Cepheid: Senior Manager, New Product Introduction

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)(https://www.Danaher.Com/how-we-work/danaher-business-system) which makes everything possible.The Senior Manager, New Product Introduction leads a staff of scientists representing Manufacturing Operations in cross-functional core teams for Cepheid’s GX assay development.

This person will manage and develop the NPI team as 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 expected of the Senior Manager, New Product Introduction.Responsibilities* Supervise and lead direct reports in prioritization and execution of day to day activities as well as providing annual evaluation of direct reports.* Facilitate communication and cooperation between cross-functional groups and departments.* 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:* production scale-up* process development/optimization* technology transfer* process validation* test method validation* SAP extension and costing * Develop and maintain production documentation including procedures, worksheets, and bills of materials.* Use technical knowledge to troubleshoot assay design challenges encounteredduring 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.Requirements* Master’s degree or Ph.D.

in Life Sciences, Bioengineering or Engineering with 7 years of relevant experience or Bachelors degree with 10 years of relevant experience.* Ability to manage multiple projects simultaneously with short deadlines* Ability to communicate technical issues both verbally and in written form* Effective organization and planning skills* Excellent communication skills and the ability to develop working relationships with multiple departments* Knowledge of Program Management Knowledge of statistical analysis tools* Proficiency in Molecular Biology techniquesCepheid, a Danaher 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)(https://danaherbenefitsinfo.Com/).When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win.

As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard.

We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.If you’ve ever wondered what’s within you, there’s no better time to find out.When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win.

As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful *(Danaher Business System)(https://www.Danaher.Com/how-we-work/danaher-business-system)* tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

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.The EEO posters are available *(here)(https://www.Dol.Gov/agencies/ofccp/posters)*.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.

Please contact us at (applyassistance@danaher.com)(mailto:applyassistance@danaher.com) to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.