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.
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.
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