Senior Product Stability Specialist

Danaher Corporation; Sunnyvale (CA); Presencial; USD 104.000 - 143.000; Jornada completa

Descripción de la vacante

Cepheid, a Danaher operating company, seeks a Senior Product Stability Specialist in Sunnyvale to drive stability strategies for GX assays and support post-launch activities. You will write plans and reports, guide investigations, and collaborate across functions with a focus on assay development and quality systems.

The role requires strong knowledge of cGMP/ISO/FDA regulations, molecular biology techniques (PCR), and cross-functional teamwork in a global environment. On-site in Sunnyvale, CA.

Formación

• Bachelor’s degree in field with 5+ years of related work experience, MS in Life Sciences with 3+ years of relevant professional experience, or Ph.D in Life Sciences with 0-2 years of relevant professional experience.
• Knowledge of cGMP, ISO, and FDA regulations
• Proficiency in Molecular Biology Techniques including PCR
• Experience in working in cross-functional teams in a global environment

Responsabilidades

• Drive assay development and post-launch stability studies, ensuring delivery against high-level timelines and effective cross-functional communication.
• Lead process improvement activities mainly within the design control area
• Lead and coach colleagues in their role as team members or extended team members in Assay Development and/or Post Launch Initiatives as well as contribute with laboratory work if needed

Conocimientos

PCR proficiency

Cross-functional teamwork

Regulatory knowledge

Molecular biology

Educación

Bachelor’s degree (Life Sciences)

MS in Life Sciences

PhD in Life Sciences

Descripción del empleo

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cepheid, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world.

Learn about the Danaher Business System which makes everything possible.

The Senior Product Stability Specialist is responsible for solving complex problems, take a broad perspective to identify innovative solutions and work independently with guidance in only the most complex situations. This person plays a key role in providing technical quality support throughout the life cycle of GX assay products. Key activities are developing stability strategies with emphasis on assay development and post launch activities, write plans and reports, provide guidance for investigations, test method development and validations.

This position reports to the Sr Manager Assay NPD Quality Assurance and is part of the Quality Assurance and Regulatory Affairs NPD located in Sunnyvale, California and will be an on-site role.

In this role, you will have the opportunity to:

• Drive assay development and post-launch stability studies, ensuring delivery against high-level timelines and effective cross-functional communication.
• Lead process improvement activities mainly within the design control area
• Lead and coach colleagues in their role as team members or extended team members in Assay Development and/or Post Launch Initiatives as well as contribute with laboratory work if needed

The essential requirements of the job include:

• Bachelor’s degree in field with 5+ years of related work experience within a medical device or pharmaceutical industry, MS in Life Sciences with 3+ years of relevant professional experience, or Ph.D in Life Sciences with 0-2 years of relevant professional experience.
• Knowledge of cGMP, ISO, and FDA regulations
• Proficiency in Molecular Biology Techniques including PCR
• Experience in working in cross-functional teams in a global environment

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Work in a laboratory environment

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

• Ph.D in Life Sciences
• Experience in data handling
• Experience in Stability studies

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 Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home).

The annual salary range for this role is between $103,500 – 142,500. 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. 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/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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.

The U.S. EEO posters are available here (http://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf).

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here (https://jobs.danaher.com/global/en/notice-to-us-candidates-based-in/applying-for-roles-outside-nyc).

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].

Operating Company: Cepheid