Product Stability Analyst

Posted 9 Hours Ago
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Solna
1-3 Years Experience
Biotech
The Role
The Product Stability Analyst supports GX assay product lifecycle by conducting stability studies, performing laboratory tasks, and generating data summaries. Responsibilities include laboratory investigations, data analysis, and interaction with R&D and Quality Assurance teams to optimize product testing procedures.
Summary Generated by Built In

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 Product Stability Analyst is responsible for providing support throughout the life cycle of GX assay products and to perform stability studies in accordance to FDA and ISO regulations. The Stability Analyst is expected to independently plan and perform stability studies, test method validations, and perform tasks and activities related to the laboratory. Other responsibilities include initiate and perform laboratory failure investigations, analyze results, and update stability reports. Interaction with departments such as R&D, Quality Control, Failure Investigation and Quality Assurance is expected. The group provides opportunities to learn statistical analysis for process control, process capability, and design of experiments (e.g. Minitab and RStudio) and to participate in improvement projects with cross-functional interactions.

This position is part of the Product Life Cycle Quality Assurance department and will be located in Solna. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:
 

  • Plan and perform stability studies by conducting laboratory work using state of the art Cepheid technology  to support post launch and new product development projects. 
  • Generate, present and trend data summaries, and update stability reports to revise and optimize product testing procedures.
  • Interact and obtain expertise from other departments to aid in investigation activities. 

The essential requirements of the job include:

  • University degree as a BMA or in Life Sciences
  • 0-2 years of work experience in Life Sciences
  • Laboratory experience including cGMP documentation practices

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

  • Proficiency in Molecular Biology Techniques and preferably experience from real time PCR
  • Computer skills including the office package
  • Good written and verbal communication skills in English

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.

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.

Top Skills

Minitab
R
The Company
HQ: Sunnyvale, CA
4,883 Employees
On-site Workplace
Year Founded: 1996

What We Do

Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid’s broad test portfolio spans respiratory infections, blood virology, women’s and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company’s solutions deliver actionable results where they are needed most – from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.

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