Product Stability Analyst

Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. In our facilities in Solna / Sundbyberg we develop and manufacture diagnostics tests that improve patient outcome all over the world


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.
- Plan and perform stability studies. Generate/present data summaries, trending and update stability reports.
- Plan and perform test method validations, other validation testing and non-routine testing.
- Revise and update product testing procedures and worksheets as appropriate to correct and/or optimize testing processes.
- Initiate, report and investigate laboratory failure investigations (LFIs).
- Interact and obtain expertise from other departments to aid in investigation activities.
- Participate in investigations with laboratory assistance.
- Perform lab duties as assigned or requested.
- Manufacture Reference and Control Materials and perform finished product testing as needed.
Minimum qualifications:
- High School degree (or equivalent experience) with 2-4 years of related work experience OR
- Technical Trade Degree with 1-2 years of work experience OR
- Bachelor's or Master's degree in Life Sciences
- Laboratory experience
- Communication skills both in Swedish & English (oral and written)
- Organization and planning skills
Preferred skills:
- Experience in Molecular Biology Techniques including PCR
- Experience in working in cGMP environment
- Combined knowledge of biology, chemistry and technology
- Experience from working in a global environment and interact with cross-functional teams
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.