histological/immunohistochemical techniques.
• Experience within Quality Control or Assurance.

Responsibilities

• Lead QC projects related to new product development.
• Plan and conduct QC duties for medical device products.
• Participate as a QC representative in cross-functional teams.

Skills

Histology

Immunohistochemistry

Quality Control

Molecular Techniques

FISH Techniques

Education

Degree in Biomedical Science or related field

Tools

ISO13485

Good Document Practice

Job description

Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.

Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

The Principal Scientist, QC for Leica Biosystems is responsible for leading projects in relation to Quality Control requirements. This role will utilize Molecular/FISH/IHC experience and knowledge to ensure that QC testing is adequate to ensure product performance in relation to new products.

This position is part of the Quality Control (QC) team located in Newcastle, United Kingdom and will be an onsite position. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.

You will be a part of the QC team and report to the QC Manager responsible for ensuring that all design review and production readiness activities in relation to Quality Control are met to ensure the successful transfer of new products to the QC department. This is inclusive of all streams within the QC Department. If you thrive in a multifunctional and fast paced role and want to work to build a world-class Quality organization—read on.

In this role, you will have the opportunity to:

• Be responsible for planning, organizing and conducting duties related to Quality Control – New Product Development and Lifecycle Projects
• Proven and demonstratable experience with IHC, molecular or FISH techniques
• Identify tissue commonly used in QC Testing.
• Assess IHC / FISH Staining Techniques.
• Slide screening of Class I, II and III Medical Device products.
• Act as part of a team, or as a project lead, if required.
• Participate in cross-functional teams at various phases of the development cycle as the Quality Control representative.

The essential requirements of the job include:

• Proven and demonstratable experience within the biomedical field.
• Experience of working within a regulated environment within a Scientific Field.
• Understanding of histological/immunohistochemical techniques.
• Work experience in a Quality Control or Quality Assurance environment.
• Experience of working to a recognized Quality Management System (e.g. ISO13485) and following quality procedures including Good Document Practice.
• Histology / immunohistochemistry and/or FISH / ISH experience including Microtomy and Microscopy
• Working knowledge of design controls for regulated products.

It would be a plus if you also possess previous experience in:

• Understands Pharma structure and drug development
• Experience of interactions with Pharma Partners

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.