Stability Specialist

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.

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The Stability Specialist, Molecular IVD Products, will apply scientific knowledge to plan, design, development, test, analyze testing data and document product stability studies; The ideal candidate will collaborate with other functional groups, including R&D, Quality, Regulatory, and Operations, with sound scientific knowledge and judgement, to ensure product shelf-life meeting product design requirement. Scientists must have degree in chemistry, biology, biochemistry and/or related area.

This position is part of the Product Life Cycle Quality & Stability team. It will be in Sunnyvale, California as Onsite position. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

• Design and execute product stability studies, using proper statistical tools to perform data analysis, generate technical reports and establish product shelf-life.

• Lead failure investigations when not meeting requirements, use scientific judgement to interpret data for theoretical models.

• Compile regulatory submission document relevant to product stability, respond to agency’s technical questions and documentary requests.  

• Interact and obtain expertise from cross-functional teams on the product performance (e.g., research and development, product transfer, regulatory, etc.), join technical meetings and present stability data, and ensure product performance meeting shelf-life requirement. 

• Manage routine stability laboratory operations, including maintaining instruments, equipment, supplies and testing materials, etc.

The essential requirements of the job include:

• Bachelor’s degree in chemistry, Biology, or related biological science with minimal 2 years of work experience; or master’s degree in relevant field.

• Good knowledge and experience with real-time PCR, and/or other molecular biology assays.

• Detail orientated with good data analysis skills. Experience with basic statistical analysis such as linear regression, analysis of variances, etc.

• Ability to work effectively in a team environment, build strong working relationships. Self-starter with a demonstrated ability to focus efforts, overcome obstacles, and prioritize multiple projects at once.

• Proficient with Microsoft Word, Excel, Visio, and Minitab.  

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

• Direct working experience in product shelf-life establishment, good understanding of CLSI EP-25 and ISO 23640.

• Knowledge of statistical study design, advanced data analysis skills in multifactorial analysis and non-linear regression modeling.

• Prior experience in Medical Device and/or IVD companies, knowledge of FDA 820 QMS requirement, ISO 13485 and ISO 14971.

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.

The salary range for this role is $87,180-$111,500. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/