Senior Product Stability Specialist

5 days ago

Solna, Sweden Cepheid Full time

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.
 

Learn about the Danaher Business System which makes everything possible.
 

The Senior Product Stability Specialist is responsible for solving complex problems, take a broad perspective to identify innovative solutions and work independently with guidance in only the most complex situations. This person plays a key role in providing technical quality support throughout the life cycle of GX assay products. The role will have daily interaction with departments such as Technical Operations, Manufacturing, New Product Introduction, Product Transfer, R&D, Quality Control, Quality Assurance and Regulatory. The Sr Stability Specialist is also expected act as a resource for colleagues with less experience. Responsible for meeting high level timelines and ensure efficient cross-functional communication in multiple projects within Product lifecycle Quality.

This position is part of the Product Lifecycle Quality and will be located in Solna, Stockholm, Sweden. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

Lead projects focusing on developing new methods for testing and establishing shelf-life for reference materials. Developing stability strategies with emphasis on control/reference material stability 'Write plans and reports, provide guidance for investigations, test method development and validations. Establish global processes for reference material handling.

The essential requirements of the job include:

University degree in Life Sciences Minimum 5 years of experience within the medical device or pharmaceutical industry Knowledge of cGMP, ISO, and FDA regulations Proficiency in Molecular Biology Techniques including PCR Experience in working in cross-functional teams in a global environment

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

Ph.D in Life Sciences Experience in test method validation Experience in Stability studies

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. 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.

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