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Danaher Corporation Manager, Product Stability in Sunnyvale, California

Manager, Product Stability

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 Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

The Manager, Product Stability is responsible providing management oversight of Cepheid’s Product Stability team and activities to ensure appropriate application of the stability program and compliance to FDA and ISO requirements.

Location: Sunnyvale, California

In this role, you will have the opportunity to:

  • Lead the Product Stability team to ensure compliance with Cepheid’s Stability Program and all applicable laws, regulations and standards. Define stability studies that include the use of real-time and accelerated stability protocols to establish product shelf-life.

  • Perform technical reviews of raw data to ensure accuracy, and update reports to implement product shelf-life extensions.

  • Conduct investigations and troubleshoot Out of Specification test results.

  • Efficiently deploy our Danaher Business System (DBS) tools and concepts to maximize process efficiency and effectiveness.

  • Develop key performance indicators and scorecards to measure quality level performance within the stability program.

  • Collaborate with New Product Introduction teams to ensure that quality attributes, manufacturability and lessons learned from existing products are integrated into the design and manufacturing processes.

  • Engage others, collaborate globally, promote and participate in continuous improvement initiatives.

The essential requirements of the job include:

  • Bachelor’s degree with 9+ years of related work experience OR Master’s degree in field with 7+ years of related work experience. 3 years of effective people leadership and development experience.

  • Expertise with the domestic and international medical device regulatory environment including the CE Mark, 510(k)/PMA process and approvals, FDA audits and review, design control documentation and internal guidelines.

  • Ability to present complex theoretical concepts and empirical scientific data reliably and concisely.

  • In-depth knowledge Quality standards (GMP, ISO 9000, ISO13485, etc.) and experience in the medical device industry, knowledge of CFR 21 Part 820.

  • Intermediate to sophisticated skill level of Minitab, MS Word, Excel, Access.

  • Excellent interpersonal and communication skills. Ability to work well with people. Ability to interface successfully with various departments and be a part of their teams.

  • Ability to cultivate an environment that values diversity and inclusion

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

  • Establishing product shelf-lives for Nucleic Acid Test IVDs

Cepheid, 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.

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.

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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 require all US and Puerto Rico employees to be vaccinated against COVID–19 as a condition of employment, subject to reasonable accommodation as required by law.

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 to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.

Operating Company: Cepheid

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