Job Description

This opportunity will Support manufacturing operations with scientific expertise to ensure successful transfer of new products from development to manufacturing ensuring robust manufacturing processes at commercialization; failure investigation of commercialized products; support processes to ensure performance within expected parameters This role will also include laboratory assignments.

Position Summary

The Scientist, New Product Introduction represents Manufacturing/Operations in cross-functional core teams for Cepheids GX assay development. This person will be the technical partner to the R&D team throughout the life cycle of new GX assay products. Daily interaction and heavy engagement with R&D, Manufacturing Engineering, Manufacturing, and other functions within Cepheid is encouraged.

Essential Responsibilities

* Actively participate in the development of new products as a representative of Technical Operations to ensure compatibility with current and future manufacturing processes and capabilities.
* Partner with R&D team to assess manufacturability throughout the life cycle of new GX assay products. Conduct design for manufacturability (DFM) review meetings routinely.
* As appropriate, serve as a technical liaison for other departments with regards to new product introduction activities, including, but not limited to, bill of materials, reference material, reagent formulation, and product or consumables testing
* Lead, coordinate, or participate in operations-related activities required for the transfer of new products to routine production which will include:
* production scale-up
* process development/optimization
* technology transfer
* process validation
* test method validation
* SAP extension and costing
* You will develop and maintain production documentation including procedures, worksheets, and bills of materials.
* This role will use your technical knowledge to solve assay design challenges encountered during the course of assay development, clinical validation or manufacturing validation.
* Maintain substantial and current knowledge of validation and process control requirements mandated by applicable regulatory bodies.

Minimum Requirements

Education and Experience (in years):

* Bachelors degree in field with 5+ years of related work experience OR
* Masters degree in field with 3+ years of related work experience OR
* Doctoral degree in field with 0-2 years of related work experience.

Knowledge and skills:

* Experience with Real Time PCR
* Detail-oriented and multi-tasking
* Ability to work effectively with multi-functional core teams

Preferred Qualifications

* Bachelor's or Master's degree in Chemistry, Biochemistry, or Life Science +2 or more years of proven experience
* Experience with Design for Manufacturing
* Experience in molecular diagnostics development.
* Experience with Quality System Regulations.
* Familiarity with medical device regulations in US and CE markets
* Familiarity with infectious disease or cancer biology.

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked 162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.

Equal Opportunity Employer

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.

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.